Tuesday, September 25 | 01:30 PM – 03:00 PM

Location: Evergreen Ballroom, Lobby Level

Category: Niche

Presentation
EVOLUTION OR REVOLUTION: HOW WILL EMERGING TECHNOLOGY INNOVATIONS CHANGE DATA MANAGEMENT?

Despite the best intent to leverage the newest technologies and comply with the recent regulation changes, most Data Management organizations have been processing data the same way for a long time. Fortunately for some and unfortunately for others, the accelerating pace of change is calling for action. The volume of data collected outside EDC is fast growing as our industry is crying for patient centricity which is leading to rapid adoption of eCOA, wearables, sensors and eSource solutions. The increasing cost of Drug Development and the need for better predictability of outcome requires use of more complex study designs such as adaptive and hybrid. Not to mention the need to embrace risk based approaches and advanced analytics. Unfortunately change will not stop there! Solutions based on Natural Language Processing, Artificial Intelligence and Machine Learning are maturing rapidly. So, is Data Management ready for all this?

Session Chairs:

• Patrick Nadolny, MS, Associate Vice President, Clinical Data Management and Programming, Allergan
• Krista Mullen, Senior Manager, Data Management, Statistics & Data Corporation (SDC)

Speakers:

• How regulations and technology will enable Digital Data Management
  Patrick Nadolny, Vice President, Product Management, Clinical Solutions Allergan 

• Will Data Management be Relevant in 5 Years?
  Stacey Yount, Vice President of Product, Medidata Solutions 

• How Artificial Intelligence and Machine Learning are Revolutionizing Data Management
  Steven Chartier, BA, MS, Senior Director of Engineering, PAREXEL Informatics 

Learning Objectives:

The objective of this session is to provide a pragmatic and concrete view on how regulations and technology innovations will change the role and profile of Clinical Data Management within the next 5 years. We will also consider changes to related functions such as Clinical Programing and Medical Coding. We will share insights and roadmap from the SCDM Innovation committee.

Session Level: Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience

CDM Certification Competencies: Clinical Trials Processes, Roles, and Responsibilities Electronic Data Collection

Target Audience: DM Leadership, Study Data Manager, Data Technologists

Tuesday, September 25 | 05:00 PM – 06:00 PM

Location: Regency Ballroom E-G, Second Floor

Category: Career Development & Leadership

BECOMING A CERTIFIED CLINICAL DATA MANAGER (CCDM®)

If you are considering professional certification or would like to learn more about it, please join us for the Becoming a Certified Clinical Data Manager (CCDM) session! This session will cover the current exam content and resources. The session will focus on preparing for the Exam including hearing from a panel of recently minted CCDMs!

Session Chairs:

• Meredith Nahm Zozus, Associate Professor and Vice Chair for Academic Programs, Department of Biomedical Informatics, UAMS College of Medicine
• Marysasser Holloway, CDM Project Manager, Syneos Health

Tuesday, September 25 | 11:15 AM – 12:15 PM

Location: Regency Ballroom A-D, Second Floor

Category: Career Development & Leadership

Panel Discussion
TRAINING THE PAST, PRESENT AND NEXT GENERATION OF CLINICAL DATA MANAGERS

How does one stay up-to-date in the ever-changing role of a Data Manager (DM)?

Training paradigms, opportunities, and resources are more limited each year. As research budgets continue to become leaner and leaner, often DM educational and professional development dollars become scarcer.

Gone are the days of a DM who possesses the entire skill set necessary to conduct all DM activities from start-up to data base lock.  Companies now focus on performing or outsourcing specific DM tasks, and the ability for a DM to see the “big picture” is waning.

In this session, we will explore the opportunities for a proactive DM (of any generation) to ensure that they have achieved the SCDM core competencies, whether sponsored by their employer or pursuing on their own.  We will review the training tools and resources that have been traditionally used in Industry and how these are being adapted for a wider research environment using today’s technologies.

Session Chair:Kelly Ritch, MS, MBA, Vice President of Strategic Partnerships, MedNet Solutions Inc.

Speakers:

• Suzi Saroukhanians, MS, Manager, Learning & Development, Gilead Sciences
• Greer McBeth, BS, Clinical Data Associate, Verily Life Sciences
• Janet Welsh, Boehringer Ingelheim

Learning Objectives:

• Self-Identify skill gaps from SCDM Core Competencies
• Learn about different types DM training opportunities
• Understand resources available for DM knowledge building

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Clinical Trials Processes, Roles, and Responsibilities

Target Audience: Data Manager, Manager, Data Management

Tuesday, September 25 | 11:15 AM – 12:15 PM

Location: Evergreen Ballroom, Lobby Level

Category: Niche

Panel Discussion

DOES THE QUALITY OF YOUR CLINICAL DATA KEEP YOU UP AT NIGHT?

In this session, Oracle Health Sciences’ Julie Smiley moderates a panel of industry experts, from Pfizer, Novella Clinical, Covance, Cytel and Premier Research, to explore their greatest challenges when it comes to clinical data management. Some of these challenges include the introduction of AI and machine learning, the influx of new data sources, and migration to the cloud. This session will offer insight into how these organizations are solving these challenges, and will shed light on what people, processes and technologies are needed in order to successfully manage clinical data.

Session Chair: Julie Smiley, MS, CIS, Senior Director, Life Sciences Product Strategy, Oracle Health Sciences

Speakers:

• Julie Barenholtz, BS, MSW, Principal Clinical Data Manager, Cyel Inc
• Melonie Longan, Premier Research
• Vicki Gashwiler, RN, BSN, Associate Director, Strategic Development & Market Access, Novella Clinical
• Carol Schaffer, Associate Director, Asset Lead, Clinical Data Sciences, Pfizer
• Casey Higgins, MBA, Vice President, FSPx, Covance

Learning Objectives:

• How new technology advancements and process improvements can increase data quality and speed clinical development.
• How sponsors and CROs are approaching these challenges, and the steps they are taking to manage the volume of data and ensure data quality.
• What critical areas to tackle first in order to avoid hidden costs or time drains in conducting clinical trials.

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

Target Audience:Study Data Manager, DM Management, Database Programmer

CDM Certification Competencies: Electronic Data Collection, Clinical Trials Processes, Roles, and Responsibilities

Sunday, September 23 | 09:00 PM – 05:00 PM

LEADERSHIP FORUM

Location: Cedar Ballroom, Second Floor

LEADING CDM FROM TODAY’S CHALLENGES TO A VISIONARY FUTURE

In a long-standing tradition, SCDM is pleased to announce the 2018 SCDM Annual Conference Leadership Forum, will take place on 23 September 2018 at the Hyatt Regency Bellevue, in majestic Seattle, Washington.

With the theme of Leading DM into the Future: Tackling Challenges of Today – Creating a Compelling Vision for Tomorrow, we will go on an exciting and highly interactive journey in three parts covering the challenges clinical data management’s leaders face today, the rapidly evolving technologies to address these challenges re-imagining the discipline of clinical data management in the future. We will explore the existing disruptive technologies that are driving this evolution, and the future of Clinical Data Management, posing the question: what does our future look like?

The day starts with an engaging roundtable discussion related to your top challenges in data management and progresses from present to future. Enhancing our three-part program will be interactive roundtable and panel discussions around the current and upcoming regulations and their impact on our work, as well as updates from the SCDM Innovation Committee.

As leaders in the industry, we invite attendees to take this opportunity connect and exchange views on challenges, regulations, innovations and trends that are currently shaping the data management world.

Facilitators:

Sanjay Bhardwaj, Global Head of Data Management, Biogen
Carol Schaffer, Associate Director, Asset Lead, Clinical Data Sciences, Pfizer

Speakers:

• Christopher P. Lamplugh, MBA, Head of Global Data Management and Standards (GDMS), Merck Research
• Demetris Zambas, VP and Global Head Data Monitoring and Management, Pfizer, Inc.
• Francois Torche, CEO, Cluepoints
• Gary Thompson, Medidata
• Gregg Dearhammer, Director, Sr. Vice President, IQVIA
• Greg Jones, Director of product strategy, Oracle Health Sciences
• Jonathan Andrus, BA, MS, CCDM, CQA, COO and Data Officer, Clinical Ink, Inc.
• Linda King, SCDM Vice Chair, Asc. Data Management Director Astellas and Incoming Chair
• MaryAnne Rizk, PhD, President, Rizk Management Consulting
• Paul Slater, Microsoft
• Patrick Nadolny, MS, Vice President, Product Management, Clinical Solutions Allergan
• Steve Chartier, PAREXEL Informatics

Tuesday, September 25 | 08:00 AM – 09:00 AM

Location: Regency Ballroom E-G, Second Floor

Category: Tech

Panel Discussion
GET OFF MY CLOUD: HOW IT INFRASTRUCTURE AFFECTS PRIVACY AND PERFORMANCE IN ECLINICAL SYSTEMS

While Electronic Data Capture (EDC) and Clinical Trial Management Systems (CMTS) streamlined the execution of clinical trials, the ultimate goal of entirely paperless trials is still to be achieved.  With a variety of new software applications emerging almost every day, data managers must be educated on these systems, EDC in particular, to fully compare and contrast their options and determine which products will be optimal for their studies. It is critical that researchers ask the important question: how and where is this software application hosted?  High cost, among other factors, has incited the movement away from on-premises hosting towards “the cloud.” Even when a researcher opts for a cloud-based clinical software, several hosting variations within “the cloud” exist. These important cloud-based hosting variations can affect both privacy and performance during the life of the study, thus affecting sponsors, as well as CROs and sites. This presentation will discuss the pros and cons that surround on-premises, public cloud, and private cloud options. Depending on a study’s needs, where and how an EDC software is hosted can have long-term and short-term implications on cost, efficiency, and compliance. It is important to be aware of the differences between these hosting options and ask the right questions when speaking to vendors. This presentation will serve as a primer to guide Data Managers through the various options and better equip them to ask the right questions.

Session Chair: Scott Weidley, CEO, ClinCapture

Speakers:

• Bruce Hallman, BS, MBA, CEO, uMotif
• Karim Damiji
• Francois Torche, CEO, Cluepoints
• Meg Richie

Learning Objectives:

• Relate IQ, OQ, and PQ validation to the technology / customer relationship
• Segment IT requirements by study scope and circumstances
• Expand the Data Manager’s role in technology selection
• Reconcile the unique needs of Data Management relative to IT infrastructure

Session level: Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience

CDM Certification Competencies: Electronic Data Collection, Clinical Trials Processes, Roles, and Responsibilities

Target Audience:Clinical Data Manager, IT, Executive Management

Monday, September 24 | 03:15 PM – 04:00 PM

Oracle Health Sciences – Product Showcase Room 1

SCDM Abstract: Three Ways to Combat Clinical Data Management Challenges

As the flood of new clinical trial data sources rapidly grows, so do the challenges around clinical data quality, traceability and oversight.

In this session, Oracle Health Sciences’ Senior Director of Product Strategy, Greg Jones, dives into a recent study that reveals insight into these current clinical data management challenges, and presents three practical ways the industry can combat these challenges in order to bring new and innovative therapies to market faster, and at lower cost.

Medrio – Product Showcase Room 2

The Benefits of a Completely Electronic Data Collection Platform: eConsent, eSource, ePRO, and EDC

The cloud has been a transformative technology for every aspect of our personal and professional lives. But while clinical trials have not adopted cloud technology as rapidly as other industries, the benefits are getting harder and harder to ignore. Decentralized workforces, trials that span the globe, and an increasing number of stakeholders are making trials more complex to manage. We will show, complete with demos, how an integrated, cloud-based data collection platform can reduce timelines, improve patient retention, simplify management, and much more.

Wednesday, September 26 | 10:30 AM – 12:00 PM

Location: Evergreen Ballroom, Lobby Level

Topic: Tech

Round Table
Clinical Trials of the Future – Where are we headed? 

This session will allow the perspectives of a wide-variety of seasoned industry personnel to share their perspective on where Clinical Trials are headed in the future and what attendees of the SCDM conference should be doing to prepare themselves for the future. An initial discussion among the panelists and the facilitator will explore topics ranging from digital health, virtual trials, artificial intelligence and connected sensors/devices, etc. Following the discussion, questions will be taken from the audience for the panelists to be able to weigh in from their perspective.

Session Chair:

Jonathan Andrus, BA, MS, CCDM, CQA, COO and Data Officer, Clinical Ink, Inc.

Speakers:

• Clinical Trials of the Future – Where are we Headed from a Sponsor Perspective?
  Erica Lawson, BS, Director, Business Information Management, Otsuka Pharmaceuticals 

• Virtual Future – Reaching the Masses with Minimal Impact 
  Emily Mitchell, BS, Director – Biometrics Portfolio Operations PRA Health Sciences

• Clinical Trials of the Future – Where are we Headed from a Large Sponsor Perspective?
  Demetris Zambas, VP and Global Head Data Monitoring and Management, Pfizer, Inc. 

• Clinical Trials of the Future – Where are we Headed from a Technology Vendor Perspective?
  Sean Vassilaros, THREAD

Learning Objectives:

• Assess the ideas and information shared for use within a given clinical trial
• Evaluate the different ideas and thoughts shared for use within a respective organization
• Determine whether the benefits outweigh the challenges associated with different clinical trial approaches
• Recognize the types of clinical trials that would benefit from the innovative approaches presented during this session

Session Level: Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience

CDM Certification Competencies: Clinical Trials Processes, Roles and Responsibilities, Electronic Data Collection, Project Management

Target Audience: DM Management, Clinical Research Management, Clinical Research Executives

Tuesday, September 25 | 01:30 PM – 03:00 PM

Location: Regency Ballroom A-D, Second Floor

Category: Tech

Ignite

DATA MANAGEMENT IN 2020, AND BEYOND

The session is a play on FREAKONOMICS, and in particular the TELL ME SOMETHING I DO NOT KNOW series.

Each presenter will be invited, in turn, to persuade the audience, and a panel, that their chosen fact or idea will transform our industry more than any other in the next 5 years. Each presenter has been selected because of their deep domain knowledge, but also for their ability to be imaginative, concise, precise and above all convincing and compelling.

Each presenter will have just 12 minutes to persuade, to convince and to make their case. After 12 minutes (strictly adhered to), there will be a 5 minutes opportunity for the panel to ask questions.
There are only 2 rules:
•Each presenter must stick to their own topic, and cannot look outside of your topic
•There are no other rules

We will repeat until each of the 4 presenters has completed their turn. After each presenter has delivered their pitch, we will turn to the audience and the panel (independently) to vote. The panel will be formed from some executives in our industry and will be neutral to all. I do not get to vote! In other words, this is all about pitching the 4 presenters against each other (in fun) and then letting the audience pick a winner.

There will be a prize for the panel winner, and the audience winner. It will be interesting to see if we have one winner take all!

Session Chair: Richard Young, VP, Vault EDC, Veeva Systems

Speakers:

• The New Investigator
  Mike Ryan , TrialSpark 

• The New Patient
  Bruce Hellman, BSc, MBA, CEO , uMotif 

• The New Decision Maker
  Karim Damji , Saama 

• The New Technology
  MaryAnne Rizk, PhD, President of Rizk Management LLC

Learning Objectives:

• The New Investigator
  • How are the roles of the Investigator changing?
  • How does this impact our approach to clinical trials?

• The New Patient
  • What does the new Patient look like?
  • What is their expectation for participating in trials, and how does this impact our approach to clinical trials?

• The New Decision Maker
  • What does the new decision maker look like?
  • What data will they demand, and how?

• The New Technology

• What does the new technology of the future look like?
• How will this impact us, and why?

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies:

Target Audience:

Monday, September 24 | 04:00 PM – 05:30 PM

Location: Evergreen Ballroom, Lobby Level

Category: Tech

Panel Discussion

COMBINING STANDARDS AND TECHNOLOGY TO ACCELERATE TIMELINES AND EFFICIENTLY MANAGE CLINICAL TRIAL DATA

As technology advances and standards are mandated, industry has been able to build applications that change the way we build databases, manage standards, review, clean and manage clinical trial data. This session will explore how industry representatives from multiple disciplines consume these standards and use these technologies in their jobs. Now is your chance to ask the questions that management asks you:

• How can we accelerate timelines?
• How can we increase quality?

This panel discussion will address:

• Metadata registry – what is it and how does it help me?
• Benefits of applying standards end to end in a clinical trial
• Clinical Data warehouse with analytics – opening your eyes and seeing data the way it was meant to be

All 3 applications are based on CDISC standards. Each speaker will provide “real world” examples how the application impacts timelines and improves efficiencies.

Session Chair: Dan Crawford, Director Data Solutions and Business Development, eClinical Solutions

Speakers:

• Using clinical Data and Clinical Trial Analytics to Improve Data Quality

Dawn Kaminski, BS, Biology, Senior Director, Data Strategies, eClinical Solutions 

• What is a Metadata Registry (MDR) and How Can it Impact Data Management Processes

Shannon Labout, Chair, Data Science Solutions LLC

• How can CDISC Standards Reduce Timelines in the End to End

Mark Wheeldon, CEO, Formedix 

Learning Objectives:

• Understand the latest technologies available in Clinical Data Management based on Standards
• Understanding the benefits as these standards and technologies are applied throughout the various stages of a clinical trial or overall Data Management process
• Understand how and why efficiencies are gained when utilizing these standards and technologies
• Thinking about the future and one place to store, utilize and visualize clinical trial data

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Clinical Trials Processes, Roles, and Responsibilities, Clinical Database Design/Relational Data Bases, Electronic Data Collection

Target Audience: Data Manager, Programmer, Data Management

Monday, September 24 | 04:00 PM – 05:30 PM

Location: Cedar Ballroom, Second Floor

Category: Tech

Presentation

LEVERAGING HIGH IMPACT INFORMATION: LESSONS AND BEST PRACTICES IN A DATA DRIVEN CULTURE

Every company aim is to make sense of its data to help predict trends and make informed decisions. Even after the procurement of new technologies, companies struggle to find meaningful evidence that tell a story. In this session, we explore effective measurement of clinical data management and unique ways to make your data flashy again.

 Session Chair: Jennifer Price, Senior Director, Clinical Data Management, Paidion Research

 Speakers:

• Benchmarking for Effective Measurement of CDM Performance

Nigel Freemantle, BSc, MS, C.Stat., Operations Director, Global Data Management & Standards, Merck Sharp & Dohme Corp.

• Big Data, Too Big? – Effective strategies to get to the answers you really need from your large datasets

Steve Shevel, MS, MBA, Senior Associate, Waife & Associates

•  Conversational Interfaces to Reveal Data Insights

Jean-Remy Behaeghel, Senior Director, Clinical, Quality and Manufacturing Systems, Vertex Pharmaceuticals

Learning Objectives:

• • • • • New visualization techniques and technologies
        • How the SCDM is developing a core set of KPIs for Clinical Data Management, and how we plan to use it to benchmark across companies and academic organizations engaged in clinical research
        • How to obtain data from API’s for use in your dashboard
        • Learn about the concept of conversational interfaces and how they can be applied to data problems

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Clinical Database, Design/ Relational Data Bases, Processing External Data

Target Audience: DM Management, Exec Management, Study Data Manager

Monday, September 24 | 01:45 PM – 03:15 PM

Location: Cedar Ballroom, Second Floor

Category: Data Review

Presentation

LET’S DTQR: DEFINE THE QUALITY RELATIONSHIP OF DATA MANAGEMENT WITHIN CLINICAL TRIALS

Focus and emphasis of quality control throughout data management processes. Diverse presentations across key areas of concern for data management including but not limited to data integrity, defining quality and best practices. At the conclusion of each presentation interaction will be encouraged through a question and answer session as well as open discussion. The forum to present information and have active conversation around methodology and best practices. Possibility of exercises upon conclusion of presentations to promote communication and ensure the understanding of what has been presented.

Session Chair: Sara Doolittle, Premier Research

Speakers:

• • A Relationship Story; Data Management & Quality Control

Cecilia Calcagno, Lead Data Manager, PRA Health Sciences 

• • • A Key Relationship Trait; Integrity

Melonie Longan, Director, Data Operations, Functional Services,Premier Research
Charity Conner, Associate Director, Data Management, Alkermes, Inc.

• • • • A Relationship Check-In; Metrics

Nigel Freemantle, BSc, MS, C.Stat., Operations Director, Global Data Management & Standards, Merck Sharp & Dohme Corp.

• • • • • • Relationships Experience & Moving Forward

John Manlay, MS, Director Clinical Data Sciences, Pfizer, Inc.
Muzafar Mirza, Director Clinical Data Sciences, Pfizer, Inc.

Learning Objectives:

• • • • • • Ability to define what quality is
          • Understanding the importance of quality in research
          • How to apply use metrics to gauge quality
          • Why quality is a key responsibility for data management roles

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Quality within Clinical Trials

Target Audience: Data Managers, Management

Monday, September 24 | 11:15 AM – 12:15 PM

Location: Regency Ballroom A-D, Second Floor

Category: eConsent

Panel Discussion

ESOURCE

Discuss the current projects based on standards for the secondary use of EHR data for clinical research.

 Session Chair: Amy Nordo, MMCI, RN, CPHQ, eSource for regulated Clinical Trials, Duke University

Speakers:

• • Michele Cherry, Pfizer
  • Meredith Zozus, Univeristy of Arkansas for Medical Sciences
  • Anita Walden, University of Arkansas for Medical Sciences
  • Scott Gordon, FDA
  • Amy Jo Jenkins, University of Arkansas for Medical Sciences

Learning Objectives:

• • • Participant will comprehend two different interoperability standards that could be used for eSource.
    • Participant will comprehend the application of the Fast Healthcare Interoperability Resources (FHIR) for eSource.
    • Participant will be able to synthesis the perspectives of the panelists into a single solution for eSource.
    • Participant will evaluate the eSource solutions provided.

Session Level: Expert – Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience

CDM Certification Competencies: Clinical trials processes, roles and responsibilities, Electronic data collection, Data management plans

Target Audience: DM Management Programmer, Study Data Manager

Monday, September 24 | 11:15 AM – 12:15 PM

Location: Cedar Ballroom, Second Floor

Category: Data Review

Presentation

HARNESSING NEW TECHNOLOGIES TO IMPROVE DATA REVIEW EFFICIENCY

As clinical trials become increasingly complex involving data obtained from varying sources, tapping into the extensive array of new technologies and visualizations can enable teams to maximize their efforts and strengthen the integrity of the data.  This session will highlight practical strategies that data management teams can implement while working with vendors and differing data sources. Speakers will present some key examples in which we can justify that applied technology leads to increased efficiency resulting in quality data.

 Session Chair: Amy Wanamaker, CCDM, Program Clinical Data Manager, Neon Therapeutics

 Speakers:

• • Systematizing Multi-Site Multi-Vendor PET/CT Scanning in a Clinical Trial

Michael Duvenhage, Clinical Trials Data Operations Manager, Leidos Biomedical Research Inc. 

• • • Utilizing Free Source Visualization Tools to Effectively Manage Big Data in Clinical Trials

Veronica Vu, BA, Clinical Data Manager, Advanced Clinical 

• • • • What’s Trending in Compliance

Stella Jouldjian, MS, Clinical Data Analyst, Abbott

Learning Objectives:

• By learning how to use data visualizations and dashboards, attendees will be able to track performance over time and identify outliers in data to increase accuracy of data
• Given examples of how being proactive in identifying barriers in productivity, attendees will be better poised to take corrective actions to address performance issues
• Through examples showing creative applications for common technologies, attendees will be able to apply new vision to creating workflow improvements
• After seeing how small changes can make big differences in workflow, attendees will be able to identify improvements leading to increased efficiency

Session Level: Expert – Assumes advanced understanding of CDM industry; 6+ years’ experience

CDM Certification Competencies:

Processing External Data, Clinical Database Design/Relational Data Bases, Data Base Quality Control Audits

Target Audience:

DM Management, Programmer. Study Data Manager

Monday, September 24 | 11:15 AM – 12:15 PM

Location: Evergreen Ballroom, Lobby Level

Category: Career Development & Leadership

Ignite

EVERYTHING I KNOW I LEARNED IN DATA MANAGEMENT
Leaders from a variety of businesses, who all began in Data Management, will share what they learned in CDM and how they have applied it in their careers and in their current roles.  Attendees will gain an appreciation of how they can use the knowledge and expertise from a CDM background in a broader career pathway.

Session Chair: Gregg Dearhammer, Director, Sr. Vice President, IQVIA

Speakers:

• Steve Powell
• John Rodermund
• Katherine Vandebelt, BSc, Chief Ecosystem Officer, Reify Health
• Anthony Costello, VP Mobile Health, Medidata
• Tracey Lythgoe, Sr. Director, Site & Patient Services, Real World Evidence, QVIA

 Learning Objectives:

• Attendees will gain an appreciation for how their CDM skills can further their career

Session level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Electronic Data Collection, Processing Local Lab Data, Data Base Updates Data Base Lock Procedures

Target Audience: Study Data Manager, Mid-Level/ new CDMs, Leaders with past CDM experience

Sunday, September 23 | 01:00 PM – 05:00 PM

 PRE-CONFERENCE WORKSHOP: PREPARING DATA FOR FDA SUBMISSION

Location: Regency Ballroom E-C, Second Floor

 Workshop Leader: Fred Wood, Vice President, Consulting Services, Data Standards Consulting

Topics to Be Discussed:

• History of providing data and related assets to the FDA FDASIA, PDUFA V and the recently finalized binding guidance documents covering electronic submissions and standardized study data.
• Submission Data Packages – what to include, how to create them, things to consider
• SDTM domain datasets & ADaM analysis datasets
• Data definition files (define.xml & define.pdf)
• Annotated CRFs
• Study Data Reviewer’s Guides, Analysis Data Reviewer’s Guides, and Study Data Standardization Plans
• How to effectively design, execute and archive your clinical trial assets in order to successfully generate submission data packages and related deliverables
• Review of live examples of source/ legacy and standardized submission data packages

Learning Objectives:

• Understand the foundations for the FDA acceptance of clinical data and related assets and how the expectations for process and format of these deliverables have recently changed
• Be aware of agency expectations for the use of data standards at the time a study is planned/ designed, including the use of CDASH standards for data collection
• Be capable of executing a clinical trial with a focus on both immediate study execution needs and preserving all assets for use at the point in time final submission deliverables are generated
• Be able to recognize the various assets, including both items generated in a Data Management/ EDC setting and those produced by other capabilities

Target Audience: CDM Leadership, CDMS Programmer, Study Data Manager

Continuing Education Credits: SCDM is authorized by IACET to offer 0.4 CEUs for this program.

Tuesday, September 25 | 08:00 AM – 09:00 AM

Location:

Category: Career Development & Leadership

Roundtable
“DON’T YOU (FORGET ABOUT ME),” THE BREAKFAST CLUB…OF DATA MANAGEMENT!

Interactive session featuring people from different backgrounds, experiences and expertise. Each will bring their own perspective of Data Management, and will allow, along with audience participation, a lively discussion on how we can work together to make our roles better.  Sometimes the best ideas, or advice, come from the person you least expect.

Session Chair: Kate Solomon, CCDM, Lead Data Manager, PRA Health Sciences – PPD

Speakers:

Kelly Ritch

• ,

MS

• ,

MBA

• , Vice President of Strategic Partnerships,

MedNet Solutions Inc.Kimberly Rivera

• ,

BA

• , Director, Data Monitoring & Management,

PfizerLeigh Bobowski

• ,

BS

• ,

CCDM

• , Associate Director, Data Monitoring & Management,

Pfizer

 Learning Objectives:

• To be open to the idea of working with people outside your department.
• Willingness to think outside the box
• Seeing the role of the Data Manager from the “other side of the computer”
• To learn how SCDM can benefit them

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Clinical Trials Processes, Roles and Responsibilities, Project Management

Target Audience: Lead Data Managers, Clinical Data Coordinators, DM Management

Wednesday, September 26 | 10:30 AM – 12:00 PM

Location: Cedar Ballroom, Second Floor

Category: Tech

Presentation
TIME TO MUTATE: HOW EMERGING TECHNOLOGIES WILL SHAPE THE FUTURE ROLE OF DATA MANAGEMENT
With aspects of clinical research seeing rapid expansion into more automated and advanced approaches to day-to-day work tasks, clinical data management is nearing a required adoption of more sophisticated methods of mining study metadata, identifying and cleaning anomalous data, and working with a wider variety of available data sources beyond the traditional electronic data capture (EDC) system model, including EMR/EHR systems. As clinical trials continue to move toward the use of ePRO, wearable technology, and biosensors for data collection, data volume and data velocity will likely render non-algorithm based approaches to data cleaning and error identification obsolete. Deep learning, predictive analytic and machine learning algorithms will become commonplace tools available to clinical data management to expedite and, in some cases, eliminate tasks that have traditionally been handled manually. In addition to the standard arena of clinical data, there are a number of non-traditional areas in which clinical data management is likely to expand. That being said, there is a salient concern that Data Management as it exists today will not have a place in the clinical research enterprise in a future potentially dominated by AI applications. In order to keep up with current trends and remain relevant, those in clinical data management positions must be ready to adapt to the rapidly-changing landscape. This session will be description of the gap between the current state of our industry and where we are likely to find ourselves in the near future based on the evolution of data systems and technology. In addition, we will attempt to paint a clear and actionable path to improving our skill set for those in Data Management today.

Session Chair: Derek Lawrence, BA, Operational Service Lead, Data Management, Rho, Inc.

Speakers:

• Scaling Data Cleaning Through Automation, Statistics, and Data Visualization
  David Hall, PhD, Senior Research Scientist,  Rho

• From Spreadsheets to Artificial Intelligence: How Do We Get from Here to There?
  Charlotte D’souza, MS, Senior Medical Coder, Syneos Health 

• When Artificial Intelligence Meets Clinical Data Management
  Sunil Agarwal, MS, AVP and Head – R&D Business Consulting, HCL America Inc.

Learning Objectives:

• Learn about the current state of the Data Management role across industries
• Describe the challenges the DM role will face with the adoption of new technologies
• Discuss the potential benefits from advances in technology & tools may have on our industry
• Outline opportunities for those currently in DM roles to evolve & expand their individual capabilities

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Clinical Trials Processes, Roles, and Responsibilities, Processing External Data, Data Query Processing and Tracking

Target Audience: Clinical Data Manager, Statistical Programmer, Statistician

Wednesday, September 26 | 10:30 AM – 12:00 PM

Location: Regency Ballroom A-D, Second Floor

Category: Career Development & Leadership

Panel Discussion
BEING DIGITAL CLINICAL DATA MANAGER, WHAT IT MEANS FOR THE INDUSTRY! – A VISIONARY APPROACH TO REVOLUTIONIZE CDM PRACTICES

The Clinical Research Industry is currently at a Juncture where disruptions are happening in Clinical Data Management process and the role of Clinical Data Manager seems to evolve as a Digital Data Manager. Here is the reason:

• ATOM (Analytics – Big Data, Risk Based Monitoring)
• Technology – Automation of many processes
• Tool and accelerators to reduce manual work
• BOTs to do repetitive task
• Overflow – Social Media
• Mobile and IOT is creating an overflow of the data to manage, retain, analyze to make sense of it, Mediation
• e-Source and connected devices requires mediation of the new way of doing clinical research which is not fully executed and explored.

So, from just managing clinical data, it will evolve to lead many digital initiatives and would be called as Digital Data Manager.

Session Chair: Sangeet Kumar, Cognizant Technology Solutions

Speakers:

• Aman Thukral 

• Raghavendra Kalmadi, Senior Director, Clinical Data Management, IQVIA 

• Jagat Mishra, MS, Clinical Data Analyst II, PAREXEL International 

• Mayank Anand, MS, Senior Director, Syneos Health

Learning Objectives:

Session Level: Expert – Assumes advanced understanding of CDM industry; 6+ years’ experience

CDM Certification Competencies:

Target Audience:

Wednesday, September 26 | 08:30 AM – 10:00 AM

Keynote Presentation – Kaye Fendt, MSPH

Clinical Data Integrity : The Central Role of the Data Manager 

The role of data management professionals in the science of clinical trials continues to be central to the integrity of the data relied upon as evidence for important health decisions. The environment for the clinical research enterprise is rapidly changing. Significant milestones in the development of data management as a profession, changes that impact the data integrity including a discussion of the origins of the SCDM, the origins and purpose of the GCDMP and other standards will be provided. The importance and future role of SCDM to advance the profession of data management, changes in data management and information science, and experience needed in the development of this profession will be discussed.

Closing & Award Ceremony

Tuesday, September 25 | 03:30 PM – 05:00 PM

Location: Regency Ballroom A-D, Second Floor

Category: Career Development & Leadership

Presentation
THE INSPECTION EXPERIENCE THROUGH THE EYES OF A DATA MANAGER
Being involved directly in an agency inspection is a very unique experience and although these can be high intensity situations and a little stressful, the opportunity for learning by being involved in them is invaluable. Since not every data manager will directly be involved in an inspection over the life of the career, it is still imperative that all DMs have a good idea of how they work and how DM is involved and impacted.  It will be very valuable to all data managers to really get a good feel for what is expected, from DM, related to an inspection using real life experiences. Understanding how an inspection happens and examples of questions asked and scenarios experienced can give any data manager a much better idea about how their work directly relates to the potential discussions during an inspection. During this session, data managers across the clinical data management industry will share their experiences and involvement in inspections.

Session Chair: Maria Craze, MBA, BS, Executive Director Global Data Operations, Merck & Company, Inc.

Speakers:

• A CDM in the inspection room? The Sponsor Inspection Experience through the eyes of a CDM
  Daniela Munoz, PhD, Manager and Operations Lead, MSD Columbia
  Diego Gayon, BA, Manager and Operations Lead, Merck & Co. Inc 

• Experience Sharing from CFDA Inspection
  Qingyuan Zhou, MS, Clinical Data Manager, Boehringer Ingelheim China 

• The Golden Rules of Inspection Readiness for a CDM
  Pat Stetser, Senior Lead Data Manager, PRA Health Sciences

Learning Objectives:

• Attendees will be able to understand how data managers have historically interacted with health authorities
• Attendees will appreciate the different health authority inspection experiences fellow data managers have encountered through experiential presentations
• Attendees will be able to understand how information learned through health authority inspections can be translated into process improvements to limit and/or prevent data management related findings and observations later
• Attendees will be able to define the key steps they can start to take in their business to support data managers interacting with health authorities

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Clinical Trials Processes, Roles and Responsibilities, Data Base Quality Control Audits

Target Audience: Study Data Manager, DM Management, DM Programmers

Tuesday, September 25 | 03:30 PM – 05:00 PM

Location: Evergreen Ballroom, Lobby Level

Category: Tech

Presentation
EHR INTEGRATION USING SMART ON FHIR

SMART is an architecture whereby cloud-based third-party applications may be launched from within an EHR system. FHIR provides a compact and efficient mechanism for securely retrieving appropriate data from the Electronic Health Record. The combination finally provides the “holy grail” of clinical data collection, namely the ability to programmatically extract relevant clinical trial data from the Electronic Health Record, without needing to install anything at the investigative site. This session will describe the technologies, processes and recommended workflow to achieve this dream.

Session Chair: Keith Howells, OmniComm Systems Inc.

Speakers:

• Ken Light, MS, EVP, Corporate Strategy, OmniComm Systems Inc.
• Aanchal Asthana, MS, Clinical Data Manger, Syneos Health
• Shraddha Modh, MD, MBA, Associate Clinical Data Coordinator, PRA Health Sciences

Learning Objectives:

• Gain an overview of the SMART architecture for plug-in EHR applications and the FHIR protocol for retrieving healthcare data
• Understand the mechanics of retrieving healthcare data and transmitting it to an EDC system
• Understand the workflow and monitoring implications when healthcare data retrieved automatically
• Appreciate the compliance and patient privacy considerations

Session Level: Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience

CDM Certification Competencies: Electronic Data Collector, Clinical Trials Processes, Roles and responsibility, Project Management.

Target Audience: Study Data Manager, Programmer, Monitor

Tuesday, September 25 | 03:30 PM – 05:00 PM

Location: Regency Ballroom E-G, Second Floor

Category: Tech

Panel Discussion
SINGLE SOURCE OF TRUTH, INTEGRATIONS OR IOT (INTERNET OF THINGS): EXPLORING WAYS TO IMPROVE CONNECTEDNESS OF CLINICAL DATA

With technology capabilities growing exponentially, and the ever-increasing complexity of clinical research, the pace of innovation relevant to clinical data management is changing rapidly. eSource, mHealth, RBM, IRT, CTMS, Data Warehouse systems and more are capturing some or most of the data that would traditionally be captured by EDC systems. The challenge, however, is that these disparate systems and processes are creating multiple versions of truth for the same data – adding to, instead of reducing, trial complexity. Current attempts to solve this challenge through the integration of clinical research systems is falling far short of the goal, and can in fact create greater inefficiency, adding time and effort to the overall management of data and potentially impacting data quality.
This panel discussion will explore the hard questions life sciences companies face are addressing these challenges in today’s CDM world, and what they are doing about them, including:

• Is a “single source of truth” for clinical data the way forward? Is it really possible?
• What are the current challenges with integrations between clinical research products and systems?
• What are the best practices to make the integrations work better?
• What can we learn from other regulated industries such as finance and its application of new technologies such as blockchain to solve data challenges in life sciences?
• How will greater connectivity of clinical data make data managers and data scientists more productive?
• How can we leverage the Internet of Things to have better connected and integrated clinical research systems – while maintaining informed consent and data privacy?

Session Chair: Joby John, BA, Senior Director, eHealth Operations, Bioclinica

Speakers:

• Mayank Anand, MS, Senior Director, Syneos Health
• Kelly Ritch Kelly Ritch, MS, MBA, Vice President of Strategic Partnerships, MedNet Solutions Inc.
• Nick Neri, BS, Director, Data Integration & Services, ERT
• Jennifer Price, Senior Director, Clinical Data Management, Paidion Research

Learning Objectives:

• Learn about why, what, where, when and how of data integrations between clinical systems
• Discover the recent technologies in the CDM world and how these technologies are increasing the need for efficient integrations
• Understand current challenges in data integrations between clinical systems
• Learn about ways to improve efficiency of integrations and use cases where technology has improved integration

Session Level: Advanced Expert – Assumes deep knowledge of the CDM industry; 8+ years’ experience

CDM Certification Competencies: Processing External Data, Clinical Database Design/ Relational Data Bases, Electronic Data Collection

Target Audience: DM Management, Teams working on Data Integration, Clinical Project Manager

Tuesday, September 25 | 01:30 PM – 03:00 PM

Location: Cedar Ballroom, Second Floor

Category: Niche

Presentation
UTILIZING GCDMP AS A TRAINING TOOL FOR CLINICAL DATA MANAGERS

Data Management has become more complex in the past couple of decades. To address this complexity, organizations need to train their Data Management staff on the best practices to assure the quality of the data at the end.

In this session, presenters from four different countries (Unites States, Japan, China, and India) will share their journey in using GCDMP to train their Data Management staff on best practices in their organizations. The presentations will encourage other organizations to utilize GCDMP in an effective manner to increase quality of their processes and data.

Session Chair: Reza Rostami, MBA, CCDM, Associate Director, Duke Clinical Research Institute

Speakers:

• Utilizing GCDMP for CDM education in Japan
  Tempei Miyaji, MS, Project Assistant Professor, The University of Tokyo               

• Be a Mentor for New DM to Begin the Daily Routine Work
  Dongyan Chen, CCDM, Clinical Data Manager, dMed Biopharmaceutical Company Ltd.     

• GCDMP – A Bible for the Clinical Data Manager to understand, to lecture and to follow its path
  Krishnaveni Thanappan, MS, Clinical Data Coordinator, Navitas Life Sciences 

• Good Clinical Data Management Practice (GCDMP) for Academic Research Organization (ARO)
  Hong Yu, Director of Data Management, Neurological Clinical Research Institute, Massachusetts General Hospital        

Learning Objectives:

• Learn from case studies on use of GCDMP in DM departments in four different countries (US, Japan, China, India)
• Utilize GCDMP in an effective way to train Data Managers in best DM practices
• Apply the DM best practices to improve quality of data
• Decide on the best way to apply the knowledge learned in their organizations

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Clinical Trials Processes, Roles, and Responsibilities, Project Management, Data Management Plans

Target Audience: Clinical Data Managers, Head of Clinical Data Management, Quality Management Group

Tuesday, September 25 | 11:15 AM – 12:15 PM

Location: Cedar Ballroom, Second Floor

Category: Niche

Panel Discussion
COALESCING RESEARCH DATA SERVICES AND ENABLING DATA SCIENCE AT ACADEMIC MEDICAL CENTERS

Academic research institutions support multi-center and site based research through significant institutional infrastructure, resources and technologies for collecting and managing data for clinical studies, and enabling data from EHR warehouses to support studies integrated within the healthcare environment. Industry sponsored projects leverage these capabilities while also fulfilling their distinct scientific, regulatory and business needs. Data and data management practices at the intersection of these stakeholders present unique opportunities to collaborate and advance research practice while recognizing the different needs and requirements represented by those different perspectives. Come learn about the trends and key challenges facing the SCDM membership from principal investigators (PIs), administrators, and others who hold leadership roles in academia.

Session Chair: Emily Patridge, University of Washington

Speakers:

• Meredith Zozus, University of Arkansas for Medical Sciences
• Jason Morrison, Director of Research Information Technologies, University of Washington
• Brian McCourt, Director, Data Solutions, Duke Clinical Research Institute

 Learning Objectives:

• Participants will be able to identify the research data cycle in academic settings
• Participants will learn about key challenges in academic data management
• Participants will be able to tell their colleagues about the use of EHR warehouses in academic settings
• Participants will learn about collaborative partnerships in academic settings

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Project Management, Electronic Data Collection and Data Management Plans

Target Audience: Data Management Administrators, Programmer, Academic Personne

Tuesday, September 25 | 11:15 AM – 12:15 PM

Location: Regency Ballroom E-G, Second Floor

Category: eConsent

Panel Discussion

MORE THAN CHECKING BOXES: INTEGRATING ELECTRONIC INFORMED CONSENT IN A COMPLIANT AND ETHICAL WAY

Regulatory authorities have been clear that Informed Consent is a multifaceted process that goes far beyond obtaining a signature. Genuine consent involves providing potential participants with adequate information about the research to allow for an informed decision to participate, facilitating and verifying comprehension of the information, and allowing adequate opportunity for questions and consideration. The process often continues after enrollment. Investigators are frequently obligated to provide additional information to participants as the research progresses, and even obtained informed re-consent.

Electronic informed consent (e-Consent) must accommodate all these requirements. Done well, e-Consent can maximize patient understanding, engage non-English speakers with multilingual tools, improve documentation and reporting, and standardize the consent process across sites, all while reducing cost and administrative burden. Attendees of this session will learn how to determine the suitability of e-Consent in light of a study’s setting, participant profile, and indication (among other attributes), as well as the best way to adapt the principles of fully informed consent in its usual, paper-based context to one where the process is electronic.

Session Chair: Cal Collins, AB, CEO, OpenClinica LLC

Speakers:

• John Wilbanks, Chief Commons Officer, Sage Bionetworks
• Kristen Warren, Clinical Operations Manager, DxTerity
• Kevin Johnson, Cardiovascular Research Project Manager, Intermountain Healthcare
• Brittany Stark, Project Manager II, Professional Services, OpenClinica, LLC
• Sandra Sather, Clinical Pathway Research
• Vincent Miller, MMCI, Project Leader, Duke Clinical Research Institute

Learning Objectives:

• Translate the requirements of informed consent in its usual, paper-based context to one where documentation is electronic
• Understand which contexts are suitable for electronic informed consent, which are not, and which allow for a hybrid method
• Leverage interactive forms and media to improve patient understanding and better document their comprehension and consent
• Accurately project the time and cost-efficiency gained for a study that relies on e-consent

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Clinical Trials Processes, Roles, and Responsibilities, Electronic Data Collection, CRF Design

Target Audience: Clinical Data Managers, Compliance Officers, Clinical Operations

Tuesday, September 25 | 09:00 AM – 10:30 AM

Location: Evergreen Ballroom, Lobby Level

Category: Tech

Panel Discussion

REGULATORY PANEL

The annual SCDM Regulatory Forum will offer participants an opportunity to engage our panelists from the FDA on current key topics concerning Clinical Development and the Data Management discipline. In addition to specific updates the panelists will provide, participants will be offered to the opportunity to ask their questions during the Q&A portion of the session. Do not miss the chance to determine what is critical to our regulators, to your peers, to you and your organization.

Moderator: Demetris Zambas, VP and Global Head Data Monitoring and Management, Pfizer, Inc.

Speakers:  

• Kassa Ayalew, MD, MPH, Doctor, FDA 
• Gideon Scott Gordon, Ph.D. , Senior Health Informatics Officer, FDA

Tuesday, September 25 | 08:00 AM – 09:00 AM

Location: Cedar Ballroom, Second Floor

Category: Niche

Presentation
GCDMP REVISION HIGHLIGHTS
You’ve heard that chapters were under revision. You’ve seen notices for the draft chapter webinars. Now they’re here! This session will present revisions to key GCDMP Chapters including Data Management Plan, CRF Completion Guidelines, Vendor Selection and Management and the EDC Chapters. Come hear what’s new, how to comment on the draft chapters and how to participate in this major GCDMP revision.

Session Chair: Meredith Zozus, University of Arkansas for Medical Sciences

Speakers:

• Carolyn Famatiga
• Dawn M. Edgerton, MBA, RAC , Owner, Edgerton Data Consulting, LLC
• Maxine Pestronk, MS, RD, LDN, CCDM, Founder, P4CDM

Monday, September 24 | 04:00 PM – 05:30 PM

Location: Regency Ballroom A-D, Second Floor

Category: Career Development & Leadership

Panel Discussion

VIRTUAL TRIALS AND THE DATA MANAGER

This session aims to look at the concept of virtual trials and patient centric research through the eyes of a data manager. We’ll look at how using eSource and patient dashboards will challenge the traditional role and tools of a data manager.

Session Chair: Stephen Cameron, Senior Manager, Clinical Data Management, PRA Health Sciences

Speakers:

• Emily Mitchell, BS, Director, Biometrics Portfolio Operations, PRA Health Sciences

• Arshad Mohammed, MBBS, Senior Director, CDM, IQVIA

• Shani Sampson, BA, Data Enablement Manager, GSK

• Wayne Walker, BSc, Vice President of Product, Study Conduct Solutions, Medidata Solutions

Learning Objectives:

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies:

Target Audience:

Monday, September 24 | 01:45 PM – 03:15 PM

Location: Regency Ballroom E-G, Second Floor

Category: Niche

Ignite

TECHNOLOGY IGNITE – SPARK THE FUTURE

This session will be unique in its presentation format. The six selected speakers who will entice you with a brief look into their world and a recent accomplishment. Each presenter will share a key example of something they have created and delivered within their organization that shows creativity and overcoming everyday challenges in Data Management. The presentations will each be approximately 10 minutes with time at the end of the session for Q&A. These speakers will Spark your Interest and Ignite your Future!

Attendees will have the opportunity to vote through the mobile app the most interesting and creative presentation in this session. The People’s Choice Award will entitle its winner to a two minutes podcast to promote their accomplishment, on the SCDM website and social media channels.

Session Chair: Debra Jendrasek, BS, Adaptive Clinical Strategy Partner, Premier Research

Speakers:

• The Trial of the Future is Now: What we Learned from THE ADAPTABLE Study

Anthony Costello, VP, Mobile Health, Medidata

• Project Baseline: Leveraging Data to Map Human Health Through Intentionality and Interoperability

Ashley Moulton Hanks, BS, Clinical Data Management Lead, Verily Life Sciences 

• How Gilead cut two weeks off EDC Build Timelines

Jeff Sonas, BS, Owner, Sonas Consulting

• A One Stop Shop for Data Review

MacKenzie Tweardy, MS, BME, Data Sciences Associate ii, Abbvie 

• Accelerate Database Lock with Clean Patient Optics

Joby John, BA, Senior Director, eHealth Operations, Bioclinica 

• Achieving System-Wide Efficiencies by Inverting the Focus from a Single Trial to the SITE

Shree Kalluri, Founder, President, CEO & Chief Customer Officer, Forte Research

Learning Objectives:

• Become knowledgeable about new technologies available in the industry
• Be more open to innovative ways of doing routine Data Management tasks
• Apply new thought processes to daily work
• Expand your expertise

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: CRF Design, CRF Tracking and Communication of Data Trends, Data Query Processing and Tracking

Target Audience: Clinical Data Managers, Data Management Department Heads, Clinical Programmers

Monday, September 24 | 01:45 PM – 03:15 PM

Location: Regency Ballroom A-D, Second Floor

Category: eConsent

Panel Discussion

ESOURCE IMPLEMENTATION AT ACADEMIC AND INDUSTRY-SPONSOR SITES

The session will focus on implementation and real-world examples from the varying perspectives of: academia, biopharmaceutical firms, technology vendors, and US FDA.

Session Chair:

• Michael Buckley, MS, MBA, Manager, Enterprise Innovation, Clinical Research Information and Technology, Clinical Research Administration, MSKCC.
• Rakesh Maniar, Novartis

 Speakers:

• Tesheia H. Johnson, Yale
• Hugh Dai, MD, Eli Lilly
• Shannon Roznoski, BS, CCDM, Director, Product Management, Forte

 Learning Objectives:

• What is eSource?
• Examples of eSource transfers currently in production
• How can I apply eSource to my clinical trials?
• What is the future of eSource?

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Electronic Data Collection, Data Management Plans, Processing Local Lab Data

Target Audience: Data Management, Programmers, Administrators

Monday, September 24 | 01:45 PM – 03:15 PM

Location: Evergreen Ballroom, Lobby Level

Category: Tech

Panel Discussion

DATA MANAGEMENT IN THE WORLD OF ‘DIRECT TO PATIENT’ OR ‘VIRTUAL TRIALS’

Data Management in the world of ‘Direct to Patient’ or ‘Virtual Trials’ Clinical Research has come a long way since using paper in the 1990s. Most studies have adopted electronic solutions with rapid improvements in connectivity and wide availability of clinical technology solutions. Continued enhancements in technology and expansion of clinical research industry in emerging countries and in established geographies are triggering newer models for clinical trials.

Direct to patient or virtual studies allow inclusion of patients without proximity to a specific site or location. This patient centric approach puts patients rather than the trial site at the center of the process. The design of the study as well as the conduct of these studies ensure their patient centricity. Instead of a patient going to a site for the clinical trial, the clinical trial comes to the patient’s home. Patient recruitment, enrolment, engagement and retention, data collection including its management and follow ups are all usually managed from a central office and are supported by staff at regional or local hubs. This new model creates opportunities for new way of collecting and managing trial and operational data. Very limited or zero onsite monitoring creates new challenges in cleaning the clinical trial data.

In this session, we will discuss:

• Latest developments, benefits and challenges of virtual trials
• Enhanced role of Data Managers in ‘Direct to Patient’ clinical trials
• Solutions and strategies for data collection & cleaning
• EDC, ePRO, Medical Devices, Mobile Apps and Operational Data Collection
• Patients driven data generation
• Data security and privacy
• Future trends

 Session Chair: Arshad Mohammed, MBBS, Senior Director, CDM, IQVIA

 Speakers:

• Bruce Hellman, BSc, MBA, CEO, uMotif
• Debra Harris, BA, Associate Director, Pragmatic Health System Research, Duke Clinical Research Institute
• Appalla Venkataprabhakar, MSc, MPhil, PhD, Group Head, Clinical Database Delivery, Novartis Healthcare
• Jonathan Andrus, BA, MS, CCDM, CQA, COO and Data Officer, Clinical Ink, Inc.
• Josh Rose, VP Strategic Planning, IQVIA
• Michelle Longmire, CEO, Medable

 Learning Objectives:

• Attendees will appreciate the evolution of clinical trial processes due to developments in technology solutions for clinical research from Protocol design all the way to Submissions
• Attendees will get a preview of a new model of conducting clinical trials namely: Virtual Clinical Trials or Direct to Patient Clinical Trials. The will also understand the technology framework required and its impact on data management
• Attendees will be able to describe advances in clinical trial technology solutions that enable virtual clinical trials and utilize such solutions and approach to clinical trials in their organizations. We will also focus on Data Management in such trials and attendees will understand any changes in approach needed to plan and execute DM services for such trials

 Session Level: Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience

CDM Certification Competencies: Electronic Data Collection, CFR Tracking and Communication of Data Trends, Clinical Trials Processes, Roles, and Responsibilities

Target Audience: Data Managers, Project Managers, Clinical Programmers

Tuesday, September 25 | 12:30 PM – 01:15 PM

Protocol First – Product Showcase Room 1

For decades, integration between EHR and EDC systems has been seen as the “holy grail” to optimize clinical research. Finally, key technologies and standards are now making such integration a reality. The presenter will explain how SMART and FHIR on the EHR side and CDISC CDASH and ODM on the EDC side allow for integration — without protocol-specific custom coding. The speaker will describe the solution developed by Clinical Pipe and implemented successfully in oncology clinical trials across multiple academic clinical trial centers. Clinical Pipe can integrate with any SMART on FHIR EHR system and connect to any EDC system with a real time API. As of July 2018, the application integrates the 4 leading EHR systems and export data in real time to Medidata Rave and Protocol First EDC. The speaker will also address downstream operational impacts of acquiring data “automatically” from the EHR.

Medidata – Product Showcase Room 2

Beyond eConsent: How a Unified Platform can simplify and streamline Clinical Development with a Patient Centric Approach

Abstract: Adopting an eConsent solution comes with many benefits by itself, less burden on patients and sites, improved learning and retention of trial information and better overall patient retention. But more benefits are unlocked when eConsent is used in conjunction with a platform that allows patient data to seamlessly flow into RTSM and EDC capabilities.

Join us for this live demonstration to learn how Medidata platform streamlines the patient experience while reducing study timelines by allowing patients to enroll electronically, automatically triggering randomization and kit procurement, so patients can fully participate in the trial from in their initial visit.

Tuesday, September 25 | 10:30 AM – 11:15 AM

Veeva – Product Showcase Room 1

Built on a modern unified clinical platform, Veeva Vault EDC allows you to run the trial you want, not the trial your technology limits you to. Quickly deploy studies in weeks, not months, and make in-flight amendments without migrations or downtime. The ability to integrate and maintain complete and concurrent trial data, including non-CRF data, provides real-time insights and dramatically improves productivity.

IBM Clinical Development – Product Showcase Room 2

IBM Clinical Development is a unified solution positioned to Transform the Clinical Trial industry by leveraging cognitive capabilities, data assets, IoT and EMR/EDC integrations. Designed to optimize protocol development, enhance patient/site recruitment and digitize clinical trial processes; IBM Clinical Development can help reduce the time and cost of clinical trials and help life science organizations bring therapies to market faster to benefit patients.

Monday, September 24 | 12:45 PM – 01:30 PM

Covance – Product Showcase Room 1

The hallmark of Covance’s FSPx delivery engine is our focus on innovation, powered by our ability to deliver unique technology-based assets that assist in adding value to our customers. In our relentless pursuit to provide best-in-class services, we bring customized technology assets that enhance our customer experience.

These applications are powered by our Innovation Centre of Excellence, which has continuously delivered tools and frameworks that drive measurable operational improvements. Some of the key initiatives taken up by this CoE are related to EDC Accelerators, Test Data Simulation, and Statistical Programming Workflow as well as advancements in Reporting & Analytics.

OmniComm – Product Showcase Room 2

Clinical Data at Your Fingertips: Using Modern Browser Techniques to Streamline Data Management

Browser technology has evolved since the early days of developing web based EDC, for example the introduction of HTML5. Standards have also been developed and adopted to provide a more consistent and intuitive user experience across web sites. Our demo will show how we have incorporated these into a modern UI for Data Management.

Tuesday, September 25 | 05:00 PM – 06:00 PM

Location: Cedar Ballroom, Second Floor

Category: Career Development & Leadership

FROM DATA MANAGEMENT TO DATA SCIENCE: RAISING THE BAR FOR SCIENTIFIC ABSTRACTS AND PRESENTATIONS

As the field of clinical data management transitions from one of operations to a bona fide scientific subspecialty, the profession’s scientific base will also need to evolve.  The purpose of this session will be to share ideas and provide recommendations for strengthening the scientific rigor of abstracts submitted for possible presentation at the SCDM annual conference.  This ‘how to’ session will include examples and recommendations for practice, including principles that will increase an abstract’s chances for acceptance and be generalizable to other data science conferences, as well.

Session Chair:

• Richard F. Ittenbach, Professor of Pediatrics, Cincinnati Children’s Hospital Medical Center

Speakers:

• Alexander Bragat, Director, Clinical Research DataCore, NYU Langone Medical Center
• Richard F. Ittenbach, Professor of Pediatrics, Cincinnati Children’s Hospital Medical Center

Wednesday, September 26 | 10:30 AM – 12:00 PM

Location: Cedar Ballroom, Second Floor

Category: Tech

Presentation
FROM SPREADSHEETS TO ARTIFICIAL INTELLIGENCE: HOW DO WE GET FROM HERE TO THERE?
With aspects of clinical research seeing rapid expansion into more automated and advanced approaches to day-to-day work tasks, clinical data management is nearing a required adoption of more sophisticated methods of mining study metadata, identifying and cleaning anomalous data, and working with a wider variety of available data sources beyond the traditional electronic data capture (EDC) system model, including EMR/EHR systems. As clinical trials continue to move toward the use of ePRO, wearable technology, and biosensors for data collection, data volume and data velocity will likely render non-algorithm based approaches to data cleaning and error identification obsolete. Deep learning, predictive analytic and machine learning algorithms will become commonplace tools available to clinical data management to expedite and, in some cases, eliminate tasks that have traditionally been handled manually. In addition to the standard arena of clinical data, there are a number of non-traditional areas in which clinical data management is likely to expand. That being said, there is a salient concern that Data Management as it exists today will not have a place in the clinical research enterprise in a future potentially dominated by AI applications. In order to keep up with current trends and remain relevant, those in clinical data management positions must be ready to adapt to the rapidly-changing landscape. This session will be description of the gap between the current state of our industry and where we are likely to find ourselves in the near future based on the evolution of data systems and technology. In addition, we will attempt to paint a clear and actionable path to improving our skill set for those in Data Management today.

Session Chair: Derek Lawrence, BA, Operational Service Lead, Data Management, Rho, Inc.

Speakers:

• Scaling Data Cleaning Through Automation, Statistics, and Data Visualization
  David Hall 

• From Spreadsheets to Artificial Intelligence: How Do We Get from Here to There?
  Charlotte D’souza, MS, Senior Medical Coder, Syneos Health 

• When Artificial Intelligence Meets Clinical Data Management
  Sunil Agarwal

Learning Objectives:

• Learn about the current state of the Data Management role across industries
• Describe the challenges the DM role will face with the adoption of new technologies
• Discuss the potential benefits from advances in technology & tools may have on our industry
• Outline opportunities for those currently in DM roles to evolve & expand their individual capabilities

Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies: Clinical Trials Processes, Roles, and Responsibilities, Processing External Data, Data Query Processing and Tracking

Target Audience: Clinical Data Manager, Statistical Programmer, Statistician

Tuesday, September 25 | 01:30 PM – 03:00 PM

Location: Regency Ballroom E-G, Second Floor

Category: Tech

Presentation

MACHINE LEARNING, ARTIFICIAL INTELLIGENCE IN DATA MANAGEMENT

With an exponential growth of data in recent times & rapid advancements happening on technology front, the need of hour is to generate insights from this massive amount of data. These emerging technologies help to improve the quality of data that we collect and enable us to take informed decisions. Artificial Intelligence (AI) is the ability of a computer or machine to simulate human intelligence, such as visual perception, speech recognition, decision-making, and translation between languages, while Machine learning (ML) may be simply defined as a compilation of algorithmic techniques that can be used to identify patterns to enable or automate decision-making activity. As an example, Natural Language Processing (NLP) can be used to ‘read’ free text in CRFs & assist in scientific review of data. Large data sets from past clinical programs can ‘train’ the ML algorithm and can then be used for subsequent data review, cleaning and analysis. NLP can also help with describing relationships between medically coded terms. Some of the following themes that could be put into practice:

• Pre-programmed therapeutic area based data checks in Clinical Data Repository for additional data review at a Program Level
• Deploy machines to learn from ongoing studies. Utilize this machine learning to enhance the data checks on an ongoing basis, that in turn improves data review across studies in a Program
• Usage of Machine Learning algorithm in Safety Data Management
• Predictive analytics using safety data from ongoing studies to predict adverse events
• Enhance auto-coding using compiled data from multiple studies to enhance the percentage of auto-coded terms
• ML based site performance information on query response times and suggestions for action during clinical monitoring. We intend to focus on practical applications and case studies of these emerging technologies in clinical research space during this session

Session Chair: Appalla Venkataprabhakar, MSc, MPhil, PhD, Group Head, Clinical Database Delivery, Novartis Healthcare

Speakers:

• Case Study: Application of ML/AI in Clinical Data Managemen
  Venkat Sethuraman, PhD, MBA, Global Clinical Lead, R&D Excellence Practice, ZS Associates
  Abhay Jha, MS, Global Technology Lead, R&D Excellence, ZS Associates 
• Applying Machine Learning Techniques for Predictive Analytics in Clinical Data Management
  Yashpalsinh Raj, MS, Senior Clinical Data Analyst, Parexel International 
• Levering AI: Potential Applications in Data Monitoring and Management
  Lynne Cesario, MBA, Global Risk Based Monitoring Program Lead, Pfizer

Learning Objectives:

• Automated anomaly detection during clinical data review augmented through Machine Learning – Case Study
• Case Study around automated clinical data mapping to CDISC standards
• Applying Machine Learning Technique to predict disease outcome based on the data entered in Case Report Form. Eg: Overall Tumor Response
• Quick wins using RPA (Robotic Process Automation) – Case Studies, Long term goals of strategic foundational AI projects like automating generating of specs for elements such as CRF, Edit Checks, Completion Guidelines by leveraging historical experience
• Prediction of Adverse Events based on Lab Safety Data
• Enhance auto-coding using compiled data from multiple studies to increase the number of auto coded terms

Session Level: Expert – Assumes advanced understanding of CDM industry; 6+ years’ experience

CDM Certification Competencies: Coding Medications, CRF Tracking and Communication of Data Trends, Data Query Processing and Tracking

Target Audience: Study Data Manager, Data Team Lead, Data Analyst

Wednesday, September 26 | 10:30 AM – 12:00 PM

Location: Regency Ballroom E-G, Second Floor

Category: RBM

Presentation
ENABLING SMART CENTRAL MONITORING OPEATIONS – TRANSITIONING FROM DATA NOISE TO MEANINGFUL SIGNALS IN RBM

Central monitoring is one of the key pillars of implementing ICH-E6(R2) compliance. Currently, central monitoring approaches at organizations varies from simple and manual review of site level key risk indicators and performance indicators to holistic clinical review of subjects sites and utilizing data-driven automated technology for site risk scoring. The approach utilized for central monitoring is dependent on various factors like availability of skilled resources, appetite for relying heavily on data driven processes, type of technology utilized and maturity of operations.

This session will discuss process framework and technologies utilized for central monitoring in different type and size of organizations. It will focus on:

• Explaining different approaches utilized for identifying and measuring risks
• Illustrations of actionable insights using risk-based monitoring approaches, leveraging data visualizations and custom analytics
• Discuss approaches being used to reduce noise from data-driven methodologies and establish meaningful risk signal detection
• Sharing practical benefits and challenges of utilizing data-driven approaches and technology while implementing centralized monitoring

The session will include 3 speakers (including session chair) with experience and expertise in central data monitoring and clinical analytics.

Session Chair: Abby Abraham, Vice President – Data analytics and RBM, OmniComm Systems Inc.

Speakers:

• Improving Monitoring by Enhancing Signals – Case Study Using Analytics and Risk Scoring Framework
  Abby Abraham, Vice President – Data Analytics and RBM, OmniComm Systems Inc. 

• Risk Based Monitoring: A Joint Focus on Meaningful Risk Signal Detection and a Process for Action
  Erin Reynolds, MS, Operations Data Analyst, AbbVie 

• Risk Based Study Management: A Framework for Guarding Our Data Assets
  Jason Peters, MS, Senior Manager and Development Head, Global Data Management, LivaNova

Learning Objectives:

• Understand how different approaches of implementing risk-based approaches to monitoring and central monitoring can be applied based on organization type
• Learn application of data visualizations and analytics for central monitoring
• Understand the importance of refining alerts into meaningful data signals
• Learn the challenges in implementing central monitoring and how teams adapt to overcome challenges

Session Level: Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience

CDM Certification Competencies: Data Management Plans, Electronic Data Collection, Clinical Database

Target Audience: Study Data Manager, Central Monitor, DM Management

Monday, September 24 | 04:00 PM – 05:30 PM

Location: Regency Ballroom E-G, Second Floor

Category: Niche

Round Table

THERAPEUTIC AREA KNOWLEDGE IN CLINICAL DATA MANAGEMENT: SETTING EXPECTATIONS

The landscape for data managers have changed drastically from the past. From earlier days when a data manager would be doing data entry, make a database and send queries to site, the data manager now has many stakeholders like statisticians, medical writers, preclinical scientists, study responsible physician, medical monitors to name some. There is an expectation from data managers to borne skills which can bridge gap between technical and scientific information and deliver a complete package.

It is increasingly becoming important for data manager understand the impact of data he / she is handling on the overall analysis. This expectation requires a person to understand not only data management as well as SDTM; but also, an understanding of how the drug functions and why a particular parameter can become very important for overall efficacy of the drug. Very often there are expectations that a data manager should have experience in a particular therapeutic area.

While technical skills and soft skills of data managers are being discussed, very little is being talked about the therapeutic area knowledge requirements of a data manager in terms of; what exactly is required, an understanding of assessments in a particular TA or also theoretical knowledge? Is this a necessity and what are the value adds? And most importantly, how to develop TA knowledge of data managers? This session aims to look at the concept of virtual trials and patient centric research through the eyes of a data manager. We’ll look at how using eSource and patient dashboards will challenge the traditional role and tools of a data manager.

This session will involve following discussions:

• Expectations from a data manager on therapeutic area knowledge
• Value add of TA knowledge of a data manager to the trial
• Is it a necessity for all trials or only for some complex trials?
• How to develop TA knowledge of data managers?

Session Chair: Swati Tare, PhD, MSc, BSc, Senior Manager, CDM, Tata Consultancy Services                                                                                                                                                                                      

Speakers:

• Hui (Tanya) Sun,, MA, PhD, PMP, Principal Lead Data Manager, PRA Health Sciences
• Lisa Squibb,D., Sr. Associate Director CDM, Boehringer-Ingelheim Pharmaceuticals, Inc.
• Maria Fernanda V. da Silva, PhD, Clinical Data Management Associate II, Gilead Sciences
• Rebecca Loding, BS, Manager, Data Sciences, Sarah Cannon Development Innovations

 Learning Objectives:

Session Level: Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience

CDM Certification Competencies:

Target Audience:

Monday, September 24 | 09:15 AM – 10:30 AM

LEADERSHIP FORUM

Location: Evergreen Ballroom, Lobby Level

KEYNOTE PRESENTATION
GLOBAL HEALTH CLINICAL TRIALS: CHALLENGING WORK IN CHALLENGING SITUATIONS

Steven E. Kern, Ph.D., Deputy Director, Quantitative Sciences, Global Health – Integrated Development, Bill and Melinda Gates Foundation

The Bill & Melinda Gates Foundation supports partner organizations that conduct high quality clinical and epidemiological trials in challenging locations throughout the world, oftentimes under challenging situations. Regardless, the need for collecting quality data even in the most trying situations is no different than for any other trial. In this keynote, Mr. Kern will highlight some of the approaches the Bill & Melinda Gates Foundation have advanced with their partners to do this important work that impacts the lives of so many in the world.

Keynote Title : Global Health Clinical Trials: Challenging Work in Challenging Situations

The Bill & Melinda Gates Foundation supports partner organizations that conduct high quality clinical and epidemiological trials in challenging locations throughout the world, often times under challenging situations. Regardless, the need for collecting quality data even in the most trying situations is no different than for any other trial. In this keynote, Mr Kern will highlight some of the approaches the Bill & Melinda Gates Foundation have advanced with their partners to do this important work that impacts the lives of so many in the world.

Steven E. Kern, PhD  is Deputy Director of Quantitative Sciences at the Bill and Melinda Gates Foundation. Visit the Keynote Speaker page for more details.