Sunday, September 29

7:00 AM - 8:00 AM


8:00 AM - 12:00 PM

    In this first part of this session PwC will provide educational introduction to several automation technologies, including robotics process automation (RPA), machine learning (ML), and artificial intelligence (AI). We will describe the individual characteristics of each technology, including strengths and limitations, as well as practical uses of these technologies. In the second... Read More

    Session Chairs & Speakers

    Ian Shafer
    PricewaterhouseCoopers
    Topic
    • Workshop

    9:00 AM - 4:00 PM

      As our industry continues to evolve, we are seeing a much greater focus on digital technologies, direct patient engagement, and unique methods to collect and analyze clinical data. Many newcomers to the Data Management community bring a broad skill set in data analytics, mobile technology knowledge, and data science methodologies... Read More

      Session Chairs & Speakers

      Derek Perrin
      Executive Director, Data Management
      Astellas Pharma
      Meg Richie
      Vice President, Global FSP Operations
      Clinipace
      • Expert

      1:00 PM - 5:00 PM

        Requirements exist for the submission of standardized electronic study data to the FDA.  This workshop will summarize the regulatory basis for submitting such data, provide an overview of the standards that govern such submissions, and discuss the additional support files necessary for a complete submission....

        Session Chairs & Speakers

        Frederick Wood
        Jr., Ph.D, Vice President
        Data Standards Consulting Group
        Topic
        • Workshop

        5:00 PM - 6:00 PM

          SCDM is made possible thanks to well driven and enthusiastic members and volunteers. Do you want to be part of a thriving professional network and make an impact on your profession? Don't miss the opportunity to attend the SCDM Volunteer Happy Hour, on Sunday, September 29 from 05:00 to 06:00 PM.... Read More
          • Social Event

          6:00 PM - 8:00 PM

            Are you ready for #SCDM2019? Let's kick-off in the right way. The Annual Conference welcomes all attendees to the Opening Reception. Meet the top industry leaders and sponsors during this exceptional networking opportunity, while enjoying a bubbling drink and some nibbles. The reception will start at 06:00 PM. Be there... Read More
            • Social Event

            Monday, September 30

            7:00 AM - 7:45 AM

              For our 25th Anniversary, we want to keep our community young and fresh, let’s make this happen! Join us for a revitalizing run/ walk before a productive and amazing first day at the SCDM Annual Conference. Registration for this event is free, but we encourage all of you to participate... Read More
              • Social Event

              7:30 AM - 8:30 AM


              7:30 AM - 6:15 PM


              8:30 AM - 10:30 AM

                AGENDA: Welcome Address  SCDM Business Meeting  Keynote Presentation: RE-Defining, RE-Imagining and RE-Engineering the drug development paradigmthough the lens of Real World Data, Patient Level Data, Machine Learning and Artificial Intelligence. Description:  The discussion will focus on the premise that the current drug development and clinical trial paradigm is highly inefficient and has resulted in time... Read More

                Session Chairs & Speakers

                Kent Thoelke
                Chief Scientific Officer and Executive Vice President
                PRA Health Sciences
                Topic
                • Plenary Session

                10:30 AM - 11:15 AM


                11:15 AM - 12:15 PM

                  This is an exciting time to be a part of clinical data management. Technology continues to advance at a rapid pace and the way that we perform our jobs is changing right before our eyes. This presentation will explore 3 areas where technology will have the greatest impact and take... Read More

                  Session Chairs & Speakers

                  Topic
                  • Intermediate
                  • Oral Presentation
                    The data sources in the Clinical Trials is growing, in numbers, volume of data, as well as diversified technologies being used. More and more trials are using real-world data and data collected from devices, mHealth, smart phones etc. Some studies indicate that average number of data sources per trial is... Read More

                    Session Chairs & Speakers

                    Topic
                    • Advanced
                    • Panel Discussion
                      In this session we will discuss, how Artificial Intelligence will transform Clinical Data Management. Human versus machine battle has already started in other industries. How can we leverage machines to do not just repetitive data cleaning tasks but take on higher complexity tasks in tandem with humans. AI is not... Read More

                      Session Chairs & Speakers

                      Topic
                      • Expert
                      • Oral Presentation
                        Presentations should share a personal experience and focus on a solution your company developed (or is developing) to solve a specific challenge CDMs are facing. The main objective is to take the audience on a journey and inspire them while showcasing your company’s contribution to the advancement of the industry.... Read More

                        Session Chairs & Speakers

                        Topic
                        • Intermediate
                        • Ignite Presentation

                        12:15 PM - 1:45 PM


                        12:30 PM - 1:15 PM


                        1:45 PM - 3:15 PM

                          Developing Industry Best Practices and Metrics for data from wearables, apps and sensors. The almost daily emergence of another data generating device such as an App, sensor or wearable and its potential use in clinical trials is raising some interesting questions about the role of traditional Data Management and therefore the... Read More

                          Session Chairs & Speakers

                          Topic
                          • Advanced Expert
                          • Oral Presentation
                            As clinical trials grow in complexity, data management and data science are tasked to manage and make insight from continuous data collection and an exploding variety of data sources. The case for Artificial Intelligence and Machine Learning applications in clinical data is clear – but where are the practical applications... Read More

                            Session Chairs & Speakers

                            Topic
                            • Advanced
                            • Panel Discussion
                              Zero-Site clinical trials - trials conducted limiting or eliminating the need to make patients recruited at Sites also known as “Virtual Trial”. These are a relatively new method of conducting a clinical trial to collect data on the safety and efficacy of a molecule or medical device leveraging technology (apps,... Read More

                              Session Chairs & Speakers

                              Topic
                              • Advanced Expert
                              • Oral Presentation
                                In the last decade, digital technologies have transformed every aspect of clinical research. The use of eSource in data collection highlights the importance of data integrity more than ever.  While the traditional approaches of GDP (Good Documentation Practices) and ALCOA (attributable, legible, contemporaneous, original and accurate) are applicable to eSource,... Read More

                                Session Chairs & Speakers

                                Topic
                                • Intermediate
                                • Oral Presentation


                                4:00 PM - 5:00 PM

                                  I propose a round table session creating a rare opportunity for attendees to get face time with senior industry leaders. Each leader will be from a different sector of the industry (CRO, Pharma/Biotech, Technology, Manufacturing or Supply, Software, Technology, etc.) and will come prepared to offer their thoughts on how... Read More

                                  Session Chairs & Speakers

                                  Kelly Ritch
                                  MedNet Solutions
                                  Topic
                                  • Intermediate
                                  • Roundtable Discussion

                                  4:00 PM - 5:30 PM

                                    This panel will discuss what a virtual trial is, what potential virtual trial data sources are, and the pros and cons that should be considered when working through trial start-up.  We will use real examples, sharing risks, mitigations, successes and lessons learned. We will also delve into regulatory/privacy considerations and... Read More

                                    Session Chairs & Speakers

                                    Topic
                                    • Intermediate
                                    • Panel Discussion
                                      This session will be moderated by a Data Management expert but will offer a unique opportunity to gain perspective from a variety of thought leaders within Clinical Operations. Senior leaders will discuss how process, methodology, and technology are breaking down the traditional silos of Data Management and Clinical Operations. Attendees... Read More

                                      Session Chairs & Speakers

                                      Topic
                                      • Intermediate
                                      • Oral Presentation
                                        Clinical development is going through a second wave of transformation. Now that paper processes have been large converted to electronic ones there is an opportunity to further transform R&D organizations to digital enterprises that use data assets in new ways to maximize efficiencies and scientific value. This session will highlight... Read More

                                        Session Chairs & Speakers

                                        Topic
                                        • Intermediate
                                        • Storytelling

                                        5:30 PM - 6:15 PM

                                          • Poster Presentation

                                          Tuesday, October 01

                                          7:15 AM - 8:00 AM


                                          7:15 AM - 6:15 PM


                                          8:00 AM - 9:30 AM

                                            The annual SCDM Regulatory Forum will offer participants an opportunity to engage our panelists from the FDA and EMA 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... Read More

                                            Session Chairs & Speakers

                                            Jean Mulinde
                                            Medical Officer, Senior Policy Advisor Division of Clinical Compliance Evaluation Office of Scientific Investigations, CDER
                                            FDA
                                            Jonathan Andrus
                                            M.S., CQA, CCDM, Chief Business Officer
                                            Clinical Ink, Inc.
                                            Kassa Ayalew
                                            Branch Chief, Office of Scientific Investigations, Office of Compliance, CDER
                                            FDA
                                            Lisbeth Bregnhøj
                                            MSc Pharmacy, PhD, Medicines Inspector, GCP and GVP
                                            Danish Health and Medicines Authority
                                            Ni Aye Khin
                                            Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER
                                            FDA
                                            Topic
                                            • Plenary Session


                                            10:15 AM - 11:15 AM

                                              Data Management has changed in many ways over the years, but have the related process kept up? This panel will pose this question to data managers in a variety of organization to hear how processes differ among organizations. The panel will discuss the handling of protocol deviations, system implementation responsibilities, data... Read More

                                              Session Chairs & Speakers

                                              Topic
                                              • Intermediate
                                              • Panel Discussion
                                                The eSource revolution is no longer on its way. It’s here. Experts are promising big things with eSource, and organizations that have adopted are using it to reduce costs, race their trials forward, and sharpen their competitive edge. This panel discussion will acknowledge the very real concerns of industry players... Read More

                                                Session Chairs & Speakers

                                                Topic
                                                • Intermediate
                                                • Panel Discussion
                                                  When sites are able to seamlessly share data with sponsors using their existing enterprise systems, clinical research gains true efficiencies. There are many efforts underway to promote use of eSource and information exchange between sites and sponsors, and there is a lot to learn from these exciting projects. This session... Read More

                                                  Session Chairs & Speakers

                                                  Topic
                                                  • Intermediate
                                                  • Oral Presentation
                                                    In the context of multicenter clinical research, Centralized Statistical Monitoring (CSM) is the most efficient way to ensure subject’s safety, trial integrity and data quality. As it permits the study team to proactively detect anomalous data trends, CM improves the quality of the regulatory submissions with a direct impact on... Read More

                                                    Session Chairs & Speakers

                                                    Topic
                                                    • Advanced
                                                    • Oral Presentation

                                                    11:30 AM - 12:30 PM

                                                      The new reality of clinical trials is they are always in "startup mode." Teams are challenged to provide high quality data in real time, while flexing to protocol changes and other modifications along the way. Despite this changing landscape, the ultimate goal of a highest quality dataset remains critical. Successful... Read More

                                                      Session Chairs & Speakers

                                                      Topic
                                                      • Intermediate
                                                      • Oral Presentation
                                                        It is clear the work in Data Management is changing rapidly due to evolving science, technology and innovation. In this panel discussion, attendees will receive advice from Leaders in Data Management from diverse backgrounds and companies. These leaders will discuss ways in which attendees can expand their knowledge and skills... Read More

                                                        Session Chairs & Speakers

                                                        Topic
                                                        • Intermediate
                                                        • Panel Discussion
                                                          Well before any efficacy or safety results become available, data managers are awash in operational data. The statuses of site activation, screening and enrollment rates, turnaround times for data entry and query closure, missed visits, adverse events, SDV tracking, payments -- these are just a few of the dimensions along... Read More

                                                          Session Chairs & Speakers

                                                          Topic
                                                          • Intermediate
                                                          • Panel Discussion
                                                            This innovative session will consist of 6-8 presentations on a diversity of sujects and will be kicked off by 2-3 minutes (2 slides) elevator pitches highliting the key elements of each topic/ presentation to the entire audience. Following the pitches,each presenter will be assigned a table for a more in-depth,... Read More

                                                            Session Chairs & Speakers

                                                            Topic
                                                            • Intermediate
                                                            • Ignite Presentation

                                                            12:30 PM - 1:30 PM


                                                            12:45 PM - 1:30 PM


                                                            1:30 PM - 3:00 PM

                                                              The patient-centered trial introduces many more sources of data, including eConsent, patient diaries and mHealth devices. This has to be pooled with the classic sources of data, including site-entered information, lab results and imaging data. Where should all that data be collected for analysis? If it goes straight into a... Read More

                                                              Session Chairs & Speakers

                                                              Topic
                                                              • Advanced
                                                              • Oral Presentation
                                                                Following on from 2018, this session will explore the topics most likely impact data management in the next five years. Using a format similar to the FREAKONOMICS "Tell me something I do not know," speakers will have just 12 minutes to present their topic and convince the audience that their... Read More

                                                                Session Chairs & Speakers

                                                                Topic
                                                                • Advanced
                                                                • Ignite Presentation
                                                                  An overwhelming amount of data in a highly dynamic regulatory environment might leave one with the feeling of being stuck in the weeds. This group of experts will share their knowledge to help you work smarter and more strategically with the use of Artificial Intelligence, Strategic Data Analysis and Data... Read More

                                                                  Session Chairs & Speakers

                                                                  Topic
                                                                  • Advanced
                                                                  • Oral Presentation

                                                                    Session Chairs & Speakers

                                                                    Topic
                                                                    • Intermediate
                                                                    • Workshop



                                                                    3:30 PM - 5:00 PM

                                                                      A patient-centric approach is a way healthcare systems can establish a partnership among the clinical trial stakeholders including patients and their families by identifying and addressing patients’ needs, and preferences. With the evolving landscape, new concepts of patient connectivity are emerging, and digital health is rapidly gaining popularity and importance... Read More

                                                                      Session Chairs & Speakers

                                                                      Topic
                                                                      • Advanced Expert
                                                                      • Panel Discussion
                                                                        Risk-based monitoring (RBM) has steadily evolved over the last seven years. Large organizations are beginning to achieve process maturity in implementing RBM on studies. It is also recognized that the quality of key risk indicators (KRI) and contextual application of the same will expand and improve in the industry in... Read More

                                                                        Session Chairs & Speakers

                                                                        Topic
                                                                        • Advanced
                                                                        • Oral Presentation
                                                                          Interim Analyses typically require a sub-set of data to be “clean”, and are often executed multiple times through the duration of a Clinical Trial.  In fact, Interim Analyses or Submissions are often times the most critical provision of a Clinical Trial, for “Go/No-Go” decisions, or key efficacy endpoint analyses.   Cleaning... Read More

                                                                          Session Chairs & Speakers

                                                                          Topic
                                                                          • Advanced
                                                                          • Panel Discussion

                                                                          4:45 PM - 6:15 PM

                                                                            Session Chairs & Speakers

                                                                            Meredith Zozus
                                                                            Ph.D., CCDM Associate Professor and Vice Chair for Academic Programs
                                                                            University of Arkansas for Medical Sciences
                                                                            Topic

                                                                              5:15 PM - 6:15 PM

                                                                                In recent years much has been discussed and written about Real World Data (RWD) and Real World Evidence (RWE). What is RWD and RWE?  Why we need it? and How to utilize it for everyone’s benefit? RWD is the foundation of RWE while RWE is a new way of bridging... Read More

                                                                                Session Chairs & Speakers

                                                                                Topic
                                                                                • Expert
                                                                                • Panel Discussion
                                                                                  While this era of digital disruption could increase volatility, it also creates new opportunities for those who are ready to embrace the change. The confluence of digital technologies - social, mobile, analytics & cloud with emerging technologies such as AI, IoT, AR, VR and now block chain has opened myriad... Read More

                                                                                  Session Chairs & Speakers

                                                                                  Topic
                                                                                  • Advanced Expert
                                                                                  • Panel Discussion

                                                                                  7:30 PM - 9:30 PM

                                                                                    • Social Event

                                                                                    Wednesday, October 02

                                                                                    7:30 AM - 8:30 AM


                                                                                    7:30 AM - 12:00 PM


                                                                                    8:30 AM - 10:00 AM

                                                                                      AGENDA: Panel of Experts Award Ceremony ...

                                                                                      Session Chairs & Speakers

                                                                                      Demetris Zambas
                                                                                      VP and Global Head of Data Monitoring and Management
                                                                                      Pfizer
                                                                                      Topic
                                                                                      • Plenary Session

                                                                                      10:00 AM - 10:30 AM


                                                                                      10:30 AM - 12:00 PM

                                                                                        eSource is scaling the Garner hype cycle with great strides. Many organizations/companies are currently conducting pilots, scaling to production, and creating partnerships/collaborators. The solution for eSource will require the active cooperation and participation of all stakeholders. The regulatory agencies are demonstrating interest with the recent ONC/CMS proposed rule, EMA guidance,... Read More

                                                                                        Session Chairs & Speakers

                                                                                        Topic
                                                                                        • Advanced
                                                                                        • Roundtable Discussion
                                                                                          Risk Based Study Execution - How we are taking our project teams and clients past Risk Based Monitoring.  The industry is slowly realizing it's not just about the "monitoring" and that all functions need to be involved in assessing and managing risks on our clinical studies. We have implemented a... Read More

                                                                                          Session Chairs & Speakers

                                                                                          Topic
                                                                                          • Intermediate
                                                                                          • Storytelling
                                                                                            A variety of health and medical data is the standard resource for most clinical research. This data is either collected during the course of ongoing patient care or as part of a formal clinical trial program. These variety of sources could be:    Electronic health records  Central Labs  Diagnostic and Imaging ... Read More

                                                                                            Session Chairs & Speakers

                                                                                            Topic
                                                                                            • Expert
                                                                                            • Panel Discussion
                                                                                              There is a paradigm shift in how data is being captured for clinical research. Patients are demanding a move away from a time heavy model involving site visits, interviews and manual data collection. This is the shift to digital assessments and is often viewed through the prism of eCOA and... Read More

                                                                                              Session Chairs & Speakers

                                                                                              Topic
                                                                                              • Advanced
                                                                                              • Oral Presentation