Sunday, September 29

7:00 AM - 8:00 AM

Registration
  • Room: Harborside Ballroom Foyer

    8:00 AM - 12:00 PM

    Pre-Conference Workshop 1 - A Design Thinking Approach to Exploring Automation Technologies in Clinical Development Operations
    • Room: Laurel CD
    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
    Partner
    PricewaterhouseCoopers
    • Workshop

    9:00 AM - 4:00 PM

    Leadership Forum - Identifying and Engaging the Next Generation of Clinical Data Management Leaders
    • Room: Laurel AB
    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
    Jean Mulinde
    Division of Clinical Compliance Evaluation
    CDER, FDA
    Kassa Ayalew
    Supervisory Medical Officer/Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation, CDER
    FDA
    Lisbeth Bregnhøj
    MSc Pharmacy, PhD, Medicines Inspector, GCP and GVP
    Danish Medicines Agency
    Meg Richie
    Vice President, Global FSP Operations
    Atorus Research
    Ni Aye Khin
    Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER
    FDA
    Patrick Nadolny
    Associate VP, Clinical Data Management and Programming
    Allergan
    • Expert

    1:00 PM - 5:00 PM

    Pre-Conference Workshop 2 - Preparing Data for a Regulatory Submission
    • Room: Laurel CD
    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
    • Workshop

    5:00 PM - 6:00 PM

    SCDM Volunteer Happy Hour
    • Room: Waterview Ballroom AB
    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. This... Read More
    • Networking

    6:00 PM - 8:00 PM

    Opening Reception
    • Room: Harborside Ballroom, Foyer & Kent
    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 on time!... Read More
    • Networking

    Monday, September 30

    7:00 AM - 7:45 AM

    SCDM Run/ Walk
      ''A RUN A DAY KEEPS THE DOCTOR AWAY'' 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... Read More
      • Networking

      7:30 AM - 8:30 AM

      Breakfast
      • Room: Grand Ballroom Foyer
      Sponsored by

        7:30 AM - 6:00 PM

        Registration
        • Room: Harborside Ballroom Foyer

          8:30 AM - 10:30 AM

          SCDM Business Meeting & Keynote Presentation
          • Room: Grand Ballroom V-VI
          AGENDA: Welcome Address SCDM Business Meeting: ​An annual general meeting of the general membership of SCDM. Whereby Members are informed on the society’s progress and given the opportunity to approve key decisions as required by the bylaws. Everyone is welcome to the meeting, however only members can vote, if needed. ... Read More

          Session Chairs & Speakers

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

          10:30 AM - 11:15 AM

          Coffee Break & Exhibition
          • Room: Harborside Ballroom, Foyer & Kent
          Sponsored by

            11:15 AM - 12:15 PM

            Session 1 - Clinical Data Management 2022: A Glimpse Into the Future
            • Room: Grand Ballroom VII-X
            Clinical Data Management 2022: A glimpse into the future 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... Read More

            Session Chairs & Speakers

            • Intermediate
            • Oral Presentation
            Session 2 - Beyond EDC: New Opportunities and Challenges with Diversification of Data Sources in Clinical Trials
            • Room: Grand Ballroom V
            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

            • Intermediate
            • Panel Discussion
            Session 3 - Intelligent Machines Take on Clinical Data Management
            • Room: Grand Ballroom VI
            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

            • Expert
            • Oral Presentation
            Session 4 - Technology Ignite - Spark the Future
            • Room: Grand Ballroom I-IV
            This session will be unique in its presentation. We have 5 speakers who will entice you with a brief look into their world. 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.... Read More

            Session Chairs & Speakers

            • Intermediate
            • Ignite Session

            12:15 PM - 1:30 PM

            Product Showcase 1 - Veeva Systems (Shortening Database Builds by 40-60% with Agile Design)
            • Room: Laurel A
            Radical time savings aren’t possible with incremental process improvements. However, inefficient build processes are often the byproduct of EDC limitations. An agile EDC enables process transformation that shortens database builds by 40-60%. Veeva describes the technologies and processes behind those savings, including spec-less design, real-time UAT, and easy amendments....
            Sponsored by

              12:15 PM - 1:45 PM

              Lunch & Exhibition
              • Room: Harborside Ballroom, Foyer & Kent
              Sponsored by

                12:45 PM - 1:30 PM

                Product Showcase 2 - Omnicom Systems (EDC, ePRO, eConsent, eZ: How a unified approach to data collection makes everything easy)
                • Room: Laurel B
                So you want to include ePRO and eConsent into your trials but are concerned about adding two more vendors with the associated cost and complexity? See how OmniComm’s EDC solution can overcome this with a single EDC/eConsent/ePRO capability....
                Sponsored by

                  Product Showcase 3 - IQVIA ( Driving real-time and quality insights through direct-from-patient eCOA data collection to accelerate study timelines and enhance the patient experience)
                  • Room: Laurel C
                  Traditional paper-based patient data collection makes real-time insight very difficult or impossible to gather and understand. There’s a clear need for a more effective and efficient solution. In this session, we will discuss the evolution of electronic clinical outcome assessments (eCOA), highlight how new technologies can strengthen patient data collection, and... Read More
                  Sponsored by

                    1:45 PM - 3:15 PM

                    Session 5 - Developing Industry Best Practices and Metrics for Data from Wearables, Apps and Sensors
                    • Room: Grand Ballroom VII-X
                    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

                    • Advanced Expert
                    • Oral Presentation
                    Session 6 - Artificial Intelligence to Solve Clinical’s “Big Data” Challenges: Practical Today, Predicting Tomorrow
                    • Room: Grand Ballroom V
                    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

                    • Expert
                    • Panel Discussion
                    Session 7 - Hurdles and Promises of Zero-Site Trials – Embracing the Future through the Data Management Lenses
                    • Room: Grand Ballroom VI
                    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

                    • Advanced Expert
                    • Oral Presentation
                    Session 8 - Data Integrity in the Age of eSource
                    • Room: Grand Ballroom I-IV
                    Throughout the last decade, digital technologies have transformed virtually every aspect of clinical research. Increased use of eSource data collection methods have highlighted more than ever before the importance of data integrity in clinical trials. While traditional approaches of GDP (Good Documentation Practices) and ALCOA (attributable, legible, contemporaneous,... Read More

                    Session Chairs & Speakers

                    • Intermediate
                    • Oral Presentation

                    3:15 PM - 4:00 PM

                    Coffee Break & Exhibition
                    • Room: Harborside Ballroom, Foyer & Kent
                    Sponsored by

                      Poster Presentations
                      • Room: Grand Ballroom Foyer
                      POSTER PRESENTATIONS PO01 | Advantage of the Decision of Quality Objectives Required by QMS After Risk Identification/Evaluation, Hidenobu Kondo, Risk-based Monitoring (RBM) Consultant, Tohoku University School of Medicine  PO02 | Evaluation of ECRIN Requirements in ISO 9001 QMS Certification for Clinical Data Center, Munenori Takata, Senior Lecture, Clinical Trial Data Center, Tohoku University Hospital PO03 | The Effectiveness... Read More

                      Session Chairs & Speakers

                      Sponsored by

                      • Poster Presentation
                      Product Showcase 1 - Medrio (Participant-Centric Data Collection)
                      • Room: Laurel A
                      During this session you will learn how Medrio can enable your trials to move toward patient-centric data collection. Our eClinical tools empower Data Managers with the combination of data collected from both patients and trial site staff, as well as labs and other sources. The combination of Medrio EDC, DDC,... Read More
                      Sponsored by

                        Product Showcase 2 - Quartesian (Visualize Site and CRO Performance and Take Control of Your Clinical Study)
                        • Room: Laurel B
                        Clinical trial sponsors are rightfully concerned about losing control of their study and their study data when they outsource. No wonder, since many studies can involve a dozen vendors or more. Getting the right information to track performance and efficiency within a useful time frame can be ‘challenging’. In this... Read More
                        Sponsored by

                          Product Showcase 3 - IBM Watson Health (Advantages of a Unified EDC/CDMS for Study Designers)
                          • Room: Laurel C
                          IBM Clinical Development is a truly unified EDC system where creating a new study environment is easy and doesn't require IT, research and development, and any other barriers that typically hinder speed and efficiency. With IBM, you have access to all of our EDC and eClinical functionality such as ePRO,... Read More
                          Sponsored by

                            4:00 PM - 5:00 PM

                            Session 12 - Career Inspiration and Guidance from the C-suite
                            • Room: Grand Ballroom I-IV
                            This session will explore the career journeys as inspiration for new or mid-level data managers. Speakers that have risen to Senior Positions will tell their stories and share advice on how to grow as a data manager. We will present experiences from the CRO perspective as well as the sponsor... Read More

                            Session Chairs & Speakers

                            Aroba Hafeez
                            Manager, Clinical Data Manager
                            Forty Seven Inc
                            Lisa Levin
                            Manager, Clinical Data Management
                            PRA Health Sciences
                            Ms  Maria Craze
                            Executive Director, Global Data Operations
                            Merck Sharp & Dohme
                            Mr.  Ralph Russo
                            Senior Director
                            Pfizer
                            • Intermediate
                            • Roundtable Discussion

                            4:00 PM - 5:30 PM

                            Session 10 - Getting the Start-up Right for a Virtual Trial – Data Management Insights
                            • Room: Grand Ballroom V
                            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

                            • Intermediate
                            • Panel Discussion
                            Session 11 - The Merging of Data Management and Clinical Operations - Welcome to the Future
                            • Room: Grand Ballroom VI
                            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

                            • Intermediate
                            • Oral Presentation
                            Session 9 - Roadmap to D-Clinical - Designing Your Digital Data Strategy
                            • Room: Grand Ballroom VII-X
                            Developing a digital data strategy is a key imperative for Life Sciences companies as the value of clinical data is increasing along with the breadth and complexity of clinical data sources and data types. This session will share different stories and perspectives about clinical data strategy development, implementation and technology... Read More

                            Session Chairs & Speakers

                            • Intermediate
                            • Storytelling

                            5:30 PM - 6:15 PM

                            Poster Presentations
                            • Room: Grand Ballroom Foyer
                            POSTER PRESENTATIONS PO06 | To Assess Acceptability, and Feasibility of Utilizing the eSource in Comparison with the Traditional EDC Workflow, Yerramalli Subramaniam, CliniOps Inc; PO07 | Improving Patient Engagement with the Electronic Informed Consent (eIC) Platform for Clinical Trials: An Operational Model and Suite of Tools for Consent Authoring, Obtaining Informed Consent, and Managing Consent Documents, Michael... Read More

                            Session Chairs & Speakers

                            Cathleen Jewell
                            PhD, Clinical Analytics Manager in Data Sciences
                            AbbVie
                            Michael Buckley
                            Manager, CRIT Enterprise Innovation
                            Memorial Sloan Kettering Cancer Center
                            Yerramalli Subramaniam
                            CliniOps Inc.
                            Sponsored by

                            • Poster Presentation

                            Tuesday, October 01

                            7:00 AM - 8:00 AM

                            Breakfast
                            • Room: Grand Ballroom Foyer

                              7:00 AM - 6:00 PM

                              Registration
                              • Room: Harborside Ballroom Foyer

                                8:00 AM - 9:30 AM

                                Regulatory Panel
                                • Room: Grand Ballroom V-VI
                                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
                                Division of Clinical Compliance Evaluation
                                CDER, FDA
                                Jonathan Andrus
                                M.S., CQA, CCDM, Chief Business Officer
                                Clinical Ink, Inc.
                                Kassa Ayalew
                                Supervisory Medical Officer/Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation, CDER
                                FDA
                                Lisbeth Bregnhøj
                                MSc Pharmacy, PhD, Medicines Inspector, GCP and GVP
                                Danish Medicines Agency
                                Ni Aye Khin
                                Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER
                                FDA
                                • Plenary Session

                                9:30 AM - 10:15 AM

                                Coffee Break & Exhibition
                                • Room: Harborside Ballroom, Foyer & Kent
                                  Product Showcase 1 - OpenClinica (Better Forms, Better Data)
                                  • Room: Laurel A
                                  If data is the lifeblood of a study, then forms are its arteries. The appearance, behavior, and “intelligence” of your eCRFs may be the greatest determinant of data quality. OpenClinica forms are designed to delight CRCs and participants, prompting accurate and timely entry with the aid of cross-form calculations, sophisticated... Read More
                                  Sponsored by

                                    Product Showcase 4 - eClinical Solutions (Next Generation Data Review Using the elluminate Clinical Data Hub)
                                    • Room: Laurel D
                                    eClinical Solutions will be presenting the elluminate Clinical Data Hub in the product showcase. See how the elluminate platform is a foundational component of a digital data strategy by enabling life sciences companies to regain control of their clinical trial data. All platform modules will be demonstrated including importer which... Read More
                                    Sponsored by

                                      9:30 AM - 10:15 PM

                                      Product Showcase 2 - Ratilan (The Smart Mapper: A Machine Learning Tool for SDTM Mapping)
                                      • Room: Laurel B
                                      Minnal is a Machine Learning platform for Clinical Data and Submissions Management, developed by Ratilan Technologies. The Smart Mapper, which will be showcased today, is one component of Minnal, and uses Machine Learning to automate SDTM Mapping....
                                      Sponsored by

                                        Product Showcase 3 - Medidata (How liquid data takes us beyond Data Management 2.0)
                                        • Room: Laurel C
                                        ..toward a new future: Data Management² Medidata is developing a unified and protocol-aware platform that makes all of your data – irrespective of its source – liquid. The result: you will know exactly when you’re “done,” get to "done" faster, and have full visibility into the journey your data has taken... Read More
                                        Sponsored by

                                          10:15 AM - 11:15 AM

                                          Session 13 - Data Processes - Has Yours Jumped the Shark?
                                          • Room: Grand Ballroom V
                                          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

                                          • Intermediate
                                          • Panel Discussion
                                          Session 14 - Gimmick or Game-Changer? What eSource Really Does to Clinical Trial Costs and Timelines
                                          • Room: Grand Ballroom VI
                                          The eSource revolution is no longer on its way. It’s here. Experts are promising big things with eSource, and notable use cases have emerged demonstrating its impact on costs, timelines, and the competitive landscape in clinical research. In this panel, experienced eSource users will discuss their experience and leverage data... Read More

                                          Session Chairs & Speakers

                                          • Intermediate
                                          • Panel Discussion
                                          Session 15 - Better Together: Three Ways Sites and Sponsors are Collaborating Using eSource and Data Exchange
                                          • Room: Grand Ballroom VII-X
                                          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

                                          • Intermediate
                                          • Oral Presentation
                                          Session 16 - Centralized Statistical Monitoring: New Tools and Implementations for DM Operations
                                          • Room: Grand Ballroom I-IV
                                          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

                                          • Advanced
                                          • Oral Presentation

                                          11:30 AM - 12:30 PM

                                          Session 17 - An Agile Approach to Data Management: Improving the End-to-End Clinical Data Strategy
                                          • Room: Grand Ballroom VII-X
                                          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

                                          • Advanced
                                          • Oral Presentation
                                          Session 18 - Advice from the Experts for the CDM Career for the Future
                                          • Room: Grand Ballroom V
                                          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

                                          • Intermediate
                                          • Panel Discussion
                                          Session 19 - Measuring What Matters: KPIs for Data Quality, Speed, and Cost
                                          • Room: Grand Ballroom VI
                                          This panel session sets out to answer these questions. Attendees will leave the session with specific KPIs for a variety of trial types, from fast-enrolling Phase IIs, where data speed is critical, to large, endpoint-driven Phase IIIs, where patient recruitment largely determines timelines. Specifically, our panel will outline KPIs for: Site... Read More

                                          Session Chairs & Speakers

                                          • Intermediate
                                          • Panel Discussion
                                          Session 20 - Selected Shorts
                                          • Room: Grand Ballroom I-IV
                                          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

                                          • Intermediate
                                          • Ignite Session

                                          12:30 PM - 1:15 PM

                                          Lunch & Exhibition
                                          • Room: Harborside Ballroom, Foyer & Kent
                                            Product Showcase 1 - Decima Software (Dacima Clinical Suite: Tired of having to fit a square peg in a round whole – Dacima takes EDC to a whole new level of study design!)
                                            • Room: Laurel A
                                            Tired of EDCs that limit your design capabilities. Dacima Clinical suite is an advanced cloud EDC platform with integrated modules for IWRS, Supply Management, ePRO, eDiary, medical coding, eConsent and monitoring, that let you go beyond what is possible with traditional EDCs. The system is the most configurable EDC on... Read More
                                            Sponsored by

                                              Product Showcase 2 - Oracle (Streamlined Data Processing Strategies with Emerging Data Sources)
                                              • Room: Laurel B
                                              Clinical data diversity and volume is growing rapidly, leaving traditional clinical trial programming methods unsustainable. Single artifact, duplicate programming is slow, resource intensive, and costly. In this session, learn why many of the top biopharma companies are moving to enterprise clinical data management solutions that focus on centralized aggregation and... Read More
                                              Sponsored by

                                                Product Showcase 3 - Castor (Leveraging the power of standardized data from Wearables eCOA and EHR to pave the way for decentralized trials)
                                                • Room: Laurel C
                                                Patient centric, decentralized trials have many advantages over more traditional trials, but bring their own challenges with regards to both data quality and large volumes of data. In this session we will discuss how standardizing data at the source can allow researchers to leverage the power standardized data to support... Read More
                                                Sponsored by

                                                  Product Showcase 4 - Clinical Pipe (EHR-to-EDC is Finally Here!)
                                                  • Room: Laurel D
                                                  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 ODM on the EDC side... Read More
                                                  Sponsored by

                                                    1:30 PM - 3:00 PM

                                                    Session 21 - In a Patient-Centered Trial, Where Do You Store All That Data?
                                                    • Room: Grand Ballroom V
                                                    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

                                                    • Advanced
                                                    • Oral Presentation
                                                    Session 22 - Tell Me Something I Don’t Know – What Will Change Data Management the Most?
                                                    • Room: Grand Ballroom VI
                                                    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

                                                    • Advanced
                                                    • Ignite Session
                                                    Session 23 - Getting Out of the Weeds - Using AI and Strategic Data Analysis Approaches to Monitor Studies
                                                    • Room: Grand Ballroom VII-X
                                                    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

                                                    • Advanced
                                                    • Oral Presentation
                                                    Session 24 - Pop-Up Session
                                                    • Room: Grand Ballroom I-IV
                                                      Session 25 - Escape the Blind
                                                      • Room: Laurel D
                                                      This workshop will assist attendees in identifying areas of clinical trials that can lead to unblinding. It features a training session, followed by an escape room activity where you will join a clinical project team consisting of zombie apocalypse survivors on a mission to break the blind of a promising... Read More

                                                      Session Chairs & Speakers

                                                      • Intermediate
                                                      • Workshop

                                                      3:00 PM - 3:30 PM

                                                      Coffee Break - Vendor Prize Draw
                                                      • Room: Harborside Ballroom, Foyer & Kent

                                                        3:30 PM - 4:30 PM

                                                        Session 29 - Pop-Up Session
                                                        • Room: Grand Ballroom I-IV

                                                          3:30 PM - 5:00 PM

                                                          Session 26 - Scaling Patient Centricity with Digitalization
                                                          • Room: Grand Ballroom V
                                                          For close to a decade, pharma companies have been working persistently to implement the most ideal patient-centric framework. Their focus is primarily removing logistical barriers, reevaluating eligibility criteria and keeping patients engaged. While eConsent, crowdsourcing, direct-to-patient, education systems, virtual trials, wearables, etc., are gaining popularity and seen as means to... Read More

                                                          Session Chairs & Speakers

                                                          • Advanced Expert
                                                          • Panel Discussion
                                                          Session 27 - RBM Advancement in the Changing Clinical Research Paradigm – Where are we Headed to?
                                                          • Room: Grand Ballroom VII-X
                                                          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. The industry is evolving through improvement of key risk indicators (KRIs), expansion across therapeutic domains, use of technology and analytics and contextual application of the same... Read More

                                                          Session Chairs & Speakers

                                                          • Advanced
                                                          • Oral Presentation
                                                          Session 28 - Navigating the Dynamics and Challenges of “Clean” Interim Analyses – How to Hit a “Moving Target”
                                                          • Room: Grand Ballroom VI
                                                          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

                                                          • Advanced
                                                          • Panel Discussion

                                                          4:45 PM - 6:15 PM

                                                          Session 33 - Becoming a Certified Clinical Data Manager
                                                          • Room: Grand Ballroom I-IV
                                                          Thinking about Certification? Wondering when the new exam will be released and how best to study? This is the session for you. Join us as we reveal the specifications for the exam revision and details about the upcoming beta test of the new exam. We will cover three new exam... Read More

                                                          Session Chairs & Speakers

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

                                                            5:15 PM - 6:15 PM

                                                            Session 30 - Real World Data to Real World Evidence - A Holistic View from Data Management Perspective
                                                            • Room: Grand Ballroom V
                                                            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

                                                            • Expert
                                                            • Panel Discussion
                                                            Session 31 - Data Driven Innovation in Clinical Trials - Creating Value Chain Through Digital Transformation
                                                            • Room: Grand Ballroom VI
                                                            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

                                                            • Expert
                                                            • Panel Discussion
                                                            Session 32 - Pop-Up Session
                                                            • Room: Grand Ballroom VII-X

                                                              7:30 PM - 9:30 PM

                                                              25th Anniversary Networking Reception
                                                              • Room: Bar Vasquez
                                                              LIGHTS. CAMERA. ACTION. Welcome to the 25th SCDM Anniversary Networking Reception! Let’s go back to the past, to an epoch where everything was possible. Lively and happy streets, fancy and exclusive parties, jazz, economic prosperity, craziness, prohibitionist, rebellion and freedom. This year’s theme is designed to connect the past and the future –... Read More
                                                              • Networking

                                                              Wednesday, October 02

                                                              7:30 AM - 8:30 AM

                                                              Breakfast
                                                              • Room: Grand Ballroom Foyer
                                                              Sponsored by

                                                                7:30 AM - 12:00 PM

                                                                Registration
                                                                • Room: Harborside Ballroom Foyer

                                                                  8:30 AM - 10:00 AM

                                                                  Panel of Experts
                                                                  • Room: Grand Ballroom V-VI
                                                                  AGENDA: Panel of Experts  As an Anchor Plenary session to the overall Annual Conference, we are assembling a “Panel of Experts” representing the different towers within our industry to reflect on key challenges and opportunities relevant to our discipline. We aim to identify common as well as unique challenges we are facing... Read More

                                                                  Session Chairs & Speakers

                                                                  Mr.  Francois Torche
                                                                  CEO
                                                                  CluePoints
                                                                  Jennifer Duff
                                                                  Managing Director
                                                                  Accenture
                                                                  Jonathan Andrus
                                                                  M.S., CQA, CCDM, Chief Business Officer
                                                                  Clinical Ink, Inc.
                                                                  Mr.  Joshua Wilson
                                                                  Executive Director, Strategic Technology Advancement, Biometrics
                                                                  Syneos Health
                                                                  Lisbeth Bregnhøj
                                                                  MSc Pharmacy, PhD, Medicines Inspector, GCP and GVP
                                                                  Danish Medicines Agency
                                                                  Ni Aye Khin
                                                                  Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER
                                                                  FDA
                                                                  Patrick Nadolny
                                                                  Associate VP, Clinical Data Management and Programming
                                                                  Allergan
                                                                  • Plenary Session

                                                                  10:00 AM - 10:30 AM

                                                                  Coffee Break
                                                                  • Room: Harborside Ballroom, Foyer & Kent

                                                                    10:30 AM - 12:00 PM

                                                                    Session 34 - eSource Lessons Learned and Remaining Challenges Roundtable Discussion
                                                                    • Room: Grand Ballroom I-IV
                                                                    eSource has been discussed for over a decade and is now slowly becoming a reality. Several organizations are piloting and moving to production with eSource in four basic categories; wearables and devices, direct data capture, non-CRF data, and the secondary use of EHR data for clinical research. Yet many questions... Read More

                                                                    Session Chairs & Speakers

                                                                    • Advanced
                                                                    • Roundtable Discussion
                                                                    Session 35 - RBx - Going Beyond Risk Based Monitoring!
                                                                    • Room: Grand Ballroom VI
                                                                    Over the last 10 years the acronym RBM has meant a lot of different things to a lot of different people. Implementation of RBM has its challenges, but also its success stories. It’s time to break the mold on the term RBM and show what going Beyond Risk Based Monitoring... Read More

                                                                    Session Chairs & Speakers

                                                                    • Intermediate
                                                                    • Storytelling
                                                                    Session 36 - Digital Revolution in Healthcare and Its Impact on Clinical Data Management
                                                                    • Room: Grand Ballroom V
                                                                    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 Claims data - Patient... Read More

                                                                    Session Chairs & Speakers

                                                                    • Expert
                                                                    • Panel Discussion
                                                                    Session 37 - BYOD: Paving the Way for True Patient Centricity
                                                                    • Room: Grand Ballroom VII-X
                                                                    There is a paradigm shift on the horizon for how data is captured for clinical research. Patients are demanding a move away from the time-heavy model involving site visits, interviews, and manual data collection. It is time to move to virtual assessments powered by new eCOA and ePRO technologies. Implementing the... Read More

                                                                    Session Chairs & Speakers

                                                                    • Intermediate
                                                                    • Oral Presentation