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Programme

Overview

    • 08:15 - 08:50
      • Registration and refreshments

      • 08:50 - 09:00
        • Chairman's opening remarks

        • 09:00 - 09:30
        • Assessing the performance of sites and CROs to promote high quality data is consistently produced

          • Assessing performance continually by arranging regular meetings and defining project goals at the beginning of the trial

          • Considering which performance indicators should be implemented to ensure data quality and standardization

          • Generating a reporting system in order to make regular checks on performance to ensure any issues are quickly dealt with

          • Identifying potential high risk areas at the start of the trial to ensure due diligence is taken

        • 09:30 - 10:00
          • Speaker

            Jonathan Andrus – Chief Operating Officer, Chief Data Officer, CLINICAL INK

          Keeping the Patient and Site at the Center of Your Clinical Trial

          • Enable and encourage remote monitoring of clinical trial data through the use of eSource and other non-transcribed tools

          • Embrace the patient and site perspective when designing your clinical trials

          • Utilize tools and technologies that minimize redundancy and administrative burden

          • Engage and enhance the patient experience through the use of mobile apps and tools that keeps them connected throughout the study

        • 10:00 - 10:30
          • Speaker

            Philip C Ross, Ph.D. – Director, Clinical and Translational Data Science, BRISTOL-MYERS SQUIBB
          • Speaker

            Irene Pak – Associate Director, Disease Area Information Lead, BRISTOL-MYERS SQUIBB

          Clinical Visualization and Creation of a Data Lake - Another Step in the Evolution of Clinical Development?

          • Examine the challenges arising from the need to access, integrate and conform data throughout study execution

          • Discuss the advantages of data standardization and supporting earlier access to data

          • Demonstrate the use of the data to support clinical decisions during and after study conduct

          • Give examples of the impact a Data Lake in support of Clinical Program Decision Making

        • 10:30 - 11:00
          • Morning refreshments and networking

          • 11:00 - 11:30
            • Speaker

              Karyn Cassello – Director, Clinical Data Management, NEKTAR THERAPEUTICS

            Identifying the value of Risk Based Monitoring (RBM) and the role of the data manager in facilitating RBM

            • Examining why companies are moving towards RBM and how it helps to identify critical values and standardize data collection

            • Defining the role of the clinical data manager within RBM to ensure efficient implementation

            • Uncovering current FDA guidelines to assist in identifying risks in the study

            • Highlighting the need for smooth communication between data management and CRAs to facilitate the implementation RBM

          • 11:30 - 12:00
            • Speaker

              Patti Arsenault – Director, Global Head, Clinical Data Management, CYTEL

            In the Midst of This: A guide to preparing for and managing data for an Interim Analysis

            • In this presentation, we will discuss the following in regards to studies where an IA is planned

            • Database design: What are the special requirements for interim analysis and adaptive designs

            • Data cleaning for the interim look(s)

            • Effective communication with stakeholders: What data managers need to know and need to share

          • 12:00 - 12:45
            • Speaker

              Gina Eagle – Vice President of Clinical Development, INSMED
            • Speaker

              Robert J Boland – Associate Director of Innovation Strategy, Emerging Science & Innovation, JOHNSON & JOHNSON
            • Speaker

              Susan Walters – Senior Site Coordinator, SANOFI

            Ensuring the right balance between increasing the speed of data delivery and continuing to produce high quality data

            • Assessing the speed clinical data can be accessed via databases

            • Identifying the importance of proper procedures, staffing and reporting when collecting and reviewing clinical data

            • Anticipating potential issues at the start of the trial, such as missing data, and putting procedures in place that will allow data management to deal with the issue quickly

            • Evaluating the option of using automation systems on the clinical database to clean data which may speed up data delivery, without compromising quality

          • 12:45 - 13:15
            • Speaker

              Steve Young – Senior Vice President of US Operations, CLUEPOINTS S.A.

            How Risk-Based Monitoring can foster better collaboration between data management and site monitoring

            • Understand the traditional silos in Clinical R&D organizations and the difficulties arising from them

            • Understand how effective RBM is enabled

            • Learn how to drive greater cross-functional collaboration and understanding through RBM

          • 13:15 - 14:45
            • Lunch and networking

            • 14:45 - 15:15
              • Speaker

                Thomas Verish – Senior Director, Data Operations & Clinical Infrastructure, CSL BEHRING

              Identifying the requirements for clinical data review to ensure due preparation for benefit of trial timeline

              • Examining the importance of clinical data reviews in identifying and investigating adverse events

              • Identifying the relevant data required for patient profiles reviews, such as inclusion/exclusion of certain criteria

              • Addressing the challenges data management face with clinical reviews, such as missing data or data entry errors, to ensure patient safety

              • Identifying the advantages of utilizing CDISC SDTM model for clinical data collection and review

            • 15:15 - 15:45
            • The Future is Connected Data

              • Learn how and why a failure to have an overarching data strategy can cause you to lose competitive advantage

              • Hear real life examples of the state of data in a trial by trial approach and how complex trials and mergers can create chaos even in the most strategic companies

              • Identify clear advantages that come when you leverage cloud based solutions and advanced technologies to transform data across trials into useful information for real-time insights and decision making

            • 15:45 - 16:15
              • Afternoon refreshments and networking

              • 16:15 - 16:45
                • Speaker

                  Wandy Romain – Specialist, Clinical Data Management, MERCK ANIMAL HEALTH

                Recognizing technological advancements that improve data collection allowing study timelines to be met sooner

                • Evaluating data capture systems that do real time data checks to improve data quality

                • Evaluating models of data collection to ensure real time data access

                • Identifying challenges with data collection models that pose technological risks with data safety

                • Advantages of using the CDISC standard model for data collection and submission, SDTM

              • 16:45 - 17:15
                • Presentation Reserved for Tamr Inc

                • 17:15 - 17:45
                  • Speaker

                    Wenle Zhao – Associate Director of IS/IT, Data Coordination Unit, MEDICAL UNIVERSITY OF SOUTH CAROLINA
                  • Speaker

                    Catherine Dillon – Associate Director of Trial Operations, MEDICAL UNIVERSITY OF SOUTH CAROLINA

                  Enhancing clinical trial quality and efficiency by integrating trial operation information and case report form data

                  • Integration of regulatory document collection management, subject enrollment, real-time central randomization, and study drug distribution coordination enhances regulatory compliance and reduces subject eligibility violation and treatment assignment mistakes

                  • Integration of adverse event reporting, medical safety monitoring, and central outcome adjudication management promotes efficient coordination and effective human subject protection

                  • Integration of rule-based real-time case report form data validation, central interactive data monitoring, and risk-based on-site data monitoring improves trial operation, data quality, and clinical trial results

                • 18:15 - 18:25
                  • Chairman’s summation and close of conference

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