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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

              Susan Walters – Senior Site Coordinator, SANOFI
            • Speaker

              Robert J Boland – Associate Director, Emerging Science & Innovation, JOHNSON & JOHNSON CONSUMER R&D
            • Speaker

              Gina Eagle – Vice President of Clinical Development, INSMED

            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
                • Speaker

                  Ted Snyder – Senior Solution Architect, TAMR

                Applying Machine Learning to Achieve Clinical Data Integration at Scale

                This talk will explain how companies are applying a unique workflow that combines machine learning and expert human review to dramatically reduce the time to integrate new studies for data visualization and analytics. Several real world use cases will be presented including: • Improving reporting and analytics for biomarker trial operations

                • Enabling translational research by merging biomarker and clinical data

                • Unifying legacy trial data for exploratory analysis

              • 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

              • 17:45 - 18:15
                • Chairman’s summation and close of conference

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