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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
          • Past Speaker

            Terry Katz – Director, Head of Global Data Management and Statistics, MERCK ANIMAL HEALTH

          Examining eSource system integration models to improve efficiency and shorten trial timelines

          • Identifying available technology to find the most appropriate eSource system integration model to provide real time data

          • Assessing challenges to data management using eSource and considering how to achieve the full potential of eSource in clinical trials

          • Implementing eSource to alter the process of data collection whilst still complying with FDA standards

          • Examining ways to avoid security concerns regarding data depositories and data warehousing

        • 09:30 - 10:00
        • Continuous monitoring of clinical and operational events – a comprehensive approach for improving study quality, data integration and analytics

          • Benefits and use cases of events monitoring for patient safety, site performance and study quality

          • Event-driven human and systems workflows in clinical operations

          • Real time cross system data integration

          • Technological platform for gathering and processing of clinical events

        • 10:00 - 10:30
          • Speaker

            Audrey Hill – Director, Data Management, ADVAXIS

          The Evolving Role of Clinical Data Management

          • Impact of revised GCP and regulatory changes on clinical trial conduct and planning

          • Maximizing the use of new technology in clinical data management development

          • Tools and technologies for clinical data management and development planning

          • Building effective collaboration across cross-functional teams and organizations

          • Training for increasingly complex functional, regulatory & organizational environments

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

          • 11:00 - 11:30
            • Past Speaker

              Laszlo Vasko – Senior Director, Information Integration Lead, R&D Information, ASTRAZENECA

            Capturing clinical trial design decisions

            • Discuss challenges retaining clinical project memory

            • Case studies on efforts to capture project memory and design rationale

            • Overview of a Phuse initiative to create a cross industry information model / approach for clinical development program design

            • Current systems and clinical data standards are designed to capture the outcome of clinical trial design activities, but not the rationale, scenarios considered, and decision making history. There’s opportunity to structure and retain decisions, rationales, supporting information in order to ensure project memory is retained. A cross industry information model can further facilitate communication and collaboration between sponsors as well as with agencies

          • 11:30 - 12:00
          • Harnessing the power of data visualization and statistics to enhance the collaboration between clinical operations, data management and biostatistics. CSM+RBM Simplified

            • Initial findings of the pilot implementation of risk based monitoring (RBM) incorporating centralized statistical monitoring (CSM) by a partnership of a CRO, a data analytics vendor, and a pharma sponsor

            • The role of CSM in detecting anomalies, outliers and patterns as part of RBM will be described

            • Strategies for ensuring a consistent across department implementation will be outlined

            • Demonstration of how key risk indicators (KRI) can be presented using different approaches based on the end users role

            • Implementation of a model that can scale with a project’s scope and complexity

          • 12:00 - 12:45
            • Past Speaker

              Audrey Hill – Director, Data Management, ADVAXIS
            • Past Speaker

              Patrick Zbyszewski – Executive Director of Project and Data Management, ONCONOVA THERAPEUTICS

            Examining the technological side of Risk Based Monitoring and how it can promote more efficient data standardization and speed up clinical trial timelines

            • Assessing RBM technology available and how it can identify critical values in the study to minimize the number of sites monitored and reduce costs

            • Examining how to maximize the use of RBM technology for data verification and data quality by identifying the risks in the study

            • Defining the regulatory agencies guidelines on RBM technology to ensure compliance with FDA regulations, as RBM is non-standards

          • 12:45 - 13:45
            • Lunch and networking

            • 13:45 - 14:15
              • Speaker

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

                Kenneth David Fernandez Prada – Senior R&D Engineer,DEPUY-SYNTHES JOINT RECONSTRUCTION (JOHNSON & JOHNSON)

              Identifying advantages of wearable technologies and how they can be used in trials whilst complying with industry standards

              • Learning about various wearable technologies available and how they can be incorporated into clinical trials

              • Defining the role of data management in development, validation and deployment of wearables

              • Identifying challenges with moving over to wearables and how to ensure patient and data safety is paramount

              • Understanding requirements and mHealth standards in relation to wearables

            • 14:15 - 14:45
            • Converting the data liability into an asset

              • Data sources have proliferated, but systems to make sense of this data deluge haven't kept pace. As a result, it is becoming increasingly difficult to manage complex, global clinical trials that are increasingly outsourced

              • We'll spend this time discussing a case study for how a customer of Comprehend's combined internal personnel-oriented change management with an investment in Clinical Intelligence to integrate data and operations teams and change the culture to be more data-driven

              • Join this session to learn implications of this approach for this particular sponsor, and a few details regarding the small steps you can take as a company to accomplish a similar goal

            • 14:45 - 15:15
              • Afternoon refreshments and networking

              • 15:15 - 16:45
                • Speaker Hosted Roundtables

                  Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables

                  • Are changes to the data review process needed to support risk-based monitoring process? Carol Antinori – Speaker

                  • Discussing various esource system integration models Terry Katz – Speaker

                  • Examining the different approaches to data visualization (challenges with data visualization tools) Catherine Dillon – Speaker

                  • Identifying how best to manage relationships with CROs (communication between DM and CRO) Kevin Douglass – Speaker

                • 16:45 - 17:00
                  • Chairman’s summation and close of conference

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