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Programme

Overview

    • 08:30 - 08:50
      • Registration and refreshments

      • 08:50 - 09:00
        • Chair’s opening remarks

        • 09:00 - 09:30
          • Speaker

            Peggy Siemon-Hryczyk – Group Director, Clinical Operations, Biometrics and Data Management - EISAI

          Adopting a risk based profile approach to clinical data monitoring while focusing on preventing likely sources of error to mitigate risk and protect trial integrity

          • Complying with FDA standards to shift monitoring processes from excessive concentration on source data verification to comprehensive risk-driven monitoring while steering away from the traditionally automatic industry approach

          • Performing a risk assessment to identify early warning signals and appreciate the risks that could affect the collection of critical data or the performance of critical processes

          • Defining the level of risk through source data verification depending on the contract to maximize on-site monitoring findings

          • Tailoring a monitoring plan to your specific trial while considering the data integrity risks of the trial to identify the various methods intended to be used and the rationale for their use

          • Comparing and contrasting a reduced versus risk based profile in order to determine the benefits and drawbacks of both profiles and mitigate risk

          • Increasing the quality of clinical trial data while focusing on the study performance and data reports to encourage the safety of those taking part in the clinical trial

        • 09:30 - 10:00
          • Speaker

            David Stein – Senior Director of Product Management - PAREXEL INFORMATICS

          Keynote Presentation: Highlighting trends in clinical data integration and analysis - platforms, warehouses and the cloud

          • Explore the problems we are seeking to solve by implementing cloud-based solutions, including clinical data warehouses and integrated eClinical platforms

          • Consider case studies showing how biopharma companies are combining disparate data sources for data mining and visualization

          • Understand how technologies and standards are delivering new insights and efficiencies previously hidden in large data sets

          • Determine why early clinical data warehouse projects failed and how new models are successful

          • Review models for accessing and integrating data in the cloud and on-premise

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

          • 10:30 - 11:00
            • Speaker

              Thoma Kikis – Founder, Chief Visionary Officer - KANNALIFE

            Session reserved for KannaLife

          • 11:00 - 11:30
            • Speaker

              Mike Weitz – Marketing Director - CYTEL INC

            Session reserved for CYTEL INC.

          • 11:30 - 12:00
            • Speaker

              Terry Katz – Director, Global DM & Statistics - MERCK

            Adjusting data management processes through adaptive trials by making changes in response to captured data for a specific therapeutic area

            • Reviewing preliminary data that has been captured while a trial is running to develop appreciation of different responses to therapeutic drugs

            • Making changes to the trial design in response to preliminary data that has been analyzed in order to improve trial integrity and validity

            • Considering how best to adapt aspects of the trial if the trial site is located elsewhere through making decisions early on and adopting more of an aggressive focus

            • Establishing how to keep a trial fully blinded if doses are changed while maintaining trust with trial subjects and utilizing electronic data capture

            • Appreciating how to deal with interim changes that go along with the adaptive design trial through implementing adaptive clinical trial guidelines from the regulators

            • Managing the logistical and operational management components of adaptive clinical trials considering the increased need on the sponsor side to incorporate this

          • 12:00 - 13:30
            • Lunch and networking

            • 13:30 - 14:00
              • Speaker

                Wim Verreth – Head Project Management Biometrics & Project Director Biometrics and Medical Affairs - SGS LIFE SCIENCE SERVICES

              Introducing Clinic Automation in a Phase I unit with end-to-end eSource data processing

              • Understanding clinic automation and eSource concepts, while referring to associated regulations (FDA, EMA and CDISC)

              • Discussing the benefits of clinical automation and working with an eSource system

              • Managing the challenges of implementing an eSource system

              • Delving into eSource and centralized monitoring

              • Appreciating how to process eSource data within Data Management

              • Sharing implementation experiences while replacing paper source at our Clinical Phase 1 Unit through embedding eSource in all operational processes

            • 14:00 - 14:30
            • Establishing current CDISC guidelines while considering the implications if/when a submission is rejected

              • Realizing the added value of a global data standard to fully appreciate all systems and processes

              • Recognizing updates to CRF submission and considering strict timelines for submission in order to adhere to industry guidelines

              • Standardizing your data collection process and enforcing data mapping through incorporating new therapeutic areas to identify how expectations have changed

              • Streamlining CDISC global standards by clinical data pooling through standard reporting and data transfers with partners

              • Converting clinical data into warehouse ready CDISC standard structure in order to facilitate the usability and value of this data and answer specific safety requests

            • 14:30 - 15:00
            • Improving data standards and establishing secure medical coding and safety data through CDASH guideline compliancy

              • Determining which common data elements should be captured on all CRFs through CDASH data collection

              • Creating a CDASH Serious Adverse Event domain to compliment the Adverse Event to reduce duplication of data collection and to provide standardized metadata

              • Justifying why a specific variable should be gathered while determining its relationship to the submission SDTM dataset

              • Establishing standardized CDASH libraries in order to allow companies to have a standardised code and mappings to manipulate operational CDASH data into SDTM datasets

              • Investigating how CDASH, SDTM and ADaM provide an end-to-end solution for the industry from the point of capture to submission to appreciate the need for these standards

            • 15:00 - 15:15
              • Speaker

                Mark Williams – Vice President Data Services - ACI CLINICAL

              Spotlight Session - ACI Clinical

              With the now widespread commercial and regulatory adoption of clinical data standards as proposed by the CDISC organization, Industry and regulatory agencies are now moving beyond the challenges of the “data standards adoption phase’ into the “data standards ROI phase” of clinical data collection, management, analysis and integration. This talk will provide a short review of recent history and some real examples of using CDISC standards to drive rapid safety and efficacy analysis.

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

              • 15:45 - 16:30
                • Speaker

                  Ron Bourque – Senior Manager eClinical TMS - MEDIMMUNE
                • Speaker

                  Pat Catanzariti – Global Director, Data Management - BRISTOL-MYERS SQUIBB

                Panel Discussion: Exploring vendor management strategies adopted by different companies to ensure your data submissions are processed in an efficient manner

                • Evaluating current updates with regards to new standards regarding submission when partnering with vendors to ensure your practices are aligned

                • Accenting new formatting standards and addressing issues through improving processing methods and evading poor quality of data

                • Determining how much oversight other companies are enforcing to achieve a balance of what you can in-house and what you can outsource in a targeted manner

                • Assessing how vendors clean by subject to decrease waiting times for the cleaning process

                • Ensuring local vendors are also aware of CDISC standards through aligning your processes and streamlining any issues that may arise

                • Improving the level of ownership from a sponsor perspective in order to improve communication

              • 16:30 - 17:00
                • Speaker

                  Colleen Cox – Senior Manager, Data Management - INFINITY PHARMACEUTICALS

                Clinical data management is more than just the management of the data from the study trial

                • Distinguishing between a knowledge base and expertise - how do you train (and to what level) for each software

                • Harnessing the skill set needed (either to be developed or supported) for vendor selection, RFP development, continuous improvement, governance as well as oversight of day to day tasks

                • Determining how to keep CDMs up to date with changes in technology that drive changes in processes and procedures?

                • Establishing the DM PM role as well as the DM Program Manager as key components not only in the successful execution of a trial, but also in the creation and submission of regulatory documents

                • Discussing how to recruit and hire for such a wide range of job requirements and expectations

                • Determining the best way to retain the employees that do you find

              • 17:00 - 17:30
              • Improving communication with the CI team and recovering study store up and close processes to fully appreciate the changing landscape of the Data Manager role

                • Appreciating the move from technical responsibilities to more project manager role in order to determine the best way to deal with this transformation process

                • Revealing the major changes in responsibilities for a data managers while evaluating new skills that may developed

                • Outlining new roles within data management – integration and information managers in order to determine how this affects the overall data manager role

                • Implementing the best strategy to oversee all the activities in regards to data management in efforts to estimate the level of responsibilities data managers will hold in the future

                • Exploring the best way people can be trained to be knowledge workers rather than process executors in order to move forward with a study more efficiently

                • Discussing a specific example of the adapted data manager role within a company in order to illustrate the future responsibilities

              • 17:30 - 17:45
                • Chair’s summation and close of day one

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