ECDM2015+Header

Programme

Overview

    • 08:30 - 08:45
      • Registration and refreshments

      • 08:50 - 09:00
        • Opening remarks

        • 09:00 - 09:45
          • Speaker

            Susan Mullin – Associate Director, Business Operations - BRISTOL-MYERS SQUIBB
          • Speaker

            Oksana Gecha – Associate Director, Data Management - BRISTOL-MYERS SQUIBB

          Unravelling current best practice ideas and risk monitoring strategies in today’s climate to sharpen your RBM strategy in accordance with the current trends

          • Prioritizing resources around identifiable regulatory and operational risks to safeguard your quality and integrity of data

          • Discussing best practice RBM techniques to minimize the time spent on “frequent on-site monitoring and 100% data”

          • Reviewing all available technology on a frequent basis to find the most appropriate type to your risk based monitoring strategy and be aware of any new inductions to the market

          • Leveraging technology both as a communication tool with investigative sites and as a tool to manage risks throughout the trial

          • Completing a study risk assessment to develop a monitoring plan that best suits your study

        • 09:45 - 10:15
        • Managing high quality clinical trial data from cradle to grave: the need for metadata management

          • Defining and governing clinical meta data standards

          • Developing automated and custom inline data quality checks using OpenCDISC as a rule engine

          • Frequent transmission of high quality data to the Sponsor for immediate analysis and visualization

          • Building Clinical Trial Data Stores – with data and metadata

          • Near real time clinical trial data visualization on a regular basis during trial conduct

        • 10:15 - 10:45
          • Speaker

            Susmita Gupta – Global Project Lead Data Management - CSL BEHRING

          Achieving harmonious relationships with strategic partners to deliver quantifiable improvements whilst maintaining regulatory guidelines in risk based monitoring.

          • Working in unison to achieve regulatory harmony through improved dialogue, a common goal and improved process

          • Establishing roles within a strategic partnership to achieve study objectives without the need for follow up work

          • Guidance on workload balance between parties to meet expectations through examination of real life scenarios

          • Maintaining a cross functional view to ensure timely delivery

          • Building a multi partner model that continues to deliver goals and objectives without consuming budgets

        • 10:45 - 11:15
          • Morning refreshments and networking

          • 11:15 - 11:45
            • Speaker

              Rishi Gulati – Head, Innovation Centre of Excellence - CELGENE

            Evaluating new CDM systems to minimize fragmentation, improve tools and ensure informed decisions are made in the wake of discontinued and outdated services.

            • Developing a road map to success to identify needs based on business size

            • Comparing the spectrum of technologies to determine those that support your business yet drive forward cost effectiveness

            • Forecasting future needs to ensure system maintains technical relevance

            • Evaluating cross functional strategies with a top down view to ensure smooth transition and system integration

            • Evaluating CDM in today’s context to predict future changes that are process technology and cross functionally driven

          • 11:45 - 12:15
            • Speaker

              Terry Katz – Director, Head of Global DM and Statistics - MERCK

            Focusing on implementation of adaptive design trials to aid compliance with regulatory requirements

            • Reviewing the impact adaptive trials have on clinical data management to ensure that no single factor is overlooked during the course of study

            • Defining the pre-requisite of protocols to identify and evaluate the adaptations necessary to execute a study

            • Monitoring progression of adaptations through the use of interim analysis needed in order to execute a study

            • Modifying the data management plan in order to support such adaptations made

            • Communicating effectively with all those involved in the adaptive design process to ensure everyone is in tandem

            • Enhancing adaptive design trials: tips and techniques for future recommendations

          • 12:15 - 12:45
            • Session sponsored by Cytel

            • 12:45 - 14:00
              • Lunch and Networking

              • 14:00 - 14:45
              • Panel Discussion - Reviewing what the future has in store for clinical data management: lessons learnt and how we can move forward

                • Clinical Data Flow: The end-to-end process that takes clinical data from point of origin to final disposition, inclusive of all nodes through which data travels

                • Clinical data flow is a team sport in which clinical data management can take the lead: integrated process

                • Addressing the adoption of CDISC standards

                • Addressing the implications of the FDA’s critical path initiative in pushing Risk Based Monitoring and SDTM adoption to enable electronic regulatory submissions for sponsors of human drug clinical trials

              • 14:45 - 15:15
                • Speaker

                  Robert Boland – Directing Senior Manager, External Innovation R&D IT - JOHNSON & JOHNSON

                Combating increased global data streams to enable quicker access and greater control through the use of cloud storage, a Case Study on JACE (Janssen Collaborative Environment)

                • Realising the advantages of a cloud based system throughout the entire clinical trial environment to drive quantifiable results

                • Controlling multiple data streams to achieve system integration

                • Establishing improved communication and real time data visibility with partners to improve work stream efficiencies

                • Exploring advances in cloud based technology to achieve safe data storage in an age of digital pirates

                • Harnessing greater oversight of data through cloud based controls and audits

              • 15:15 - 15:45
                • Speaker

                  William Crerand – Senior Director, Data Management - DAIICHI SANKYO

                Building a preferred service model to avoid clinical bias of a full service model and ensure data quality and control are maintained.

                • Understanding partner strengths to build an efficient model that enables clinical and data qualities to be achieved

                • Maximising strengths to achieve data value and potential through targeted focus of individual partners

                • Developing harmony across multiple partners with focused goals to achieve an efficient division of labour

                • Maintaining data standards across all silos to eradicate data redundancies and concentrate efficient workflow streams

                • Taking advantage of advanced skill sets to improve workflow efficiencies by building specialised tolls within targeted areas

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

                • 16:15 - 16:45
                  • Speaker

                    Wayne Crumpton – Associate Director, Clinical Data Management - SHIRE

                  Incorporating strategies employed by CROs and sponsors to optimize the process of outsourcing

                  • Outlining tried and tested current outsourcing approaches to determine what would be suitable for you

                  • Analyzing benefits associated with in-house, outsourcing and off-shoring procedures to maximize return within your trial

                  • Selecting the most appropriate technology vendor, platform or application to address the unique requirements of the clinical trial investigator and patients

                  • Defining how to select the right approach based on the study type, cost, time and quality of the results

                  • Analyzing challenges associated with the subcontracting work with vendors to explain how to address and overcome this in future studies

                  • Implementing the required amount of oversight and expertise to drive CRO data management or database design deliverables

                • 16:45 - 17:15
                  • Speaker

                    Ying Yan – Executive Director Statistics and Data Management - HELSINN THERAPEUTICS

                  Defining the relationship and role of the data manager and data scientist to improve collaboration and effectiveness within clinical studies.

                  • Defining roles and responsibilities in a constantly evolving technologically advanced clinical study environment to manage workflow streams

                  • Appreciating strength and skills to better manage expectations throughout a trial duration

                  • Realising effective communication and interface to generate a strong collaboration between data mangers and data scientists

                  • Ensuring an enablement environment between the two parties to extract full data value from a study

                  • Facilitating data manager and data scientist collaboration to allow specification setting for validation and editing checks prior to data collection

                • 17:15 - 17:45
                  • Speaker

                    James Manning – Head, External Data Operations - BRISTOL-MYERS SQUIBB

                  Exploring new data management paradigms to work effectively across data domains to improve study quality in an accelerated program environment

                  • Facilitating change in a streamlined environment by identifying essential skill gaps

                  • Defining responsibilities in a hybrid role to continually develop strategies to achieve accelerated program timeframes

                  • Bridging the gap to ensure skills are readily available through accelerated knowledge sharing programs

                  • Examining how hiring practices have changed and what is needed to anticipate the needs of future clinical studies

                  • Rooting a strong strategic and project management focus to achieve timescales across multiple partners through a top down leadership approach

                  • Managing clinical data streams efficiently in an accelerated program environment with the use of advanced roadmaps and methodology

                • 17:45 - 18:00
                  • Close of day one

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