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Programme

Overview

    • 08:00 - 08:15
      • Registration and refreshments

      • 08:15 - 08:30
        • Speaker

          William Crerand – Senior Director, Data Management - DAIICHI SANKYO

        Opening remarks

      • 08:30 - 09:00
        • 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

      • 09:00 - 09:30
      • 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

      • 09:30 - 10:00
        • Speaker

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

        A Good Data Manager from Statistician's Point of View

        • 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

      • 10:00 - 10:30
        • Speaker

          Rukhsana S – Sr. Clinical Data Analyst, NAVITAS
        • Speaker

          Malini K – Sr. Clinical Data Analyst, NAVITAS

        Using data standards to improve efficiency in the set-up of clinical trials

        • Significance and efficiencies of CDASH in terms of traceability and consistency of data collection and analysis across studies

        • CDASH integration into the clinical data management system for extensive library capabilities and collaboration functionalities

        • Usage of CDASH Standards in softwares named DSG Designer & eCaselink (Data designing, collection and data management Instruments from DSG Inc group) evidencing the benefits of CDASH globalisation

        • Functionalities of DSG instruments from study design phase to closure phase depicting the reusability of CRFs

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

        • 11:00 - 11:30
          • Speaker

            Alex Loboda – Validation and QC Manager, EISAI

          How to ensure data submissions pass DataFit standards through practical case study lessons from Eisai

          FDA has recently introduced JumpStart, a service that is modernizing the drug review process by implementing standard review and analysis tools based on the CDISC standards. On December 17th, FDA has also announced that future submissions will be required in CDISC format. This means that every sponsor must now implement a robust process that results in CDISC compliant submission data that meets FDA requirements

          • Revealing Eisai’s project to develop CDISC preparation process to support two upcoming submission ensuring Eisai meet new requirements by in-sourcing SDTM conversion and regulatory data preparation process

          • Sharing Eisai’s experience of implementing an internal process for development of high quality submission datasets, Define file and Study Data Reviewer’s Guide

          &bulll; Present metrics on how the process resulted in efficiencies between first and second submissions

        • 11:30 - 12:00
        • Re-inventing Clinical Trials: Conceiving and Implementing Innovations in CDM

          • Developing software tools that automate routines for quicker “go live”

          • Insights into creating and managing more of a “team approach” model to maximize productivity from distributed personnel

          • Improving workflow processes to reduce costs and achieve tighter control

        • 12:00 - 12:30
        • 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

        • 12:30 - 13:30
          • Lunch and Networking

          • 13:30 - 14:00
            • 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

          • 14:00 - 14:30
            • Speaker

              Rajneesh Patil – Director, Integrated Process and Technology, QUINTILES

            Case Study: Delivering Results with Risk-based Monitoring approaches

            The market is adopting RBM to transform clinical development. Technology is powering this with new roles and processes, enabling faster, more informed decisions. In this session you’l hear about;

            l • The role technology plays in integrating patient, site, study and program data

            • How new processes with new roles is delivering faster ‘analysis ready’ data

            • See how holistic data is improving data quality and is impacting safety

            • Understand how holistic data and predictive analytics can enhance patient safety

          • 14:30 - 15:00
            • 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

          • 15:00 - 15:30
            • Afternoon refreshments and networking

            • 15:30 - 16:00
            • Risk Based Monitoring – Making an Impact on Study Quality

              • Identifying and evaluating potential study risks that may impact the overall study quality

              • Determining key study aspects to ensure data is collected appropriately

              • Leveraging a cross-functional approach to address reporting needs

              • Monitoring data quality to ensure early detection of potential problems and proactive corrections

            • 16:00 - 16:30
              • Speaker

                Daru Sharp – Associate Director, 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

            • 16:30 - 16:45
              • Close of day one

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