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Programme

Overview

    • 08:00 - 08:40
      • Registration and Refreshments

      • 08:40 - 08:50
        • Chairman's opening remarks

        • 08:50 - 09:20
          • Speaker

            Jean Barclay – Project Manager, Global Clinical Development and Regulatory Affairs, LUYE PHARMA GROUP

          Defining strategic models for data collection to ensure real time data access in databases

          • Utilising data capture systems with real time data checks to increase data quality and avoid ad hoc data entry responsibilities

          • Creating upfront data checks to add data value

          • Assessing technological advancements to aid data collection processes and reduce time consumption

          • Analysing technological risks associated with data safety to avoid security breach of collected and stored data sets

        • 09:20 - 09:50
          • Speaker

            Dave Alderson – Vice President of Business Development, EDETEK, INC.

          The Enterprise approach – taking clinical research and data standardization to the next level to enable future clinical development

          • Identifying the benefits from implementing standards for clinical information to manage your data and business in a risk-free environment

          • Outlining relevance of efforts of data formatting for more accurate and rapid assessment of compound and device safety and efficacy to facilitate regulatory approval quickly

          • Providing valuable input into sound product development strategies by evolving data formatting into assets

          • Applying conformance efforts to other types of data such as trial design, trial management, reporting modules, business rules, milestones and workflows to increase interactions across different functions to meet business growth needs and strategic financial objectives

          • Investigating comprehensive standardization approach to create a structure for future clinical development to increase productivity by more accurate decision-making

        • 09:50 - 10:20
          • Speaker

            Daru Sharp – Early Clinical Science and Operations Lead, BRISTOL-MYERS SQUIBB

          Implementing better planning solutions to optimize data consumption

          • Biostatistics vs data science

          • Fit for purpose data reporting

          • Better planning to optimize data consumption

        • 10:20 - 11:00
          • Morning refreshments and networking

          • 11:00 - 11:30
          • Identifying easy to implement approaches for data visualization to ensure quick access to visual data set charts and maximise data potential

            • Examining the potential data quality gaps in a traditional data review approach

            • Examining how utilizing data visualization tools can help to focus resources where issues lie

            •Demonstrating how some common data review issues can be addressed more effectively utilizing visualization tools

          • 11:30 - 12:00
            • Speaker

              Georgina Wood – Practise Head Clinical Data Services, NAVITAS INC

            Clinical Data Integration – Integral to Risk Based Monitoring, Quality based payments and SDTM like outputs

            •Establishing next generation clinical analytics by incorporating a robust clinical data integration platform as an essential and pre-requisite foundational architectural component

            • Realizing differences in scope and complexity of integration across enterprises by adopting SaaS based data collection and clinical trials management systems

            • Analyzing a custom development of a data warehouse with scope of integrating data from output for operational and bio-statistical programing needs

            • Discussing a SaaS based integration platform with the scope of integration across all systems enabling adaptive monitoring (RBM with Central and Medical Monitoring)

          • 12:00 - 12:30
          • Maximizing efficiency of clinical data review by using visualization tools and techniques

            • Defining scope and gathering requirements for data review goals in the organization

            • Investigating benefits of graphical data representation compared to review of traditional tables

            • Analyzing different types and categories of clinical data review with correlated examples of graphical representations e.g. scatter and box plots for detecting outliers; line charts and shift plots for determining trends etc.

          • 12:30 - 14:00
            • Lunch and networking

            • 14:00 - 14:30
              • Speaker

                Tracey Newman – Associate Director, Data Management, OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC

              Achieving data integration across different data sources to shorten the clinical trial cycle and reduce costs

              • Reviewing all available technology on a frequent basis to find the most appropriate e-source system integration model

              • Analysing the best practice of online systems to allow for effective data reconciliation

              • Evaluating strategic models of data reconciliation based on data flow type, vendor services and systems being in use to best match you with the right type of data solution

              • Implementing e-source systems to comply to standards across all silos to eradicate data redundancies

              • Establishing strategies to avoid security concerns regarding data repositories, cloud based solutions/warehouses

            • 14:30 - 15:00
              • Speaker

                Patti Arsenault – Director, Global Head, Clinical Data Management, CYTEL

              Data Management and Biostatistics – two teams that need to be closely aligned

              • Exploring the power of cooperation between Data management and Biostatistics

              • Needing input; protocol to CRF; how complete is complete?

              • Analyzing the pros and cons of integrating your electronic data into EDC

              • Exploring the importance of EDC systems from both, CDM and Biostatics point of view

            • 15:00 - 15:45
              • Speaker

                Charles Johnson – Associate Director, Data Management Biostatistics and Data Operations, DAIICHI SANKYO
              • Speaker

                Lakshmi Mallela – Principal Global Data Manager, JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON&JOHNSON
              • Speaker

                Elsie Mathews – Director, Global Data Operations, BRISTOL-MYERS SQUIBB

              Panel discussion: Assessing the impact of technological development on day to day data management

              • Unravelling current trends in data management till use of technological advancements are considered

              • Creating successful strategies to apply technological developments

              • Addressing risks to reduce costs and ensure consistent performance

              • Ensuring product training to optimize utilization of technology and maximize potential

              • Investigating performance level to ensure quality throughout your trial

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

              • 16:15 - 16:45
              • Implementing processes for high data standards

                • Implementing a cost-benefit technology for clinical research services

                • Adopting traditional solutions in a more efficient way for faster data entry and access solutions

                • Evaluating security issues associated with integrating new electronic systems

                • Evaluating real time examples of systems application in clinical research

              • 16:45 - 17:15
                • Speaker

                  Jonathan Andrus – Chief Data Officer, CLINICAL INK
                • Speaker

                  Charles Bunn – Senior Director, Data Management, OTSUKA PHARMACEUTICALS

                eSource and You – Perfect Together!

                • Rating the flavors

                •• Are the rules the same here? Breaking down the barriers to eSource

                • Adopting the wrong RBM value proposition?

                • Case Study: Results from over 3 years of eSource studies at Otsuka

              • 17:15 - 17:45
                • Speaker

                  Indra Agarwal – Senior Manager, Data Management, OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC.

                Measuring the performance of sites and CROs to ensure data quality and consistent performance are maintained

                • Driving the successful achievement of project goals by measuring performance and productivity of sites and CROs to ensure timeliness and data quality

                • Defining performance indicators to test standardization throughout every part of the trial

                • Adopting a performance reporting system to ensure regular performance checks in order to maintain high standards

                • Considering mistakes previously made at the start of your trial to minimise risks

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