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EUClinicaldata+header

Programme

Overview

E-Clinical Trials

E-Clinical Trials

    • 08:15 - 08:45
      • Registration and refreshments

        Conference

      • 08:50 - 09:00
        • Chairman's opening remarks

          Conference

        • 09:00 - 09:30
        • A Merck Case Study: EDC to CDR (SDTM) Data Flow Enabled in the Cloud

          Conference

          • Overcoming the challenges in harmonizing patient data in large-scale and many simultaneous clinical trials

          • Utilizing cloud-based integration and SDTM data transformation using cloud-based services

          • Challenges and benefits of adopting cloud services for life sciences

          • Through a case study, how Merck used cloud-based services to transform clinical trial data processes

        • 09:30 - 10:00
        • Designing your eCRF in the most effective method by weighing up all the influencing variables in order to address and balance required demands

          • Outlining the challenges involving technology, protocol-driven science, standardisation, validation and work-flow to create usability for both PDC and EDC studies

          • Acknowledging the competing/ complementary demands made on the CRF or eCRF by site users, sponsors and/or CROS to address balancing of standards

          • Considering the preference of team members and site users by engaging in collaboration and negotiation of the human issues involved

          • Emphasising the importance that study designers have in achieving and driving core clinical database building in addition to the technology

          • Using technology initiatives to cope with the growing importance of postmarketing data collection, economics of drug therapy and patient reported outcome data

          • Finalising the study report to be a product of sophisticated computer programmes and statistical analysis and realising that data will only be as good as your CRF/eCRF allows; finalising the study report to be a product of sophisticated computer programmers and statistical analysis

        • 10:00 - 10:30
          • Speed networking

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

              Conference

            • 11:00 - 11:30
            • Reviewing the benefits of focused electronic solutions to alleviate the significant pressure associated with the trial and marketing of your drug

              Conference

              • Outlining the current technology- driven strategies in place to maximise the potential revenue gained from a drug by maximising its period without competition

              • Using technology initiatives to cope with the challenges of increasing regulatory requirements coupled with reforms in health care services

              • Identifying the need for sponsor companies to invest significantly in technological solutions to maximise efficiency during this constant flux of requirements and demands

              • Adding emphasis on business process re-engineering and continual technology improvements to engender long-term clinical efficiencies and cost benefits

              • Deciphering the impact of delay, deficiency and lack of quality to highlight, furthermore the importance of a technology-driven environment

              • Striking the correct balance between time, cost, process and quality to outline important demands on the sponsor company

              • Applying e-clinical technology, including EDC in such a context to offer superior benefits to sponsors in an environment geared towards wider technology adoption

            • 11:30 - 12:00
              • Speaker

                Yaniv Naor – Master Data Management Europe, ratiopharm

              Performance Management: Master Data Management Europe

              Conference

              • Considering Master Data Management in Ratiopharm

              • Addressing the two variations of handling Master Data Management

              • Online process VS M&A process; Roles, Work flow - Process Definitions, Timelines, Data Gathering ( SmarTeva)

              • Uncovering the different benefits of Master Data Management

            • 12:00 - 12:30
              • Speaker

                Kevin Devenny – Senior Clinical Data Manager, Boehringer Ingelheim
              • Boehringer Ingelheim

              Increase use of Endpoint Adjudication in clinical development programs

              • Uncovering the evolving role of the data manager and how the focus of their job is impacting upon what is required from them

              • Addressing the purpose and types of Endpoint Adjudication

              • Looking at the regulatory requirements and how this will impact upon the trials process

              • Considering the adjudication of Clinical Events

              • Improving processes by critiquing the key factors for selection of adjudication group

              • Enhancing efficiency - exploring the latest implementation strategies and technologies

              • Learning lessons - analysing experiences of different adjudication models

            • 12:30 - 13:45
              • Lunch and networking

              • 13:45 - 14:15
              • Exploring the current status of technology solutions used in the conduct of clinical trials today in order to gain insight for how to move forward

                • Addressing the ever-changing landscape of e-technology solutions to aid our understanding of how we are moving forward and what to expect

                • Evolving terms and definitions to gain insight into the more widely used and adopted language recognised by all industry players today

                • Establishing the importance of streamlining of systems in today's market to have technology products now working together as solutions, sharing data and eliminating duplication of tasks

                • Identifying techniques used by well recognised companies whereby combination of systems aids in the sharing of common data and reduced time spent on data input

                • Maintaining multiple systems effectively to prevent overlapping of data and discrepancies which may ultimately reduce data reconciliation

                • Providing significant workflow and process benefits for the end-user through use of convergence to create a single interface and seamless, highly optimised user experience

              • 14:15 - 14:45
              • EHR, Standardisation and Interface with EDC

                • Addressing electronic systems used in medicine: considering EHR - EDC

                • Uncovering issues concerning coexistence of these systems

                • Analysing a wish list for EHR

                • Considering a wish list for cooperation

              • 14:45 - 15:15
                • Speaker

                  Irving Dark – Vice President, Clinical Research Services, Cytel Inc

                Analysing software solutions to control and facilitate interim analysis data access, reporting, and communications between sponsors and Data Monitoring Committees

                Conference

                • Reviewing of international regulatory requirements for DMCs

                • Addressing increased responsibilities for sponsors of adaptive design trials

                • Identifying methods for building firewalls to protect sensitive data

                • Automating generation of supporting documentation for interim analysis and safety monitoring

                • Using online systems to better secure clinical data and build regulatory trust

              • 15:15 - 15:45
                • Afternoon refreshment break and networking

                  Conference

                • 15:45 - 16:15
                • Leading the Change in Clinical Data Management by Effective Use of Transformational Toolkits

                  • Methodology for Structured Innovation; Process, Technology, People

                  • Analysis of various business models for end customers

                  • Project Management techniques (Productivity, Quality and other Metrics)

                  • Establishing Cross-functional synergies between teams within CDM and with Biostatistics, Medical Writing

                  • Strategy for a long lasting and growing Customer relationship

                  • Effective Knowledge Management

                • 16:15 - 16:45
                  • Speaker

                    Nadir Ammour – Business & Technology Innovation, Sanofi Aventis

                  Considering an overview of the EHR4CR project - Electronic Health Records for Clinical Research

                  Conference

                  • Understanding how best to leverage EHR data - this offers large opportunities for the advancement of medical research, the improvement of healthcare, and the enhancement of patient safety

                  • Considering how the EHR4CR project will move beyond the current state-of-the-art by means of combining previously isolated informatics progress with an entirely new approach to develop a platform and business model for re-using EHR data for supporting medical research

                  • Evaluating the objectives of the project and what outputs can be expected • Addressing how best to organise such a project - what is the current progress and next steps that should be taken?

                  • Addressing challenges and ascertaining the program value and the benefits that it can have

                • 16:45 - 17:00
                  • Chairman's summation and close of day one

                Clinical Data ...

                Clinical Data Management

                  • 08:15 - 08:45
                    • Registration and refreshments

                      Conference

                    • 08:50 - 09:00
                      • Chairman's opening remarks

                        Conference

                      • 09:00 - 09:30
                      • Considering a case study: Understanding why to outsource data management and how to ensure efficiency and transparency with all involved

                        Conference

                        • Understanding the concept of outsourcing – the make or buy decision, tactical/strategic outsourcing, outsourcing models (full - functional)

                        • Improving efficiency by addressing the outsourcing process and how it should work

                        • Managing standard DM&Stat company requirements in a full service stand alone contract - RFP assumptions and description of activities

                        • Addressing the contracts key attachments - KPIs, risk management plan, communication plan

                        • Developing a standard approach between company and CROs in a functional DM&Stat MSA contract - the MSA structure, the Service Level Agreement, KPI setting and reporting, governance

                      • 09:30 - 10:00
                        • Speaker

                          Anne Van Vreckem – Associate Director Global Standards, Bristol-Myers Squibb
                        • Bristol-Myers Squibb

                        Case study: Interpretation and implementation of CDISC standards in the context of an existing effective standardization model

                        Conference

                        • Uncovering a real life example of how a pharmaceutical company have interpreted the CDISC standards

                        • Addressing changes and new approaches to standards that have become apparent in the past twelve months

                        • Analysing how the standards have been implemented in order to improve and enhance their current processes

                        • Discovering the correct time and stage to administer CDISC protocol through the exploration of where and when to best introduce them in the process of the trial

                        • Involving all the regulatory, medical, data management and statistic teams in order to implement and govern standards

                        • Encouraging the consistency of standards over time and how best to work as a united industry to promote simplicity

                        • Considering the importance of a standards working group - understanding how best to negotiate with senior management to obtain dedicated resource to create a standards working group

                      • 10:00 - 10:30
                        • Speed networking session

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

                            Conference

                          • 11:00 - 11:30
                          • Discovering protocol and GCP violations early and acting with power and common sense

                            Conference

                            • Addressing the origins of protocol and GCP violations

                            • Considering the limited efficacy of preventative measures

                            • Uncovering the methods for picking up problems early

                            • Looking at the closed loop: investigator – monitor – data manager

                            • Considering reaction algorithms that are in line with CAPA

                            • Examining current issues of cost-effective data quality

                          • 11:30 - 12:00
                            • Speaker

                              Dainius Ulpis – Senior Manager, Data Management, Mitsubishi Pharma Europe
                            • Mitsubishi

                            Ensuring the control of data and the maintenance of its quality by uncovering the most effective methods of managing quality and risk

                            Conference

                            • Guaranteeing the integrity of data by examining the most effective approaches to quality management

                            • Considering new and effective techniques of assessing the quality of data management from an ‘overall viewpoint’

                            • Understanding the impact of a risk based approach to data management and its impact upon the current processes and quality of data

                            • Minimising risk and securing the integrity of quality within the process

                            • Improving efficiency - evaluating remote monitoring of data onsite

                          • 12:00 - 12:30
                          • Underpinning the underpinning of CDISC – the Operational Data Model

                            • Overviewing how we Medidata use the ODM within our Concept to Conclusion (C2C) landscape, how others are using it and how we plan to use it moving forward

                            • Considering the Operational Data Model (ODM) and how it has served as the lingua franca for data and metadata exchange for CDISC and vendors since its debut

                            • Addressing the built in extensible Markup Language (XML) its flexibility and extensibility which has allowed it to serve as the core for both the SDS-CRT (Define.xml)

                            • Assessing the Study Design Model (SDM-XML)

                            • Exploring why most vendors support the ODM to varying degrees and why there have been a number of presentations of its utility for transferring data within and between systems

                          • 12:30 - 13:45
                            • Lunch and networking

                            • 13:45 - 14:15
                            • Case study: Building an effective outsourcing partnership with your service provider – encouraging transparency to ensure standards are enforced and quality is maintained

                              • Breaking down barriers with your outsourcing partner in order to ensure that there is the level of communication crucial to develop a healthy working relationship

                              • Limiting confusion - understanding the exact roles of each team member within the partnership

                              • Defining the standards necessary to ensure that the correct procedures are being employed

                              • Uncovering the best ways to stimulate transparency and understand exactly the day to day routine and protocol of your partner

                              • Ensuring that challenges can be quickly overcome - dealing effectively with any difficulties that might occur

                              • Uncovering things that have gone wrong in the past – overcoming the challenges that arise when tackling a difficult partnership

                            • 14:15 - 14:45
                            • Forecasting the Future of the Data Manager

                              • Addressing Lilly’s approach to data management and their approach to the challenging issues facing the industry

                              • Understanding how Lilly will attempt to mitigate losses in efficiency as the role of the data manager is shrouded by confusion

                              • Analysing the future of the data manager and what can be expected when planning strategies of further development

                              • Considering the new roles of the data manager and their likely priorities in the future – preparing for this challenge

                              • Understanding the likely regulatory requirements that will impact the role and necessary skills set of the data manager

                            • 14:45 - 15:15
                              • Speaker

                                Mark Rushton – Senior Manager, Clinical Data Management and Programming, Allergan

                              Case study: Maximising efficiency, maintaining control and reducing costs – analysing an effective model of in house data management

                              • Understanding alternatives to outsourcing by outlining a current in house model of data management

                              • Determining the best practices to encourage efficiency when dealing with data management in house

                              • Encouraging transparency and cooperation throughout the company to ensure that data management runs smoothly

                              • Outlining effective control measures whilst considering those currently used to ensure effective processes and communication

                              • Addressing priorities within the department to assess whether there are any potential tasks that could be outsourced without hindering the quality of the data and process

                            • 15:15 - 15:45
                              • Afternoon refreshment break and networking

                                Conference

                              • 15:45 - 16:15
                                • Speaker

                                  Adela Pau – Clinical Data Manager, Almirall

                                Ensuring quality of data from your outsourcing partner - developing a more thorough process to guarantee a coherent set of standards

                                • Overcoming uncertainty and developing a coherent set of standards to encourage transparency between pharmaceutical companies and their outsourcing partner

                                • Understanding the additional benefits of exactly what can be gained from developing a clearer set of standards when outsourcing to a service provider

                                • Uncovering the best means of communicating effectively when establishing processes and dealing with problems

                                • Developing concrete roles within the partner teams so stimulate a more standardised and effective process

                                • Standardising day to day tasks to ensure that the quality specified by the pharmaceutical companies is adhered to

                                • Improving efficiency and maintaining quality – considering the monitoring processes in data management

                              • 16:15 - 16:45
                              • Future of Statistical Program: Impact on Data Management

                                • Considering the current situation of Statistical Programming

                                • Addressing collaboration with Data Management: so close yet so far

                                • New Data, New Systems...New World

                                • Uncovering the road to a better collaboration between both functions

                              • 16:45 - 17:00
                                • Chairman's summation and close of day one

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