Programme

Chairman's opening remarks

Morning refreshments and networking

Lunch and networking

Afternoon refreshment break and networking

Chairman's summation and close of day one

Chairman's opening remarks

Conference

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

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

Speed networking

Morning refreshments and networking

Conference

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

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

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

Lunch and networking

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

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

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

Afternoon refreshment break and networking

Conference

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

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

Chairman's opening remarks

Conference

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

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

Speed networking session

Morning refreshments and networking

Conference

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

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

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

Lunch and networking

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

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

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

Afternoon refreshment break and networking

Conference

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

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