Enhancing the CRO-Sponsor Collaboration to Ensure High Quality of Clinical Data

1. Enhancing the CRO-Sponsor Collaboration to Ensure High Quality of Clinical Data May 17,2011 | Beijing, China Charles Yan, PhD Shanghai Clinical Research Center

2. Agenda • Potential Advantages and Risks for Outsourcing • Outsourcing for Clinical Data Management • Considerations in Selecting a CRO • KeyFactors for High Data Quality • Best Outsourcing Relationship www.diahome.org

3. Potential Advantages for CROs • Reduce: • Time to develop and commercialize a new drug • Sponsor’s fixed costs with personnel, equipment and facilities needed for its clinical development • Provide: • Ready access to needed expertise and/or technology • Greater access to potential investigators • Knowledge of regulatory climate in foreign markets www.diahome.org

4. Potential Risks of Outsourcing to CROs Reduced control of the clinical trial process by the Sponsor • Delays in completion of studies • Lost or poor dataquality • Regulatory infractions produce indirect consequences • FDA regulations/GCPs • Fraud and Abuse • IP

5. Outsourcing for Clinical Data Management • Electronic Data Capture • Site User Training, Administration and Support • EDC： Site Guides Data Management Plan CRF Design, Annotated CRF Database Setup and Edit Check Development Data Entry and Discrepancy Management Lab Data Management AE/SAE Management Coding (MedDRA + WHO DD) Database Locking QC and QA www.diahome.org

6. Considerations in Selecting a CRO • Company information • Historical overview of the organization, • Length of time in the industry, • Financial stability of the organization • Organizational structure • Products and services • Experience • Product demonstration • Commercial – Business sustainability – Cost of services www.diahome.org

7. Considerations in Selecting a CRO Compliance – Understanding of global regulations(FDA, SFDA, etc) – Archiving system – Quality systemsand proof of compliance to their quality requirements – Quality assurance Documentation of system validation for regulated processes Evaluation of the vendor’s QC/QA process Disaster/contingency plan(s) to protect business operations Adaptation to sponsor’s SOPs Results of previous regulatory inspections www.diahome.org

8. Considerations in Selecting a CRO Capacity and Flexibility – Expansion with changing needs – Resources to deal with uncertainties – Handling additional assignments Capability and Credibility – Diversity of experience – Experienced people – Adequate facilities – Training and incentives for people Confidentiality www.diahome.org

9. Considerations in Selecting a CRO Documentation change control processes Review of required accreditation Personnel qualification, job descriptions, organizational charts, training plans etc. Data transfer process References from previous customers Outcomes of previous regulatory inspections Security of physical locations where services are provided (server rooms, file rooms, etc.) The number of sponsors or studies currently supported by the available CRO staff www.diahome.org

10. KeyFactors for High Data Quality • Detailed start-up meetings （ face-to-face） • Overview of the whole program • Ensure that processes for both companies are described in detail (SOPs and training) • Define the roles and responsibilities for sponsor and CRO • Discuss expectations of both teams in regard to deliverables, timelines and resource • Communication and decision-making strategy • Issue resolution process • Budget planning and management • Expectations and performance metrics

11. KeyFactors for High Data Quality The Most Common Sources of Conflict In recent industry survey, both Sponsor and CRO agree that the topsources of conflict are related to mismatchedexpectations. – Pharma: 88% agree – Service Providers: 92% agree www.diahome.org

12. KeyFactors for High Data Quality Define Acceptable Metrics in Data Management （Time, Cost, Quality and Quantity) www.diahome.org

13. KeyFactors for High Data Quality At Study Setup Phase To clearly define the roles and responsibilities for DM CRO www.diahome.org

14. KeyFactors for High Data Quality At Study Conduct Phase To have a good communication channels (weekly basis or as needed) www.diahome.org

15. KeyFactors for High Data Quality At Study Closeout Phase To follow database lock procedures and to lock database on time www.diahome.org

16. Best Outsourcing Relationship • Understand, learn and respect each other • Careful selection and detailed contract vital for along term successful relationship • Sponsors need to carefully assess therequirements of CRO • CRO needs to understand expectations ofsponsor • Mutual benefit from the relationship • Support from senior management • Set measurable goals and objectives • Performance measurement and feedback • Periodic, formal and fact-based relationship • Progress review process in place • Communications and conflict resolution process • Feedback and evaluation www.diahome.org

17. Thank you! • Q&A Contact info: chongchao.yan@scrcnet.org www.diahome.org