1. 1 Are we ready for an audit/inspection as a CRO? Clinical Research Association Istanbul – 01DEC2007 Tony Owen, Vice-President QA Europe

2. 2 Content  What are my credentials?  Quintiles Experience  When do you start preparing?  Quality Management System  Who’s your best friend internally?  Internal QA programme  What to do when the inspection is announced?  Preparation for audit/inspections

3. 3 Quintiles - Inspection Experience in Europe (2007 to date)  1999 – 5  2000 – 16  2001 – 21  2002 – 26  2003 – 41  2004 – 23  2005 – 13  2006 – 42  2007 – 60  2006 first inspection in Turkey  FDA Investigator Site Inspection  No FD483 Inspectors are like busses! You never know when the next one will arrive!

4. 4 Quintiles inspection experience - With various inspection agencies (end 2Q07)

5. 5 Quality Management System  Regulations  SOPs  Training and development  Validated computer systems  Management oversight  Quality Control  Quality Assurance  Records of all the above When do you start preparing for an inspection? “There is no time like the present.”

6. 6 Internal QA Programme  QA - Service function  QA Services  Audits  Metrics  Quality Issue management  Consultancy – quality related queries  Host customer audits/ regulatory inspections  Training (some)  Quality Planning  QA Leads QA is your best friend!!!

7. 7 Internal Audit Programme  Audit All Pivotal studies  As a minimum:  Quality Planning Team meetings  In Trial  2 In Depth Site Audits per project  Additional projects can be included in the internal audit programme as deemed necessary by QA.  Non-pivotal studies - occasional telephone audits  Process and computer systems audits Internal audit programme to complement the sponsor audit programme, not replace it

8. 8 Audits - Do different types to drive improvement e.g.:  Scorecard audits  Select Key Performance indicators  Audit across offices  Score the results and publish  Develop action plans  Repeat to drive improvement  Telephone audits  Interviews with groups of CRAs  Set questions  Publish – this is what you need to know about your st

9. 9 Metrics - Make the most of information you have  Collate audit data  Enter into a database  Produce regular operational metrics  Analyse findings – introduce preventive actions  Drive improvement

10. 10 Quality Planning - Prepare for inspection before study starts!  QA, PM, CTL, Medical Advisor, Regulatory Affairs, others  “What could kill this study in an inspection?” e.g.:  Cannot demonstrate correct diagnosis  Efficacy measures inconsistent  Supplies not stored correctly  Identify the risks e.g.:  For each key diagnostic, efficacy and safety test  What equipment/experience is required?  How will this be communicated and documented?  What consistency checks are required to be performed?  What evidence will be required?  Mitigate the risk  Plan, instruct, monitor correct

11. 11 What to do when an inspection is announced!  Prepare sometimes - It’s not always sensible/possible!  Low risk  Brief investigator site inspections  e.g. Germany, Greece, Hungary, Bulgaria  Intermediate risk  More intensive site inspections, may include visit to sponsor/CRO facilities  e.g. France, Italy, Finland, Ireland, Austria  High risk  Intensive, sites and sponsor/CRO facilities  Evaluation of sponsor/CRO processes  Can extend into other parts of business  e.g. EMEA, FDA, UK-MHRA The last chance saloon!

12. 12 A Possible Strategy for Inspection Management

13. 13 Quintiles Preparation - Intermediate and High Risk Inspections  QA pre-inspection (as soon as possible)  Focus on processes, computer systems, and projects  Interview staff and review documents  Agree action plan  Follow up on actions  Place third parties on stand by  Train staff in handling inspections  Encourage staff in their knowledge and abilities

14. 14 Thank you!