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Are we ready for an audit/inspection as a CRO?

Clinical Research Association

Istanbul – 01DEC2007

Tony Owen, Vice-President QA Europe

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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

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Quintiles- Inspection Experience in Europe (2007 to date)

1999 – 5 1999 – 5 2000 – 16 2000 – 16 2001 – 21 2001 – 21 2002 – 26 2002 – 26 2003 – 412003 – 41 2004 – 232004 – 23 2005 – 13 2005 – 13 2006 – 422006 – 42 2007 – 602007 – 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!

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

35 Agencies conducting 228 Inspections

11%

11%10%5%5%5%5%

5%

4%

4%

4%

4%

27%

German RA Darmstadt

FDA

Greece EOF

EMEA

Hungarian Inst. Of Pharmacy

UK MHRA

Independent Audit for EMEA

Israel MOH

Bulgarian National Drug Inst.

Israel LEC

Spanish MOH

Italian MOH

Others National Agencies

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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.”

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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!!!

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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

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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

1 2 3 4 5

Category P

Category N

Category L

Category J

Category H

Category F

Category D

Category B

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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

Average for Last Four Quarters, Q2 2006 to Q1 2007 (European Average = x)

Ave

rage

No

of F

indi

ngs

0

No

of

Rep

ort

s

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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

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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!

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A Possible Strategy for Inspection Management

Pre-inspection

Preparation of site staff

Attendance Preparation of Response

Low risk CRA Visit to site where possible

CRA, if possible

No (Not normally

possible)

If possible

Intermediate QA to site if lead time permits

QA

Yes (Where

possible)

Yes

High Risk QA to site and ancillary

facilities

QA

Yes Yes

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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

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Thank you!