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20 February 2006

Who is involved in contract research?

Pharmaceutical companies can do their own research or contract the research out to a Contract Research Company (CRO).

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Pharmaceutical companies can do their own research or contract the research out to a Contract Research Company (CRO).

The CRO is responsible for the process of managing the clinical trial, providing scientific evaluations and analysing the results according to good clinical and laboratory practices as required by regulatory authorities.

Investigators (doctors doing the clinical trial) are chosen according to their expertise and previous trial experience.

Patients are chosen according to the inclusion and exclusion criteria of the protocol and whether they are willing to give informed consent to participate in a trial.

Study Site Coordinators are registered nurses trained to do clinical trials and can be very valuable to an investigator to organise the site and to do most of the administrative work.

Individual Ethics Committees and the Medicine Control Council review all clinical research protocols before allowing an investigational drug into the country or any distribution for human use.

Bets Breedt, MBChB, B Med Sci, M Fam Med
Manager Investigator Services: Quintiles

References:
1. Code of Federal regulations.
2. International Conference on Harmonisation guidelines.
3. Ken Flieger. Testing drugs in people. FDA Consumer July-August 1994.
4. Joanne Kabak. Clinical Trials: How drugs get from the test tubes to us. Drkoop.com:Family:Features.
5. T.A.M. Kramer. Drug Development. Medscape Psychiatry & Mental Health eJournal, 24 July 2002.

 
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