General Information

 

Drug Research Centre is a full function CRO with a prime objective of supplying our customers and health authorities the highest standard of drug evaluation and bioequivalence studies.

Drug Research Centre operates state-of-the-art facilities specializing in method development and validation, and analysis of drugs and metabolites in plasma, blood and urine from clinical trials and preclinical projects

Drug Research Centre has a proven record for flexible service and accurate results. We are serious about our science and are devoted to our client relationships.

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 2.    Documentation:

The Following documents are well written in files added in and available on CD:

1-     Approved protocol of the bioequivalence study.

2-     Synopsis of protocol of the bioequivalence study.

3-     The required specifications for the laboratory staff (SOP and Job description)

4-     Written signed contract between the sponsor and the laboratory

5-     Written informed consent (Arabic and English) which should be signed by the volunteer & responsibles.

6-     Case report form.

7-     Clinical laboratory tests and physical examination, or any additional required examination for the volunteers (performed by professionals in registered hospital and/or registered laboratory).

8-     C.V. of  DRC staff.

9-     Computerized equipment^, programs, manuals, certificate of calibration and their C.D.

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3. Personnel

 

Staff of DRC include:

1.      Chairman of Board.

2.      Vice Chairman of Board.

3.      Technical Manager. (PH.D.)

4.      Head Manager.

5.      Secretary & Document controller.

6.      Principal Investigator (PH.D.)

7.      Clinical Investigator (MSc.)

8.      Analytical Investigator

9.      Quality Control Unit Manager (MSc.).

10. Quality Assurance Unit Manager

11. Human Resource Department

12. Laboratory Supervisor (MSc.)

13. Laboratory Analysts (Pharmacists & Chemists)

14. Medical Staff (Nurse, Physician(s), Clinical Investigator)

15. Volunteers Responsible

16. Purchasing Department

17. Labor(s)

18.Security personnel

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4. DRC - Pharmaceutical Companies Profile: