General Services

It is difficult to present a detailed listing of the individual aspects of ay research contract, but it certainly is possible to summarise these in a short list from which the contractor can select those services which will be most relevant to the conduct of his potential programme.

• Study preparation

            Protocol design

            CRF design

            Clinical trial approval

            CRF review/coding

            Site selection/Investigator selection

            Translation of relevant documentation

• Clinical efficacy and safety

           Phase I-IV studies

           Hospital in-patient/out-patient

           Volunteer studies

           First administration to man

           Multinational studies

           Monitoring

• Bioavailability/Bioequivalence studies

          Pharmacokinetics

          Monitoring

          Statistical analysis

          Data management

          Report writing

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