Clinical Trials

Be assured that your clinical trials will be translated accurately

Clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions, which may include placebo or other control, to evaluate the effects of those interventions on health-related biomedical or behavioural outcomes.

To successfully translate medical trials we select the best resources for each of the following phases:

Phase I – Testing of drug on healthy volunteers for safety and dose-ranging.

Phase II – Testing of drug on patients to assess efficacy and side effects.

Phase III  Testing of drug on patients to assess efficacy, effectiveness and safety.

Phase IV – Watching drug use in public. 

More information

Subject matters

  • biologics
  • biomedical and behavioural interventions
  • diagnostic strategies
  • treatment strategies
  • prevention strategies
  • drugs, small molecules, compounds
  • vaccines
  • implamentable medical devices
  • surgical techniques

Documents

Documents for investigators:

  • investigator's brochure
  • study protocol
  • case report forms (CRFs)

Documents for patients:

  • patient information sheet
  • informed consent form
  • emergency cards

Documents for regulatory authorities:

  • study reports
  • reporting on adverse events,
  • PSUR, DSUR
  • audit inspection documents