Good Clinical Practice and GCLP (including. PK Bioanalysis)

We have worked on a variety of projects and therapy areas in the clinic, with a concentration on oncology.

The emphasis has been on new molecules progressing into the clinic, often with a continuous QA contribution from Discovery through IND/CTA to advanced clinical trials involving IVRS and blinding. Below is an indication of the GCP areas covered

  • We have audited GCP CROs (TMFs/Pre-approval) and clinical sites in Europe, Ukraine and Russia, with some inspections in USA.

  • We have inspected clinical and marketed product packaging and bioanalytical sites throughout EC/USA.

  • We assist clients in compilation and review of INDs (Investigational New Drug - USA)/CTAs (Clinical Trial Applications – EC) and regularly assist in compilation of regulatory Amendments.

  • Most clinical inspections have been carried out on phase I/II with some phase III.

  • We work either directly for clients or through intermediate CROs.

  • We review IBs (Investigator Brochures) protocols and amendments for on-going clinical programmes.

  • We have extensive experience of clinical bioanalysis requirements, including Validation, analytical plan review and report audit for FTR (Final Trial Report) compilation.

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