Quality of work at BAST is controlled through:
4-month training course for all staff (regardless of experience) upon commencement of employment at BAST. No work on client projects is allowed until all parts of the course have been examined and satisfactorily completed. Unsatisfactory completion leads to termination of employment by BAST. Each part of the course is supervised by senior BAST staff and concludes with an oral examination. Training course content:
- Good Clinical Practice
- Theory: pharmacokinetics, pharmacodynamics, non-linear mixed-effects modelling
- Software: R programming language, NONMEM
- BAST Quality Documents and processes
- Three modelling and simulation case studies to work through in detail
Adherence to procedures described in 22 Quality Documents (can be provided on request).
All BAST staff maintain Laboratory Journals.
Monthly “Risk Awareness” meetings where all matters relating to quality of work, regulatory guidance, IT systems and continuous improvement are discussed and documented.
BAST has recently (Q2 2021) undergone a full GCP audit by an independent contractor, which revealed no material issues in the BAST QA process.