In recent years we have undergone several stringent audits by international clients with particular emphasis on our SOPs, and QC and QA systems. In addition, at our request, the Irish Medicines Board has subjected us to a voluntary GCP inspection. In each case, we emerged with flying colours. Independent auditors from Europe and the USA have expressed their satisfaction with the unusually strict standards applied at Shandon Clinic. These standards are maintained through frequent scientific briefing sessions and exchange of views between colleagues and clients from several countries. Copies of representative inspections are available on request.
Shandon Clinic collaborates with approved partners who analyse safety bloods and assay plasma samples for kinetic purposes. These laboratories have been subjected to audits by ourselves, by selected clients, by independent auditors and by European and US regulatory authorities. Each of our bioanalytical partners has specific expertise in method development. Careful project management ensures that methods are validated well before the clinical phase of a kinetic study is complete. Current lists of validated methods are available on request.