Quality Assurance

Shandon Clinic has a longstanding commitment to the maintenance of high quality in the performance and reporting of studies. There is ongoing investment in training of personnel and in the dynamic improvement of services and standards. Members of staff retain an interest in academic research, and attend and present original work at international conferences.

All study-related tasks are subject to in-house QA procedures to ensure compliance with ICH Good Clinical Practice, and with the EU Clinical Trials Directive 2001/20/EC. This includes:

Study protocols, CRFs, study procedures, SOPs, data management
Study medication handling
Pre-study, interim and post-study audits
Study report auditing
Systems audits


Audits

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.

Collaborating laboratories

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.

 

 
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