What we work to when preparing the report and the action plan
The requirements we assess against, the format in which findings are presented, and the deadlines the action plan is tied to.
National legislation
We work to the law as it stands on clinical trials and on how healthcare facilities run them: the Fundamentals of Healthcare Legislation, the Law on Medicinal Products, MoH Order No. 690 together with the ethics committee regulation, medical practice licensing conditions, and the rules on metrology and personal data — in their current wording.
International instruments and industry standards
ICH E6 Good Clinical Practice, the Declaration of Helsinki, Good Clinical Laboratory Practice and ISO 15189 for laboratory diagnostics — the basis on which sponsors and CROs assess a site in any country.
Findings from inspections
We work from inspection and sponsor audit reports, which set out where sites most often fail. Those areas are examined specifically when we prepare our own report.
Long practice in clinical trials
The report is prepared by specialists with long practice in clinical trials, who know both how a requirement reads in a document and how it applies in the daily work of a site.
Tell us about the facility and we will say where to start
A short call commits you to nothing. After it you will know the scope of the work and its cost, even if you decide to do everything in-house. We reply within one working day.