Aspire Pharma: Complying with EU Reg 536 Retention Requirements
Aspire Pharma Limited (APL) is a medium size pharmaceutical company, based in the UK. Incorporated in 2009, APL is committed to making a valuable difference to patients, healthcare professionals and the NHS through their range of medicines and medical devices.
As part of the licensing and development of their products, APL are required to conduct clinical trials. These trials are generally small bioequivalence trials in healthy patients, so the data sets produced are consequently small. Previously, 1 to 2 clinical trials have been sponsored each year by APL, who act solely as a remote sponsor. The activities of the clinical trial are carried out by specialised contract research organisations, of which APL retains oversight. As a result of being within a heavily regulated industry, APL require a solution to store clinical trial data that ensures GxP and regulatory compliance over a long period.
Discover how Aspire Pharma partnered with Arkivum to ensure GCP and regulatory compliance.
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