Aspire Pharma: Complying with EU Reg 536 Retention Requirements
You can access the full Aspire case study here.
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.
Access the full story here.
Ready to find out more?
Submit your details below for a personalised demo showing how your organisation could be benefitting from long-term data management today. Fields marked with an * are required. Need more information? See our blog or contact us.
09 Nov, 2022
eTMF retention requirements: complying with EU Regulation 536/2014
07 Feb, 2023
Inspection Time: Results of the GCP IWG 2021 and how to improve your results for 2023
16 Feb, 2023