Arkivum today announced that Idorsia Pharmaceuticals, headquartered near Basel, Switzerland; has selected Arkivum to safeguard and digitally preserve their valuable research and clinical trial data. A relatively new company born out of a de-merger of Actelion (who were bought by Johnson and Johnson); Idorsia has been created as a completely new company and required an e-archive solution to not only store a large amount of its data but also to provide secure access for future use. The data includes previous Actelion data, data relating to inherited products returning from CROs and service providers, as well as data being generated by Idorsia itself.
Idorsia had an urgent requirement to actively manage data that is being returned from CROs in relation to products and compounds inherited from Actelion. Such external service providers have had a mandate to hold data for 10 years and due to the age of these inherited products this data is starting to be returned to Idorsia and needs to be archived. Due to regulatory requirements, the data needed to be actively preserved and managed to enable long-term readability and access.
Simon Souster, Clinical and Regulatory Records Manager at Idorsia says: “We were looking for the confidence that in 20/30/50 years’ time we can provide evidence if an auditor comes in and asks to see all documentation relating to a specific product or clinical trial; proving the integrity, chain of custody and the audit trail of our data”
All pharmaceutical companies, including Idorsia, have a regulatory requirement to keep key GxP records (eTMF data, clinical study reports, lab notes etc) for the long term, in some cases indefinitely. During that time, it is mandated that regulatory authorities are able to have readable access to the archive for regulatory audit purposes etc and be able to reconstruct a clinical trial should there be a question about one of their products or trial processes years down the line. Therefore, the main driver behind this project was around record retention and ensuring 100% data integrity. Idorsia needed a product which completely protects the integrity of the data, ensuring it is tamper-proof whilst allowing easy access and re-usability.
Arkivum will be providing Idorsia with a fully managed service, including working with Idorsia to define their data structures and processes in relation to the long-term management of their data.
George Waidell, Global VP of Life Sciences says: “We are delighted to be working closely with Idorsia to provide their long-term data management and preservation system, particularly as Idorsia are building new ways of working with their long-term data putting them at the forefront of what the Pharmaceutical sector is doing in this area.”
Simon concludes “We were especially impressed with Arkivum’s flexibility and willingness to learn together. There are not a lot of pharma companies that have an e-archive, and because of that there aren’t many supplier companies that have the GxP knowledge or understanding of the compliance requirements we need to adhere to, such as CFR 21. Arkivum have impressed us with their flexibility and expertise and have proved a good vendor to work with as we look to build our archiving processes”.
About Idorsia Pharmaceuticals
Headquartered near Basel, Switzerland – a biotech-hub of Europe – Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of over 700 highly qualified specialists dedicated to realizing our ambitious targets, a fully functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.
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