Idorsia, which is born out of an Actelion de-merger, selected Arkivum’s e-archives platform to store its data, as well as to offer secure access for future use.
The data that needs to be stored includes previous Actelion data, information relating to inherited products returning from CROs and service providers, and the data the company itself generates.
Idorsia had received data from its CROs relating to the products from Actelion and the company needed to store the data for an extended period.
Idorsia Clinical and Regulatory Records manager Simon Souster said: “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”
Arkivum will work with Idorsia to outline their data processes and structures to aid in the long-term management of their data.
Simon added: “There are not many 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”.
In 2017, Idorsia reported positive results from a Phase II programme of ACT-541468 to treat patients with insomnia.
ACT-541468 is a dual orexin receptor antagonist (DORA) designed to target the orexin system to maintain natural sleep pattern.