Software and data management services provider, Arkivum, will store Idorsia’s data on an e-archive to manage and secure access to this data in the future.
Headquartered near Basel, Switzerland, Idorsia Pharmaceuticals focuses on clinical research and development of small molecule therapeutics. Idorsia was separated from Actelion after the latter was acquired by Johnson & Johnson in 2017.
According to Arkivum, following the separation, Idorsia had an ‘urgent requirement’ to manage data returned from contract research organizations (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,” Arkivum stated.
Additionally, due to regulatory requirements, the data needed to be actively preserved and managed to enable long-term readability and access.
Clinical and regulatory records manager at Idorsia, Simon Souster, said that the company was “looking for the confidence that in 20, 30, 50 years we will be able to provide evidence if an auditor comes in and asks to see all documentation relating to a specific product or clinical trial.”
A spokesperson for Arkivum told us that the company has worked to define the data structures of Idorsia, which is currently doing a final internal preparation to ingest their data before the e-archive goes 'live'.
An e-archive to maintain compliance
According to Arkivum, the realization of the e-archive provides a life sciences company with the ability to continue to meet regulatory compliance.
"Digital content poses a far greater risk, generally, than paper based records so it’s vital to be able to provide full audit reports and be able to easily (and quickly) extract the complete data package containing the raw data, accompanying metadata and full audit trails to report to regulators," a spokesperson for Arkivum told us.
Concurrently, according to the spokesperson, this data storage and management service allows the company to improve the searching, collaboration, reusability and long term preservation of the content.
Specifically in the case of Idorsia, who was formed through a demerger, there was 'huge pressure' to get their data migrated and under control quickly, the spokesperson said.
According to Arkivum, "Idorsia still needs to meet the regulatory requirements for data and record keeping, including ALCOA+ principles."
"The main requirements are to be able to create data packages that contain the raw data, all associated metadata and the full audit report, and be able to provide secure controlled access to support Idorsia’s compliance processes and deliver GxP compliance throughout the lifetime of the data."