Oncologica, a leading precision oncology profiling company and Contract Research Organization (CRO) in the pharmaceutical industry, has chosen Arkivum Trust, to provide an integrated long-term data management solution. Arkivum will support Oncologica in managing its regulated genomics and patient data, generated by Thermo Fisher’s Ion GeneStudio S5 next-generation sequencing (NGS) system.
Oncologica develops precision oncology solutions to personalize cancer treatments. The CRO achieves this by identifying individual genetic biomarkers, which are used to match individual patient tumours to specific medicines. Oncologica uses the Ion GeneStudio S5 system to run tests and record genomic sequence data efficiently.
Dr Marco Loddo, Co-Founder and Scientific Director at Oncologica says: “As a CRO, we need to demonstrate stringent data management and safeguarding practices to our existing and prospective clients in the pharmaceutical industry. Thanks to Arkivum and Thermo Fisher, we can focus our team on core pharmaceutical activities, knowing that the data is secure, usable, shareable, and compliant throughout its lifecycle. Arkivum provides our sponsoring organizations with the data they need, in neat, structured packages. This helps us demonstrate our value as a professional, long-term CRO partner.”
Arkivum is providing an integrated solution that meets the data requirements of Thermo Fisher’s Ion GeneStudio S5 system users such as Oncologica. A secure transfer mechanism migrates the sequencing data into the Arkivum Trust platform, where the data is safeguarded, indexed, preserved, and made usable according to the CRO’s data policy procedures.
Arkivum Trust makes Oncologica’s regulated data discoverable and accessible whenever needed. Ion GeneStudio S5 users are able to search for data managed by Arkivum, share it securely, and import it back for further analysis and experimentation.
As Oncologica expands its business, it needs to comply with a diverse range of regulatory bodies. Oncologica was satisfied that with its international client base, Arkivum would be able to manage the sensitive data in compliance with worldwide standards and regulatory bodies, such as MHRA GxP Data Integrity Guidance and FDA 21 CFR Part 11, 210 and 211. Oncologica was particularly reassured by Arkivum’s GDPR-compliant processes, as the CRO frequently needs to extract data in response to patient requests.
Guy Yaniv, CEO of Arkivum, concludes: “Life science organisations such as Oncologica are fast becoming big data enterprises. In a climate of intense regulatory scrutiny and the growing need to understand, share and collaborate with data, we are thrilled to be able to help Oncologica achieve those requirements and deliver value. Through our collaboration with Thermo Fisher, we have jointly delivered a pre-integrated solution for next-generation sequencing data that lifts away the responsibility for data preservation and safeguarding at scale.”
If you would like to find out how we can help with your Next Generation Sequencing data or other long-term data management need get in touch.
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