Oncologica, a Leading CRO, Selects Arkivum for Integrated Long-Term Data Management of Next-Generation Sequencing Data

Oncologica develops precision oncology solutions to personalize cancer treatments. They achieve this by identifying individual genetic biomarkers, and matching individual patient tumours to specific medicines. Oncologica uses the Ion GeneStudio S5 system to run tests and record genomic sequence data.

Dr Marco Loddo, Co-Founder and Scientific Director, Oncologica says: “As a CRO, we need to demonstrate stringent data management and safeguarding practices to existing and prospective clients. Thanks to Arkivum and Thermo Fisher, our team can focus on core pharmaceutical activities, knowing that data is secure, usable, shareable, and compliant throughout its lifecycle. Arkivum provides our sponsoring organizations with the data they need, in neat, structured packages, helping us demonstrate value as a professional, long-term CRO partner.”

Arkivum is providing an integrated solution that meets data requirements of Thermo Fisher’s Ion GeneStudio S5 system users such as Oncologica. A secure transfer mechanism migrates sequencing data into the Arkivum platform, where data is safeguarded, indexed, preserved, and made usable according to Oncologica’s data policies.

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 re-import for further analysis and experimentation.

As an expanding CRO Oncologica needs to comply with a diverse range of regulatory bodies. Oncologica was satisfied that Arkivum’s international client base meant they are able to manage sensitive data in compliance with world-wide 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 they frequently receive data access requests from patients.

Guy Yaniv, CEO, Arkivum, concludes: “Life science organisations are fast becoming big data enterprises. In a climate of intense regulatory scrutiny and growing need to understand, share and collaborate with data, we’re thrilled to help Oncologica achieve this and deliver value. Through collaboration with Thermo Fisher, we’ve jointly delivered a pre-integrated solution for NGS data, releasing responsibility for data preservation and safeguarding at scale.”

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