Policy & Regulation
Oncologica Selects Arkivum for Integrated Long-Term Data Management of Next-Generation Sequencing Data
23 May 2019 - - UK-based precision oncology profiling company and contract research organisation Oncologica has chosen UK-based Arkivum to provide an integrated long-term data management solution for regulated genomics and patient data, the company said.

Data is generated by Thermo Fisher's Ion GeneStudio S5 next-generation sequencing system.

Oncologica develops precision oncology solutions to personalise 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.

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.