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.
TiumBio files Clinical Trial Application to start Phase 1b TU7710 study
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
argenx obtains VYVGART approval for primary immune thrombocytopenia in Japan
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval