Oncologica, a leading precision oncology profiling company and Contract
Research Organization (CRO), has chosen Arkivum to provide an integrated
long-term data management solution for regulated genomics and patient
data. Data is generated by Thermo Fisher’s Ion GeneStudio S5
next-generation sequencing (NGS) system.
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.”