Dedicated
Three dedicated project management tracks: Clinical Trial Oversight, Biosample Operations Management and Biomarker Analysis Management.
Oversight
Clinical trial oversight specialized in early-phase clinical trials, including First-in-Human (FiH) studies with focus on project- and CRO oversight.
End to End
Sponsor-representative project management support across vendor selection and oversight—from set-up through close-out.
Quality
Quality-first delivery aligned with GCP and regulatory expectations.
What is the hVIVO Bio-Sample Project Management service?
Trial oversight and biosample operations and biomarker analysis management are services that oversee the processes and suppliers required to execute specific parts of the clinical studies—covering clinical execution, biosample logistics and outsourced biomarker measurement oversight.
hVIVO’s model focuses on acting as a sponsor representative across selection and oversight of vendors, while managing core trial controls such as timelines, budgets, risks and reporting requirements.
How it Works
Clinical Trial Oversight
Clinical Trial Oversight is a regulatory requirement a sponsor needs to ensure for sponsor responsibilities that have been transferred to a CRO. CRO oversight starts with the set-up of a CRO oversight plan to confirm responsibilities, processes, deliverables and escalation paths. Our oversight process includes two focus area’s: project mandated- and CRO oversight driven meetings and reports both to ensure that business expectations are met and the trial results are delivered on time and within budget.
Biosample Operations
Plan and oversee collection, storage and shipment of human bio-samples to assay laboratories; reconcile logistics records and manage deviations, all to ensure timely delivery and optimal analysable quality. These activities include all project phases: from central logistic lab, budgeting and contracting, clinical trial protocol and eCRF review for required (lab) specifications, study kit design, lab manual review, bio-sample shipment coordination and reconciliation, to close out activities (final shipment to the analytical labs, disposal of bio-samples as applicable, and archiving).
Biomarker Analysis Management
Ensures the setup and monitoring of external biomarker analyses within clinical studies to achieve comprehensive, high-quality biomarker data sets which are critical for data-driven decision-making in clinical development projects. The activities include all project phases: vendor selection and qualification, contracting, budget oversight, reviewing validation plans, biomarker analysis plans and reports, monitoring biomarker analyses, issue management during analyses, up to project closure (data transfer of analytical results and archiving). All these activities ensure high quality and regulatory compliance in all aspects of outsourced biomarker analysis.
Our Capabilities
- Clinical trial oversight: full oversight from set-up to close-out focusing on the project as well as CRO performance.
- Biosample Operations Management: global coordination and logistics for human biosamples across Phase I–IV trials (e.g., PK and immunogenicity samples, biomarker samples, biobanks).
- Biomarker Analysis Management: governance of outsourced biomarker measurements, including contracting/budgeting and oversight of scientific, technological and regulatory requirements.
Our Experience
Delivered on-time trial set-up through close-out for an early-phase programme, coordinating site selection, vendor oversight, and governance across workstreams.
Managed global bio-sample logistics for a multi-centre study, including reconciliation and deviation management to protect sample integrity.
Oversight of outsourced biomarker measurement programme, aligning validation and reporting to ensure high-quality biomarker datasets for decision-making.
Ready to de-risk your early clinical study?
Speak to hVIVO’s project management team about clinical trial oversight, biosample operations and biomarker analysis oversight.
