hVIVO provides dedicated project management services for clinical studies, with clinical trial oversight for early-stage clinical trials, and biosample operations and biomarker analysis management for the whole clinical landscape, all to keep your programme on time, on budget and compliant.
Three dedicated project management tracks: Clinical Trial Oversight, Biosample Operations Management and Biomarker Analysis Management.Challenge Study Models
Clinical trial oversight specialized in early-phase clinical trials, including First-in-Human (FiH) studies with focus on project- and CRO oversight.
Sponsor-representative project management support across vendor selection and oversight—from set-up through close-out.
Quality-first delivery aligned with GCP and regulatory expectations.
Extend your team with experienced project leadership, vendor oversight and risk management without building internal infrastructure.
Add flexible capacity for complex workstreams like global sample coordination and logistics, biomarker outsourcing to protect sample integrity and produce usable, compliant datasets, while maintaining strong governance.
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.
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.
Plan and oversee collection, storage and shipment of human biosamples to assay laboratories; reconcile logistics records and manage deviations, all to ensure timely delivery and optimal analyzable 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, biosample shipment coordination and reconciliation, to close out activities (final shipment to the analytical labs, disposal of biosamples as applicable, and archiving).
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.
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.
Early-phase focus: clinical project managers experienced in early development and First-in-Human trials.
Quality & compliance: prioritises GCP-aligned delivery with robust documentation and oversight across sites and vendors.
Sponsor-minded execution: acts as a sponsor representative to streamline decision-making, communication and accountability across stakeholders.
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 biosample logistics for a multi-centre study, including reconciliation and deviation management to protect sample integrity.
Oversaw outsourced biomarker measurement programme, aligning validation and reporting to ensure high-quality biomarker datasets for decision-making.
Support can cover end-to-end clinical trial oversight and/or specific modules such as biosample operations and outsourced biomarker analysis management.
hVIVO coordinates collection, storage and shipping from investigator sites to laboratories, reconciles logistics records and manages deviations while maintaining GCP/regulatory alignment.
Project managers set up and monitor external biomarker measurements, oversee validation and reporting deliverables, manage issues, and ensure appropriate transfer and archiving of results.
Yes—hVIVO can coordinate trial document preparation and review, support clinical trial application activities, and develop trial-specific plans such as monitoring and TMF plans.
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