Clinical trial samples are not replaceable. A blood draw taken from a participant at a precise time point in a phase II study, a set of nasal lavage samples from a human challenge cohort, a batch of PBMCs processed from carefully enrolled volunteers: these represent months of recruitment, regulatory preparation, and participant time. If something goes wrong with how those samples are managed, you cannot simply go back and collect them again.
Yet sample management failures are more common than many sponsors expect. Here is where things typically go wrong: and what a well-structured biobanking partner should have in place to prevent each one.
In multi-site trials, samples are often collected and processed locally before being shipped to a central laboratory or storage facility. When each site handles processing differently: different centrifugation speeds, inconsistent freeze-thaw timing, variable labelling practices: you end up with samples that cannot be reliably compared.
The solution is centralised processing. hVIVO's sample processing network and GCLP-certified laboratories bring sample handling under a single, validated workflow: receiving samples, logging and processing them to protocol, aliquoting, and placing them into controlled long-term storage, all within the same integrated facility.
Every transfer of a temperature-sensitive sample is a risk. Samples shipped between collection sites and storage providers can be exposed to unacceptable temperature excursions: during transit, during customs holds, or simply due to inadequate packaging. A single excursion can invalidate a sample for regulatory purposes, even if no physical degradation is visible.
Reducing the number of transfers reduces the risk. Combining storage with clinical trial kit production and logistics under one roof: as hVIVO does in Greenwich: means fewer handoffs, shorter transport legs, and tighter control over cold chain integrity from collection to archive.
For regulated clinical studies, the chain of custody is not an administrative nicety: it is a regulatory requirement. Auditors and sponsors need to be able to demonstrate exactly where each sample was at every point in its lifecycle, who handled it, under what conditions, and what happened to it. Gaps in this record can compromise data integrity and, in worst cases, invalidate study results.
hVIVO operates robust sample traceability across all storage and processing activity, with full chain-of-custody documentation available to support regulatory submission. Every sample intake, movement, aliquot, and retrieval is tracked and recorded: including single-vial requests dispatched at short notice.
Not every organisation that needs to store human biological samples holds its own Human Tissue Authority licence. This is particularly common among early-stage biotechs, academic spin-outs, and international sponsors running UK-based studies. Storing human tissue without appropriate HTA coverage is a regulatory breach. hVIVO holds a full HTA licence and can provide HTA Designated Individual (DI) coverage for study collections where your organisation does not hold its own. Read more about human biospecimen storage.
Freezer failures happen. Power outages happen. What distinguishes a competent storage provider from a dangerous one is whether they have invested in the infrastructure to handle those events without sample loss: redundant backup power, automated alarm systems, 24/7 monitoring, and documented 24/7 emergency response procedures.
hVIVO's cryostorage facility in Greenwich operates with backup power supply for uninterrupted sample security, continuous 24/7 temperature monitoring and response, and alarm systems configured to trigger immediate action. See the full list of storage capabilities and safeguards.
Samples that are stored in isolation from the laboratory that will eventually analyse them add unnecessary complexity. When storage and analysis sit in separate organisations, retrieval requests take longer, transfer documentation multiplies, and the risk of sample mix-up or degradation increases. hVIVO's storage capability is directly integrated with its PBMC processing and isolation, virology laboratory, immunology laboratory, and broader laboratory services: enabling end-to-end sample management under a single quality system.
The organisations that encounter the fewest sample management problems are typically those that treat biobanking as a strategic function rather than a logistics afterthought. Selecting an integrated provider: one that connects storage, processing, traceability, regulatory coverage, and downstream analysis: removes the handoff points where things go wrong.
hVIVO provides end-to-end biobanking and storage solutions from our Greenwich facility, processing over 85,000 samples per year and maintaining a biobank of more than 500,000 samples. Speak to our team about how we can support your study.