Biobanking for clinical trials: Beyond storage
This paid-for advertorial by Sampled appeared in DDW Volume 27 – Issue 3, Summer 2026.
Biological samples are critical across the clinical trial lifecycle, providing the raw material for understanding disease mechanisms, tracking biomarker dynamics, and evaluating both short and long‑term clinical outcomes. Biobanking supports this lifecycle at every stage by providing secure sample collection, storage, and processing, while also safeguarding the physical samples and their associated data to maintain traceability and ensure availability for reanalysis and longitudinal studies.
As clinical trials expand across multiple geographic sites and sample analysis becomes increasingly technologically demanding, the need for biobanks that fulfill a more integrated role is urgently needed.
Biobanks are the foundation of clinical trial success
It can be tempting to regard a biobank’s role in clinical trial sample logistics as a static function that merely requires sufficient capacity in an appropriate storage system and a reliable power supply. In best practice, however, biobanking serves as a dynamic network of technical capabilities spanning collection, processing, and shipment across physical and digital environments. When a biobank provides end-to-end support for clinical trial sample logistics, it helps preserve sample integrity and traceability, reduce risk, and enable more informed decision-making.
Designing sample collection for quality and integrity
Biobanks help to establish standardised, compliant sample collection protocols for clinical trials, providing kits customised to each sample type and its storage needs. These kits are critical for protecting sample quality in transit and ensuring specimens remain suitable for use throughout the trial and in subsequent studies. Effective collection requires kits to be prepared well in advance and co-designed with the clinical teams who will collect and oversee the early stages of sample logistics.
Processing that protects downstream data
When samples arrive at a biobank, they are first registered and assigned a unique barcode that ensures traceability and links each specimen to crucial clinical data such as disease status, treatment history, and pre-analytical factors. Biobanks must support the processing needs of diverse sample types, including blood, saliva, and tissue, as well as the extraction of analytes at scale. Automated processing capabilities help to reduce sources of pre-analytical variation, improving downstream assay performance and data quality across large trial cohorts.
Linking analytical workflows to trial success and patient outcomes
Samples generated during clinical trials are crucial for evaluating the investigational therapy, guiding the development of future treatments, and informing treatment decisions. In this context, the role of the biobank extends far beyond logistics. By combining well-preserved biological samples with rich clinical metadata, biobanks make it possible to directly and reliably link multiomic data to real-world clinical outcomes.
These outputs are only meaningful if samples are collected, preserved, and annotated in a consistent manner, and are readily available for analysis. For example, a study reported in Cell Reports Medicine (1) applied multiomic analysis to pretreatment biopsies from breast cancer patients enrolled in an immunotherapy trial. By profiling immune cell populations in this way, the researchers identified specific immune signatures associated with different therapeutic responses, helping to predict pathological complete response and enabling more precise selection of patients for whom immunotherapy would be beneficial.
The FDA recognises drug‐induced kidney injury biomarkers (2) that enable earlier detection of toxicities in clinical trials. Biobanks make routine use of these biomarkers possible by ensuring urine samples are consistently collected, correctly stored, richly annotated, and made available for timely analysis.
The compliance backbone of clinical trials
Biobanks help ensure that clinical trials, associated testing, and sample stewardship remain fully aligned with applicable regulatory frameworks. By operating under these standards, they help to confirm that equipment is validated, SOPs are followed, and staff are appropriately qualified and trained, with any deviations formally documented and reported.
As an integrated analytical laboratory and biorepository, Sampled provides end‑to‑end traceability of samples across the clinical trial lifecycle. By aligning with ISBER best practices and holding biorepository CAP-accreditation, and FDA licensure for the storage and distribution of certain human tissues, Sampled maintains robust, auditable control over all samples it handles. This enables reliable availability of specimens for longitudinal and follow‑up studies and helps ensure that trials, and their supporting digital and physical infrastructure, remain audit‑ready and compliant. In this way, Sampled helps to preserve the integrity of clinical work and enable the continued generation of evidence that drives the future of precision medicine and patient care.
References:
1: Campbell M, Wolf D, Yau C et al. Multi-platform biomarkers of response to an immune checkpoint inhibitor in the neoadjuvant I-SPY 2 trial for early-stage breast cancer, Cell Reports Medicine, 2024; 5
2: Zabka, T.S., Lawton, M., Chu, T., Friedman, G.S., Peron, K., Sultana, S.R., Glaab, W.E. and King, N.M.P. (2026), Biomarkers of Drug-Induced Kidney Injury: Use in Clinical Trials and Recent Examples of Impact on Drug Development. Clin Pharmacol Ther, 119: 608-617.
From DDW Volume 27 – Issue 3, Summer 2026 – Read the digital issue here