Clinical Trial Sample Management
Biomarker-based trials need effective sample management
Targeted and personalized studies with well-defined patient segmentation biomarkers are becoming the norm in clinical trials. This increased interest in molecular biomarker studies necessitates a rigor and sophistication in sample management within the clinical trial context that is often not supported either by traditional clinical trial management software (CTMS), or biobanking systems. Typical organizations may have hundreds of trials, thousands of trial sites and millions of samples and often the collection, transportation, storage, and processing of samples is being outsourced more and more since clinical trial sponsors may have limited intent and/or capacity to directly handle these activities. However, in this complex research ecosystem, the sponsor is still legally accountable for detailing the proper status, usage, custody, and destruction records of the collected samples. Furthermore, such samples represent an important knowledge-base of biomarker data for the sponsoring organization so there is an increasing need to manage these “future use” specimens and their associated consents.
Distributed trials pose challenges
Clinical trials today take place in a complex research ecosystem of sponsors, vendors, CROs and collaborators Each of these multiple internal and external parties carry out different roles and actions in a distributed and asynchronous fashion. Timely research and sample release decisions are often difficult due to a lack of visibility in sample-related information and the surrounding meta-data, especially consent. The following challenges are typical in a clinical trial sample setting.
- Exactly where are the samples right now?
- When were they received by the CRO, and what was done with them, where is the data?
- How can reconcile sample inventories and subject consents from multiple sites and partners (e.g. expected vs. reported)?
- We want to perform an additional analysis – what is the consent status of this subject
With little or no sample management infrastructure for inter-organizational operations, and no easy mechanism for logistics, consent tracking, queries or reports, clinical trial sponsors face multiple operational burdens to manage the variations in biospecimen types, collection sites, permissions, and data formats from different business partners. As a result, many sponsors are struggling to manage their clinical trial sample inventory, ensure compliance as well as maximize the scientific value of the annotated biospecimens.
Next Generation sample management for clinical trials
Effective operational management of millions of clinical trial specimens linked to rich clinical, molecular, and bioassay annotations in a distributed environment of various partners, while maintaining compliance can be overcome by adopting BioFortis’ Next Generation Biobanking approach. Our Next Generation Biobanking Platform, based on Labmatrix offers the critical informatics infrastructure to;
- effectively manage millions of trial specimens in a “virtual biobank” across the distributed vendor-partner ecosystem, while maintaning compliance.
- integrate in multiple data sources for annotations.
- provide powerful tools for exploring this rich biomarker knowledge-base.
Why choose Labmatrix for your clinical trial sample management?
Enhanced security and compliance - Fine-grained access controls and security that extend across the biospecimen to its data and ensure that colaborators, internal and external trial partners have the access they need, while maintaining compliance.
Support for a distributed research environment - Providing the critical informatics infrastructure to track patient consent status, manage samples and data among all clinical trial collaborators in a secure, validated software environment, the virtual biobank.
Collection and harmonization of biospecimens with clinical and molecular data - support for data integration and harmonization with specialized informatics systems (such as EMR, CTMS, EDC, and LIMS) allows tight linkage of the biospecimen with clinical and molecular data across the distributed network of trial partners, independent of physical location of data or sample.
Day-to-day operational management of clinical trial samples - provides a unified view of samples from current and past trials. Samples can be viewed, tracked and consent verified for both in-life and future use anywhere in a global network of partners.
Generation of scientific insights - puts powerful tools for data exploration, reporting and ad hoc query in the hands of researchers so that they can mine the richly annotated biospecimens to drive biomarker and translational research studies.