Managing samples is a complex process. Clinical samples are typically collected in various locations before being transported, stored, processed, and analyzed by numerous vendors. There are some downsides to this fragmented approach. Some of the issues include spiraling storage costs, difficulties with data management, poor custody records, and slow transfer times. Here is a look at 10 drivers for outsourcing management of clinical samples.
1. Centralization
Long-term storage of both active and prospective clinical trial samples, regulatory samples, or legacy samples can be centralized. A biorepository vendor is capable of handling many varieties of sample types including:
· Proteins
· Cells
· Viruses
· Bacteria
· Animal specimens
· Tissue specimens
Biorepositories provide multiple storage conditions for different types of specimens. This centralized storage approach has benefits including easy identification of sample location, minimizing delays in sample handling, and simplifying vendor management.
2. Improving Speed
Oftentimes, biopharmaceutical companies move clinical trial samples to long-term biorepositories after the completion of a clinical trial. Samples may be stored at a variety of specialty laboratories, or at external biorepositories. But if the company has to retrieve the samples quickly, it can take weeks. A delay in retrieval can impact the outcome of a study in a major way. For this reason, it’s crucial to identify a partner who can offer timely sample retrieval.
3. Reducing Costs
Sample storage costs are calculated as part of a clinical trial budget. Unfortunately, once the study has ended, sample storage continues to be charged to the budget instead of clients. This makes it easy for a client to miss associated invoices and expenses. Outsourcing sample storage allows total access to samples and provides expense visibility which greatly reduces the costs.
4. Quality Assurance
Identifying a quality management system is crucial. They should meet the stringent diagnostic sample and GxP requirements. Integrated lifecycle management platforms manage vendor relationships and utilizes standardized sample handling processes. This ensures sample quality and integrity.
5. Mitigating Risks
Outsourcing protects sample and data assets by carefully monitoring and secure temperature-controlled facilities. Repositories should feature numerous redundancies, enduring business continuity, and pro-active risk management systems.
6. Logistics
The keys to successful logistics include storage experience, shipping, and tracking to ensure sample integrity, and proven risk mitigation strategies to keep irreplaceable assets secure. Also crucial for sample management are the maintenance of chain of condition, chain of custody, and chain of identity.
7. Flexibility
Engage with experts who provide flexible enhanced storage solutions. They should provide efficiency, integrations, and should be tailored to fit specific needs. Biorepositories can help customize clinical sample storage requirements by offering onsite, offsite, virtual, and hybrid storage solutions.
Final thoughts on Outsourcing Sample Storage
Good storage practices are essential to the integrity of every study. By outsourcing sample storage to reliable sources, it ensures the study’s smooth progress from beginning to end. Sample retrieval processes should not be complex or time-consuming as researchers need access to samples in a timely fashion. Outsourcing can provide the flexibility, logistics, and speed needed for successful research projects.
Resources
https://www.who.int/ihr/training/laboratory_quality/5_b_content_sample_mgmt.pdf
https://www.news-medical.net/whitepaper/20210617/What-is-sample-management.aspx
https://www.precisionformedicine.com/clinical-trial-services/clinical-sample-management/
https://www.titian.co.uk/en-us/the-essential-guide-to-managing-laboratory-samples-web
