Biological Sample Management requires expert logistical services. This is exactly what CSM’s highly-trained staff offers you. Our team efficiently and consistently provides flexible, integrated, sample management solutions for your clinical trial(s) that reduce the overall costs and save you time. We can guarantee that the integrity and quality of your biological samples are always a top priority of ours. CSM services are designed to meet the specific needs of your clinical study.
This blog is a part of the series, "CSM's Guide to Biological Sample Management".
Sample Collection Kits
CSM’s biological sample management services offer design and assembly of sample collection kits. Our customizable design includes a full documentation process for lab manuals, labels, and shipping documents. We also provide IATA-compliant ambient and frozen shipping boxes along with combined and cooled shippers.
Our sample collection kit building methods are as follows:
- Implementation of a kit strategy specific to the protocol properties, including sending kits per patient or per visit
- Design of the biological sample collection kits and labels (including the identification of subjects and tubes) and associated documents (including the related requisition form)
- Design and implementation of documentation, including laboratory manuals, laminated sheets, requisition forms, resupply forms, labels and logistics documents
- Creation of shipping kits for the biological samples containing pre-printed air transport letters and shipping documents
CSM’s biological sample and pharma logistics provide services to our clients to optimize both the costs and also to maintain the required quality of the necessary bio services and supplies. CSM’s method involves regulatory compliance and strategic collaboration to ensure you’re provided with the best sample logistics solutions specific to your clinical trial’s needs. Generally, this includes clear instructions, complete traceability of all samples, and aliquots in a way that guarantees the correct identification of your biospecimens on an individual basis.
We provide a globalized list of all the aliquots generated on different sites during your clinical trial and the consolidation and verification of the data associated with that list of aliquots. We also manage the dispatch of samples to their predetermined locations (such as analytical labs and storage facilities). Our management process follows all GCLP requirements.
Our Track Record:
- Each month we receive over 100 sample shipments from clinical sites and central laboratories worldwide
- Over 450,000 biological sampling kits assembled since 2015, with only 0.002% incidents/deviations
- Over 1,800,000 samples stored
- Over 750 clinical trials involving kits shipped to 86 countries worldwide since 2005
- 150 freezers at dedicated BSM sites in the US and EU
Biorepository services include storage infrastructure, flow management, and location and management of sample demographic data.
Biorepository Services includes the following:
- Short and long-term biological sample storage
- Management of a client’s entire biorepository
- One database for our centralized global studies services, which creates an access tool for monitoring the import of demographics. This also allows you to view specific samples and their storage facilities.
- Storing biological samples a variety of temperatures including cold chain storage requirements
- Of blood, plasma, urine, feces, tissues, serum, biopsies, cell cultures, paraffin blocks, DNA and other substances
- In all types of tubes, individually, by cryo-box or in bulk
Want to skip the rest? Call for a consultation to speak to an expert in the field and move your biorepository samples for free!
CSM Sample Data System
The CSM Sample Data System is a proprietary information tool used for storing and managing your biological samples. It is 21 CFR Part 11 compliant. We can provide storage of human, or animal, biological samples to meet good (clinical) laboratory practice (GCLP and GLP). We provide around 150 freezers with approximately 1.8 million stored samples. Both Europe and U.S. locations combined have the capacity for over 350 freezers, including liquid nitrogen storage.
Storage capabilities are available at a variety of temperatures (including cold chain storage requirements):
- Ambient (15-25°C)
- – 20°C
- – 40°C
- – 80°C
- – 190°C Cryogenic (liquid nitrogen – vapor phase)
With the CSM Sample Data System, CSM will successfully manage the de-identification of biological samples, no matter what the project specifications are. The CSM Sample Data System follows a tried-and-tested sample de-identification module. The labeling and data procedures are fully secure in terms of personally identifiable information traceability. We regularly perform quality control and visual checks to ensure the correct label is removed/applied. The database allows the recording of de-identified sample data up to 19 fields. Additionally, this includes the creation of new codes and labels one by one, which means avoiding any risk of mislabeling samples. Our process also includes the removal of blinded data, which ensures that the packing list only contains data that can be shared with the lab.
CSM’s procedures for the sample de-identification process requires:
- The safest handling of the biological samples
- Adequate labeling materials and processes
- Integrating our strong IT system to manage the allocation of old and new identifiers
- blinding of data and keeping the original data behind the scenes
Our highly-trained, accomplished team is empowered to provide high levels of agility and state-of-the-art consultation services. Every step of the way, we provide consultation as a clear advantage to help our clients plan and execute all sizes and scopes of your biological sample management needs. Our customer-centric focus will make the management of your biological samples more efficient, thereby reducing the costs and ultimately improving outcomes. Our experienced and knowledgeable consultation representatives assist with sample logistics planning, which includes a free 20-minute BSM consultation.
CSM Europe received the biobanking authorization from the Belgian authorities allowing import, export and storage of human samples for research purposes, even outside the scope of clinical trials. As required by law, CSM has an MD check the consent templates provided by the owner of the samples, before sending them to a third party.
Our team of project managers is available at any time for updates or inquiries. We ensure that they are up to date and familiar with all aspects of your clinical trial because we see ourselves as an extension to your study. This is why your CSM team also includes a backup clinical support services project manager who can seamlessly take control of your project if the lead clinical trial project manager is unavailable.
Furthermore, for global clinical trials, CSM provides a project manager in one of our EU sites who will specifically work to globally assist and manage activities with the whole project management team.
While biospecimen management during clinical trials can sometimes be complicated and seem difficult or exhausting, there are plenty of ways to surmount these obstacles. CSM takes enormous pride in the sample management solutions we provide and takes the worry out of sample management.
Our highly-trained staff has competently served clients in academia, pharmaceuticals, biotechnology, and central laboratories. Additionally, we have assembled over 450,000 patient collection kits across 750-plus clinical studies. Experience all that CSM has to offer you and your clinical trial study needs, we are confident your endeavors will be better-accomplished with CSM at your side.
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