Clinical Sample Management
Clinical Trial Solutions serving Central Laboratories, Clinical Research Sites, Sponsors, and Contract Research Organizations
Clinical sample management requires strict record keeping and reporting to meet compliance requirements, full chain of custody, well-established operational flows, oversight, and reporting for every stage of the sample’s shipping, handling, and storage onsite and offsite. Cryoport Systems’ BioServices solutions focus on high-quality, integrated services encompassing clinical sample management activities including patient sample processing, testing, storage, and logistics as well as sample kit production, clinical documentation writing, and real-time monitoring. In addition to storing your materials in ultra-secure, GMP, GCP, and GCLP standard infrastructures, we provide the centralized administration of your logistics flow. Our clinical sample management capabilities integrate with our broader platform of supply chain services to create complete support throughout all phases of clinical trials. We assist in managing service providers and all stakeholders (trial centers, carriers, laboratories, and monitoring CROs) to ensure that their activities are fully aligned with the demands of your clinical trials.
Cryoport Systems offers sample preparation and analysis, analytical services, customized clinical sample kits, lab manuals and forms, secure storage, logistics, complete traceability, and availability of collected samples.
We specialize in providing:
- Innovative material documentation, processes, and systems to simplify the work for clinical sites, monitoring CROs, and sponsors as well as bioanalysis laboratories and carriers
- Remote-accessible business intelligence tools connected to our Clinical Trial Management System (CTMS), Laboratory Information Management System (LIMS), and Enterprise Resource Planning (ERP) for real-time monitoring, review of indicators, and data report generation
- Project Management with a dedicated Program Manager for high-performance tracking systems and coordination of activities from the pre-sales phase to project close-out
- Comprehensive logistics management and traceability of critical samples from site to site, including the specific deadline requirements which can be managed with the assistance of a Program Manager
- Bespoke sample collection kits specifically designed, manufactured, and distributed to ensure the quality and traceability of your biological samples
- Laboratory manuals, sample collection forms, material supply forms, kit instruction leaflets, and color-coded label sheets to create dedicated documentation for clinical sites
- Sample import/export authorization obtainment and material customs clearance management
- Sample preparation and analysis using validated processes to ensure impeccable control over analytical variables and robust results
Certifications, Authorizations, and Applied Standards:
- ISO 9001:2015 and ISO 20387 certification accreditations
- Application of good pharmaceutical practices: GMP, GCP, and GCLP
- Authorizations by ANSM: Biological Drug and ATMP (investigational & commercial products) import, storage, secondary packaging, certification, and distribution
- Raw Material for Pharmaceutical Use (RMPU): import, storage, labelling, and freezing
- Human tissues and cells: storage (tissues and cells covered by current authorization: hematopoietic bone marrow, PBSC, cord blood, T Cell and musculoskeletal bone)
We can accommodate additional authorizations in accordance with ANSM (The French National Agency for Medicines and Health Products Safety) within 60 to 120 days’ notice depending on the type of request.