Storage solutions for clinical trials involve many services ranging from Controlled Drug Handling (CII – CV), DEA Vault, Safe and Cage, Temperatures: Controlled Room, Refrigerated and Frozen, Global Distribution of Controlled Drugs, Import of Controlled Drugs, Returns and Destruction. Controlled drugs always make the clinical supply chain more complex.
In addition to the design and assembly of kits, CRO’s offers: Implementation of a kit strategy specific to the protocol properties, including sending kits per patient or per visit, Design and implementation of documentation, including laboratory manuals, laminated sheets, requisition forms, resupply forms, labels and logistics documents, Creation of shipping kits containing preprinted air transport letters and shipping documents
In light of the constant increase in the volume of biomedical samples collected during clinical trials, CRO’s now offers logistics strategy to optimize both the costs and the required quality of the necessary services.
Depending on the properties of the trial, CRO‘s may select and coordinate one or more transport providers for the same trial (integrated and specialist delivery services).
Biomedical sample storage services range from short- and long-term storage of the biomedical samples collected during a clinical trial to the management of a client's biorepository. Biorepository services include storage infrastructure, flow management, and location and data information management. At a variety of temperatures Ambient (15-25°C) and at ranging from 2-8? to – 190°C (liquid nitrogen – dry phase)
Sample storage services vary from 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.
Going global in a clinical trial context has its own sets of issues and challenges when it comes to sample collection for future clinical research. These challenges include managing the logistics of sample procurement, storage and sample lifecycle while taking into consideration ethical issues relating to the protection of patient confidentiality within the framework of the institutional approval process. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) published guidance documents addressing efficacy, joint safety/efficacy (multidisciplinary), quality and safety. These guidance documents are the ICH’s attempt to harmonize standards between Europe, Japan and the USA.
Multiple accreditations like CAPA credited, CLIA laboratories, GLP arena capabilities, ISO Partnerships are used to differentiate b/w a major CRO handling clinical trials globally with the one working in a regional manner.
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