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Clinical Trials Management Solution

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The increasing need to show compliance to regulatory guidelines means that this is an important issue for many research organizations, pharmaceutical and biotechnology companies running clinical trials.

The management of a sample repository or biobank requires the registration of samples as collected and tracking of their location at all times including the recording of a chain-of-custody.  It may also include the allocation of studies to specific storage locations e.g. a particular freezer, the use of storage maps, the need for parent-child sample relationships, donor details with consent and ethical approval processing and much more.

Autoscribe Limited has implemented Matrix Tracker solutions for a wide range of customers including clinical research organizations and pharmaceutical companies. Important issues that customers cite when choosing a system that matches their requirements include:

•  Compliance with current and future regulatory requirements – 21 CFR Part 11, HTA guidelines, MHRA.
•  A convenient way of registering and accessioning samples within the system including the easy retrieval of documents such as patient consent forms
•  Easy log-in, log-out and relocation of samples within the repository or biobank
•  Storage location audits, full audit trail for samples and the ability to produce a chain-of-custody for every sample
•  Management of consumables used for sample collection
•  A future proofed system that can meet today’s requirements and can be configured or re-configured to meet future requirements.