Clinical Trials Management Solution
Product News Dec 22, 2010
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.