Install and validate a LIMS to support clinical studies and global sample inventory.
Scientists around the globe need the ability to work with diverse samples in order to determine drug efficacy and safety of potential drug treatments. The participation of internationally diverse populations in HIV clinical studies is critical. International participation is essential in testing how a vaccine may work on different clades (strains) of the virus. For example, the predominant HIV virus in Africa is different from the North American one. These clinical studies also examine secondary factors such as differences in genetic background, age, nutritional status, effects of other infections, and access to health care, which affect the development of vaccine for use around the world.
LabAnswer guided the design, implementation and validation of the LabWare Laboratory Information Management System (LIMS) to support international AIDS research. The system automated the transfer and tracking of samples from collection, repository, and assay testing. A central master specimen system was used for tracking samples across remote processing and testing sites. The local testing sites managed the detailed location of specimens down to the slot within a cryobox. Sample status was managed back into the central system until final destruction. Final analytical results were exported for further analysis and review. The implementation and validation efforts were closely coordinated ensuring that the requirements gathering, coding and testing of the development effort were conducted in a way to drive efficiencies in the validation effort. Validation made for a quality implementation and facilitated partnering with a Tier One pharmaceutical.
- Real time identification of sample description and location
- Collaborative test results with global access to results
- System validated to exceed applicable regulations
- Facilitate collaboration and support of tier one pharmaceuticals