From Proof of Concept to Clinical Evaluation
Preclinical Research and Development
LabAnswer has designed and implemented pre-clinical systems for some of the world’s largest organizations. We support the pre-clinical laboratory with data, system and application integration. Our team of consultants have the ability to architect, design, configure, develop, implement, deploy and support nearly any laboratory informatics application (custom, open source and Commercial off-the-shelf (COTS)) for the pre-clinical laboratory.
Preclinical research and development is a stage of research that must take place before testing on humans in clinical trials can begin. Data is collected on safety, feasibility and repeated testing. Testing can be done on drugs, gene therapy solutions, medical devices, etc. with each class needing different types of pre-clinical research. Rigorous investigations are conducted to determine favorable benefit/risk profiles.
Testing is done in compliance with Good Laboratory Practice (GLP) regulations, which define specific organizational structure and procedures that need to be implemented in order to perform and document the tests and associated results – this may become critical for an enterprise to substantiate scientific discovery to obtain, support and defend intellectual property and/or patent rights.