âClinical Research is a branch of medical science which focuses on the testing of the efficacy, safety and effectiveness of new drugs, medical devices and biological prior to approval for public use. The high cost of conducting clinical trial in the West, slow recruitment and retention of study subjects have made sponsors to relocate clinical trial to the emerging markets. The approval of new, efficacious and safe drugs for human consumption is premised on the generation of reliable and accurate laboratory data generated at both the pre-clinical and clinical phases of drug development using the good laboratory practice, good clinical laboratory practice and good clinical practice regulations. In most emerging markets, the quality of data generated from the laboratories has been questioned and these have been blamed on the poor understanding and implementation of the various GxPs regulations. The understanding of the entire quality management system in laboratory operations is very critical for the generation of reliable laboratory data which directly helps in the development and approval of effective treatment; with effect to reduce the impact of current disease burdens in the developing countriesâ Improving clinical research data in Africa: The understanding and implementation of laboratory quality management systems (LQMS), Augustine A. Onyeaghala.
Last date updated on June, 2014