Quality Management has been a part of every industry over last many decades. The concept has evolved and refined over the years and has also changed the outlook of the industry. Hence, it is no surprise to consider it of prime importance in the clinical research arena.
Since this industry puts in lots of efforts in shortening the length of time that it takes to develop a molecule which is safe and efficacious to be used in humans, to value such a complex procedure we need a thorough understanding of the subject. The strict timelines to bring the product to light and to capture the essence of the market has started a fierce competition within the pharma sector. The finished products after all need to be valid and should be competent. To achieve this target the research arena is well regulated with guidelines and laws.
Quality in clinical research is to be kept as a prime motive with our focus on guidelines and laws and respecting them with a strict implementation. Documenting everything is the thumb rule and this should be in-line with guidelines, regulations and the Standard Operating Procedures. The department of Quality Assurance has gained a lot of importance in the last decade because of the cited reason.
An effective Quality Management system for clinical research helps to ensure that research is planned, conducted, analyzed, reported and managed in compliance with guidelines, regulations, SOPs and is also protecting ethical rights of a subject. Quality at every step while conducting research can only give us quality results.