Fernando Geijo and Xavier Ruiz, manager of QA for R&D and QRD auditor, respectively, at Azbil Telstar discuss the importance of adopting good practices in clinical research.
Research
In 25 years of professional life in the field of quality in clinical research, the changes in this area have occurred mainly due to two factors: Regulatory changes and scientific advances; but a concern for costs always underlies these changes, increased in recent years by economic crises arising from international situations.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.1