Good Clinical Practice (GCP) compliant
As a member of the Medicines and Healthcare products Regulatory Agency (MHRA) GLP monitoring programme, Alderley Analytical are also periodically inspected for Good Clinical Practice (GCP) compliance by the same body. This means that we can claim GCP compliance when supporting clinical studies.
We ensure that analysis of samples from clinical trials complies with GCP regulations and that they are conducted in accordance with the EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples.
GCP is an international quality standard that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.
The recommendations, rules and guidelines on how good clinical research should be performed, affect all aspects of clinical research including:
Monitoring and auditing of a study
Recording, analyses and reporting
GCP provides assurance that study data and the reported study results are credible and accurate, that the rights, safety, integrity and confidentiality of study subjects are protected and that the studies are conducted to a high standard.