Integrity of data and protection of subjects
As defined in ICH 5.19.1, the purpose of clinical audits is to evaluate the trial conduct and compliance with the protocol, SOPs, GCP and the applicable regulatory requirements.
IT'sQA auditors are qualified and experienced in conducting audits of all systems, processes and studies in clinical research - including the interfaces with GLP and GMP and the use of computer systems.
We can help you develop and deliver a complete audit program for clinical trials or simply help with particular aspects of GCP audits including investigator sites, phase I units, live phase audits, qualification audits, database and statistics audits, clinical report audits, laboratories, computer systems, CRO audits amongst others.