CRO selection and auditing

Choosing the appropriate Contract Research Organisation (CRO) for the conduct of your clinical study is vital during your clinical development. DADA can help you choose the most suitable CRO for clinical studies phase I, II, III and IV. It is also important to manage the clinical study appropriately, as the sponsor is ultimately responsible for the appropriate conduct of the clinical study. DADA can manage and monitor a complete clinical studies project. This means that DADA checks the study protocol before the start of the project, a representative from DADA is visiting clinical trial site(s) and DADA checks the final study report. DADA is most experienced in management of bioequivalence and bioavailability studies for human and for veterinary generic products.

In line with Good Clinical Practice, when performing clinical trials, it is the responsibility of the study sponsor to audit the clinical research organisation that is performing the trial. DADA can perform such an audit on behalf of the sponsor and has experienced auditors available to audit individual trials and clinical trial sites. On behalf of the study sponsor DADA can conduct GLP/GCP audits of CRO in line with current regulations, either as vendor audits prior to CRO selection and study start, or study specific audits during or following the study conduct.