CRO selection and auditing

DADA can help to choose the most suitable CRO for clinical studies phase I, II, III and IV. 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 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.