Clinical study reports
DADA has monitored more than 60 complete BA/BE projects and has evaluated over hundred BA/BE study reports. For over 30 years, our experts have reviewed many more clinical study reports prepared by CRO’s all over the world. Comments and recommendations given by DADA clinical and regulatory affairs experts have been found particularly helpful in case of “old” dossiers that required resubmission for regulatory review (e.g. for new applicants or additional countries).
DADA has substantial experience in writing full study reports of several types of clinical trials for both human and veterinary products; pharmacokinetic studies, bioequivalence studies, efficacy studies etc. We can write a study report from core study documents, as well as build on an already existing draft. All study reports written by DADA are based on and compliant to the ICH E3 guidance.