Advice on study designs (PK, PD, clinical and PASS)

A proper study design is crucial for the study to achieve its intended purpose and be of maximum value to the drug clinical development. DADA has internal and external experts with experience in designing clinical studies that comply with the study objectives and purpose. DADA is able to provide advice on studies for bioequivalence, as well as non-inferiority or superiority efficacy trials for both human and veterinary products. Our team can tackle diverse challenges such as efficacy of combination products with new chemical entities, bioequivalence of controlled release dosage forms in comparison to immediate release dosage forms and many other complicated scenarios.

Additionally, during the pre-marketing/development phase of a medicinal product, DADA Consultancy can assist in the development of a Post-Authorisation Safety study (PASS) and take a leading role in the PASS protocol preparation and conduct.