Advise on study designs (PK, PD, clinical, PASS)
DADA has internal and external experts with experience in designing clinical studies to comply with the study objectives. DADA is capable 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 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.