We assist you in choosing the optimal development strategy and will identify passionate investigators, sites and analysts for ensuring quick and sophisticated trial execution. Our team has the know-how needed in conducting clinical trials, developing regulatory strategies and realizing projects within budget and on time. Additionally, we closely interact with KOLs for the strategic development of your Biosimilar. Furthermore, our clinical studies often integrate pharmacokinetic evaluations to confirm clinically relevant metabolic differences between the proposed Biosimilar and the reference product.
Key aspects and challenges of Phase III clinical trials depend on the characteristics of the Biosimilar. Thus we provide you with customized and flexible study designs and offer a full set of leveraging support both within our own services and with selected partners to manage your clinical trial for Biosimilar and exploring new market options.