Biosimilar/Innovative Biologic trials require a customized approach based on the therapeutic indication and study specific goals. We work with our clients to develop an effective plan and execution strategy for Biosimilar and Biologics clinical trials that includes subject recruitment, regulatory, clinical safety monitoring, specialized pharmacy expertise, and bioanalytical support while ensuring subject safety throughout the entire trial
We have taken part in several successful conduction of biosimilars, Biotech drug and Orphan disease clinical trials from Phase I-III with successful marketing authorizations in Europe, and other regions, registration trials on both healthy subjects and patients, including the following:
Clinical therapeutic trials
Ianalumab and Lanadelumab
Clinical trials from Phase I-III of Monoclonal antibodies/protein derived molecules, such as: Warm Autoimmune Hemolytic Anemia (WAIHA), Hereditary Angioedema (HAE) and Rheumatoid Arthritis.