Biologics and Biosimilars Clinical Trial Services

This document is a guide outlining the comprehensive early-stage clinical drug development services provided by Altasciences, specifically focusing on biologics and biosimilars. It details the various types of studies conducted annually, including clinical, bioanalytical, data services, and pharmacokinetic comparisons. The guide emphasizes the company's extensive experience in conducting clinical pharmacology studies for biosimilar submissions, highlighting the ability to recruit up to 250 subjects per study. It describes the full-service clinical experience, including clinical monitoring, protocol development, data management, and biostatistics. Additionally, the document explains the study design process, which includes collaboration with regulatory consultants and specialized recruitment strategies. The bioanalytical expertise section outlines the capabilities in LC-MS/MS and Ligand Binding platforms, detailing the support provided for all stages of drug development and the advanced facilities available for conducting studies. Overall, the guide presents a thorough overview of the services offered to the global biopharmaceutical industry.