What is the best way to select indications and develop drugs for treatment of diseases in the rheumatology space? We provide:
Early phase development: We identify the optimal indications and define the critical non-clinical studies required for moving to first in man studies.
Clinical development planning: The crafting of clinical strategy will be aligned with the regulatory and commercial strategies for the overall development pathway. The clinical development plan begins with an understanding of the final product that will be delivered to patients.
Clinical trial design: Embarking on trials where suitable, accepted, validated outcome measures are not available is wasteful and costly. The availability of such outcome measures for specific indications are considered in evaluating the feasibility of clinical development. The appropriate population, inclusion and exclusion criteria, sample size considerations, stopping rules, and the questions to be answered by trials in the development pathway are rigorously addressed.
Advisory boards: We can identify appropriate advisors for your programs and products. These include members for Scientific and Clinical Advisory Boards, and Data Monitoring Committees.
Other services: These include risk management and epidemiology services, protocol design, assistance with informed consent forms, investigator’s brochures, and clinical components of regulatory documents, training of investigators and staff, and advice on setting up clinical and safety organizations, systems, and processes.