Translating Science to Medicine info@celerion.com | www.celerion.com © 2018 Celerion Case Study | Drug Development & Regulatory Affairs BENEFITS n Leveraged existing nonclinical and Phase I safety and PK data to allow an initial proof-of-concept study as the IND-opening clinical trial n Obtained removal of the partial clinical hold and effective FDA input into proof of concept study design allowing the client to meet all critical milestones n Completion of the multi-site, proof-of-concept trial on time , with the positive results supportive of the new target indication n Quality ICH-consistent Clinical Study Report prepared on time NEED n Asian biotechnology company with a Central Nervous System (CNS) compound originally developed to treat a neurologica

Join for free to read