When it comes to thought leadership in data services, there are few companies that can match Brightech. For many of our clients, our most value work is our expert study design from our consultant team and company leadership. With an efficient study design, we can get you to submission with confidence knowing you have the most effective approach.
The services will be provided by our Innovative Trial Design Group comprised of experts and KOLs from industry and academia, as well as an experienced statistical programming team Brightech knows FDA regulations and the proper statistical approach, to help sponsors design efficient studies; through regulatory to the final submission package.
Our expertise with innovative study design (group sequential, adaptive and dynamic adaptive design), sample size estimation in design stage and re-estimation in interim stage and interim analysis allows us to deliver the most efficient path from study design to database lock.