When a Principal Investigator at a top-tier research university secured Department of Defense funding for two ambitious multi-site clinical trials on early treatment for traumatic brain injury, they turned to us to navigate the FDA’s regulatory landscape and ensure smooth trial execution.
Our role began with securing IND approvals for both trials. We worked closely with the FDA, drafting study protocols, submitting pre-IND questions, facilitating productive meetings, and compiling complete IND packages to meet rigorous standards.
Once the regulatory foundation was in place, we moved seamlessly into operational support. We qualified and initiated clinical trial sites, ensuring readiness across locations. Today, we continue to oversee site monitoring and play a key role in reviewing trial data as it comes in.
With our comprehensive expertise and proactive support, the trials are advancing toward answers that could change the future of traumatic brain injury care.
