Clinical

Your data is coming along, your team is growing, and your company culture is taking shape. As you become more organized and disciplined, you’re starting to attract attention. With your products moving through the stages and getting closer to regulatory approvals in the U.S. or Europe, you may realize the need to outsource some tasks. 

A growing pipeline and ongoing research in new therapies may mean it’s time for a Quality Management System (QMS) check to ensure your data is solid, participants are safe, and trials are reliable. Regulatory agencies look closely at these QMS systems when approving clinical trials to make sure they meet the right quality and compliance standards. This includes reviewing how you monitor and audit trial activities, catch any deviations from protocols, and take necessary corrective actions. 

We at BIOBOSTON Consultancy can help with preparing your IND and provide full support from the initial submission all the way to BLA/NDA approval. We review applications to assess the risks and benefits of your proposed trial, ensuring everything is in line with regulatory guidelines. Once approved, you can run the trial with confidence, knowing you’re following the proper protocol. 

If you’re focused on getting ready for inspections, we can guide you through that process too. Whatever your clinical needs, our team has the experience to be your trusted partner.