Changing regulatory landscape is a challenge to Medical device and Diagnostics companies.
CBCC-Vibgyor is one of the few CROs in India with in depth experience in Medical device studies. Our experience includes premarket, post-approval, and post-market device trial management, including regulatory development, planning and submission support. We conduct human trials in all phases, from single-center feasibility trials to large multi-center, randomized controlled trials, with a full service offering.
Our thorough understanding of device therapies for various therapeutic applications helps us in ensuring compliance with the protocol and regulations. It also helps in identifying risks of a trial and plan mitigation strategy in advance, which facilitates seamless execution.
Our unmatched operational execution, emphasis on quality through our quality assurance program including ISO 9001:2008 certification have been key factors to help us win confidence of top four multinational device companies, whom we have supported in clinical development.
The repeat business that we get from our sponsors is a testimony of happy clients.
Our therapeutic expertise includes:
- Cardiology, cardiac surgery