We take pride in helping small, highly innovative device companies manage the development process just as effectively as the global giants do. It’s what we call an integrated approach—we think about everything, not just the logistics of running a clinical trial.
Many of our people come from sponsor companies, so they know what to ask up front. What indication provides the best return on investment? What claims make sense? How can you ensure that your device will qualify for separate reimbursement? What kind of pricing should you plan on?
There’s a lot to think about, and we focus all aspects of the development process on the single goal of turning your medical advance into a successful brand. For example:
- Upfront consultation and planning, including regulatory, health economics and reimbursement strategies.
- End-to-end clinical trial support, from trial set-up and operations to regulatory submissions.
- Rapid identification and assessment of potential risks during clinical trials.
- Up-to-date intelligence on changing EU/FDA regulations.
- Post-marketing surveillance and registry support.
- Global safety services.
You’ll find us not only capable and reliable, but also easy to work with. In a 2013 survey, Premier Research ranked first in customer satisfaction among all CROs, large and small, worldwide.
We’ve dealt with it all. And we’re eager to do it for you, from 10-patient feasibility studies to 10,000-patient post-marketing trials.