Our Experience: Medical Device & Diagnostics

In order to underscore the growing importance of medical device and diagnostic development within Premier Research, we have renamed ourselves Premier Research Medical Device & Diagnostics.

We are expanding both our staff and the scope of our services to carry our customers—especially smaller startup companies—from early strategy development (What claims and indications should you target?) right through to regulatory approval, FDA Advisory Panel preparation and pricing and reimbursement strategies.

But it will be “business as usual” for our current device and diagnostic development customers. Whether you have a small 10 patient feasibility study or a 10,000 patient post marketing trial, we will continue to offer the specialized, hands-on experience and geographic reach you need to build your scientific advance into a successful brand.

Highly Relevant Experience+

There’s no such thing as a generic medical device specialist. It’s all about specifics. And we can staff your project with people who have worked on just about any type of device, from advanced surgical instruments and meshes to combination products. Click here to view our broad therapeutic area experience. 

We even have geographic area specialists, locally based in key regions, often native to the language and culture and always thoroughly familiar with the regulatory environment and patient population of their region.

Complete Life Cycle Support+

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. 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.

Clinical Support Tailored to Medical Devices+

With almost 20 years’ experience, all of it devoted 100% to medical device development, the clinical experts at Premier Research Medical Device & Diagnostics know how to plan ahead, avoid problems and resolve any that do arise before they can cause major delays.

Our full service support includes:

  • Strategic and tactical study design
  • Project management
  • Clinical monitoring
  • Study nurse and technical site support services
  • Medical Affairs and Strategic Consulting
  • Interactive randomization technologies
  • Electronic data capture
  • Data management
  • Biostatistics
  • Medical writing
  • Quality assurance
  • Regulatory affairs

Exactly how are device studies different? Click here to view our recent webinar, "Medical Device and Drug Research: Similarities and Differences."

Locations Worldwide, Where We Need to Be+

By “global” we don’t mean “big.” “Global” means we’re strategically located where our customers need us, in regions that ensure rapid access to patients and, often, lower operational costs.

Experienced senior management – all device specialists, many of whom learned the business at leading sponsor organizations – actively oversees every project. Local managers across the globe handle day-to-day responsibilities, working with staff members who speak the local languages and know the lay of the land in their respective territories. 

A network of regional offices provides biometrics, post-marketing, medical writing, safety and regulatory services as needed. In addition to the comprehensive study management services we offer, Premier Research also maintains a network of dedicated research centers.

Who We Are and What We Stand for—A Quick Checklist+
  • Dedicated, experienced and well-informed Medical Device team
  • Close to 20 years experience in multiple therapeutic areas
  • Specialists within the specialty, with expertise in just about every different kind of medical device 
  • Full service support across the Medical Device life cycle
  • Significant combination product experience
  • More than just trials—an emphasis on planning, tactics and strategy
  • Proactive project management with an emphasis on risk mitigation
  • ISO 9001 and 13485 certified
  • Customer service excellence 
  • Consistent delivery of conclusive trial result

We’re 130 people strong and growing, 100% dedicated to developing medical devices. We’ve dealt with it all. And we’re eager to do it for you.

Knowing what works, sharing what we know. It's what we do. Best.