Medical Device & Diagnostics

These highly specialized trials require specialized understanding – backed by full lifecycle services – for every category of medical device, diagnostic, and companion diagnostic.

prcom_Asset 1ARROW

PREMIER VOICES

Far-reaching implications

The European Union’s new Medical Device Regulation and In Vitro Diagnostics Regulation mean big changes for the medical device industry. If there’s a common denominator among them, it can be summed up in one word: more.

PREMIER PERSPECTIVE

Not the same

While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct – and there are critical differences in the way the device trials are designed and executed.

Full lifecycle services

Building your breakthrough into a successful business

Whether you’re conducting a 10-patient feasibility study or a 10,000-patient post-marketing trial, we know the steps from scientific breakthrough to successful outcomes. Our experience spans just about every type of device, from advanced surgical instruments and meshes to combination products.

Many members of our medical device team come from manufacturers, so they know what questions to ask: What indication provides the best return on investment? What claims make sense? What about pricing, and ensuring that your device will qualify for separate reimbursement?

We understand the differences among categories of medical devices and diagnostics, and our regulatory team tracks the latest U.S. and European policy shifts and regulatory requirements.


Premier Thought Leadership

Joanne Emmett

Joanne Emmett came to Premier Research as Vice President, Global Clinical Operations, in 2011. Ms. Emmett’s past operational experience within large and small CROs brings to Premier Research a strong and diverse skill set focused on customer service. She held key positions at PRA International and AAIPharma, where she focused on building strong team performance and delivering services that more than met customers’ needs.

Therapeutic Focus

Therapeutic Focus

Therapeutic Focus

There’s no substitute for experience. And we have a lot of it. See what we’ve been busy doing for the past five years.

Related Capabilities

A great strategy is nothing without great execution. Look here for experience in clinical R&D, product development consulting, and technology applications that ensure data integrity, process efficiency, and timely analytics and reporting.

Clinical Research and Development

Clinical Research and Development

Product Development Consulting

Product Development Consulting

ePremier Technology Platform

ePremier Technology Platform

Check out our resource center

Our experts have developed an extensive library of white papers, case studies, blogposts, and other informative resources.

PREMIER INSIGHTS

PREMIER INSIGHTS

WHITE PAPERS

WHITE PAPERS

WEBINARS

WEBINARS

VIDEOS

VIDEOS

PODCASTS

PODCASTS

Connect with us

Ready to get started? So are we. Drop us a line to learn more about how we can help.