A CRO Built for Innovation in
Medical Devices, Drugs, and Diagnostics.

Proxima combines technology, therapeutic experience and a unique way of managing work based on principles of agile to de-risk your biotech or MedTech program, increase your chance of regulatory clearance and be more capital efficient

About Proxima.

Our team of Clinical, Regulatory, and Quality experts have led Proxima to the forefront of the healthcare industry. We continuously meet milestones, stay ahead of schedule, and ensure our clients overcome industry hurdles.
Regulatory
Engage with experts that understand today’s technology
Go to Regulatory
Clinical
Agile processes, combined with leading experts & technology.
Go to Clinical
Quality Management
Multiple ways to de-risk your platform
Go to quality

Case Studies

Loved by Innovators
See why organizations work with Proxima.

Our Services

A full integrated solution for life science companies.
Consulting, Clinical, Technology Solutions
Our clients rely on our experience and track record to develop a strategy that considers market advantage and investor milestones to succeed.
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Acronym assurance
CDER: Q-sub, IDE, 510(k), PMA, De Novo, BDD, HDE, CE Mark
CDRH: IND, NDA, BLA, 505(b2), RMAT
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If you are just getting started with drafting your first SOPs, installing an eQMS, facing an audit, or need to audit a manufacturer we have you covered.
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When it comes to clinical trials, trust is essential. Our clinical solutions are designed to fit your needs at the speed you deserve.
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Through our partnerships with data aggregators we enable your commercial teams with access to world-class institutions obtaining EMR, Labs, Claims, Remits, Charge Master and Specialty Rx.
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300
+
Clients
5,000
+
Patients Enrolled
35
+
Therapeutic & Industry Segments

Recent News

Proxima CRO’s Isabella Schmitt Named Finalist in 19th Annual Stevie® Awards for Women in Business
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FREQUENTLY ASKED QUESTIONS

What happens when the intended use of the proposed device is different from that of which appears on the labeling?
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TOOLS &TEMPLATES

Intro to PMA
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