Global Coverage

With offices in the U.S., Europe and the Caribbean, Factory CRO is one of the world’s leading CROs specializing only in medical devices and IVDs.

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Full Service Medical Device CRO

Factory CRO offers comprehensive consultancy, regulatory and clinical trial solutions as well as data management, statistics and reimbursement services.

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Questions?

We look forward to answering your questions and helping you with the development of your medical device or IVD, and/or your reimbursement challenges.

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Regulatory Services

Our deep understanding of U.S. and European regulatory agencies ensures your study is designed to meet all pre- and post-market approval requirements. We can assist you with regulatory submissions and study progress reporting.

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Clinical Trial Services

Our clinical team has extensive experience and knowledge in the clinical trial field, including monitoring & source document verification, trial document handling, and site visits (pre-study, initiation & close out).

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Medical Writing Services

Factory’s expert team of medical writers can support you in various ways, including clinical study design, protocol development, clinical evaluation, reporting of study results, and Investigator’s Brochure writing.

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Reimbursement Services

Our reimbursement strategy support services are available from conception through product launch and beyond.

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Growing In North America

With Factory’s acquisition of MileStone Research Organization in San Diego — combined with our offices in Princeton, N.J.; Austin, Texas; Minneapolis and the San Francisco Bay area — we now offer a full range of clinical operations, regulatory, reimbursement and strategic development services in the U.S.

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Latest news, blogs and events

March 1, 2019

No-deal Brexit Scenario: What Will Happen With The Medical Device Industry?

With 30 March 2019 approaching, the possibility of a no-deal Brexit is still very likely. What happens if a no-deal Brexit occurs? At Factory-CRO we have been thinking a lot about that scenario. Below are six key areas to consider...

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Regulatory
Pre Market
May 8, 2019

Factory-CRO Group Bolsters Leadership Team, Solidifying Position as Leading Medical Device and Novel Technology CRO

May 08, 2019 17:00 AM Central European Time Bilthoven, Netherlands — Factory-CRO Group, a leading global contract research organization (CRO), is pleased to announce Sapna Hornyak as its new president and CEO and the appointment of Nick Thornton to chairman...

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Factory
Pre Market
February 22, 2019

As of TODAY you can collect clinical device data for your IDE or PMA outside of the USA

A year ago, the FDA published their final rule on the acceptability of medical-device clinical data collected outside of the USA (OUS) to support an IDE or device marketing application (1). Published in February 2018, the effective date of the...

Starter
Factory
Pre Market
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