Full Service Medical Device CRO

Factory CRO offers the top services for consultancy, regulatory,
and clinical trial services as well as data management and
statistics.

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Global Coverage

We are counted on for swift and reliable clinical medical
device/IVD services by companies and clients from every
corner of the globe.

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Questions?

We look forward to answering your questions and
helping you with the development of your device.

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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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DATA MANAGEMENT SERVICES

Our team of Data Managers will make sure your data will be well-structured, clean, consistent and in perfect shape to support the claims in your Clinical Study Report.

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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...

Starter
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...

Starter
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
8
Aug
ICC Sydney, Darling Drive, Sydney NSW, Australia

2019 ARCS Annual conference

For over 35 years, ARCS Australia has been bringing together a vibrant and diverse community of professionals working in academia, government, biotech and pharmaceutical companies, hospitals and healthcare settings and other organisations to showcase and support the development and regulation...

Meetings & Seminars
2
Oct
Clayton Hotel Burlington Road, Leeson Street Upper, Dublin, Ireland

2019 TOPRA Annual Symposium

The regulation of medical devices is continually changing as more innovative technologies and drug-device combinations are being developed. Anyone involved in medical devices and in vitro diagnostics needs to keep up to date with both the new EU regulations and...

Meetings & Seminars
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Richard Veerman

Factory has created a working environment in which knowledge and experience are shared to accomplish goals and complete projects as a team.

Meet the team