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

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
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
February 13, 2019

VIDEO: Factory CRO Group

Medical device company looking to partner with a global CRO but do not want a generic approach to your clinical trial? At Factory-CRO Group we are focused, efficient and flexible and pride ourselves in creating a custom plan for each...

Starter
Factory
Pre Market
12
Apr
Westkanaaldijk 7, 3542 DA Utrecht, Netherlands

Technical Innovations in Medicine (TiiM) Congres

Vrijwel nergens gaan de technologische ontwikkelingen zo snel als in de gezondheidszorg. Baanbrekende mogelijkheden schieten de grond uit, waardoor de zorg van morgen er compleet anders uit zal zien. Deze ontwikkelingen gaan gepaard met grote uitdagingen. Hoe grijp je de...

Meetings & Seminars
13
May
Rue du Fossé aux Loups 47, Brussels, Belgium

RAPS Regulatory Affairs Conference Europe 2019

RAPS Regulatory Conference – Europe 2019 is the inaugural conference designed by European regulatory affairs professionals for European regulatory professionals. It’s where the regulatory community will gather to discuss the most pressing regulatory topics, share experiences and network with other...

Meetings & Seminars
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Niels van Tienen

At Factory we have short communication lines, making communication fast, effective and efficient.

Meet the team