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

January 9, 2019

Peace for our time? Will medical device trials remain the same after a no-deal Brexit?

The UK Government, more precisely the MHRA, had a productive start of the new year 2019 with a new guidance for medical device trials in the UK in case there is a Brexit with no-deal (published on the 3rd January...

Starter
Regulatory
Pre Market
January 7, 2019

Factory CRO and Boston Biomedical Associates Announce Merger

The merger realizes the shared strategic goal of becoming the leading Global Medical Device and Medical Technology Focused CRO January 7, 2019 Bilthoven, Netherlands and Marlborough, United States — Factory-CRO Group, a leading global contract research organization (CRO) focused on...

Starter
Factory
Pre Market
September 6, 2018

Risk Based Monitoring – A state of the art approach for your clinical investigation

Factory CRO witnesses and is part of a new trend in the clinical investigation landscape: Risk Based Monitoring (RBM). In this novel approach, focus lies on specific risks related to your clinical investigation, thereby more efficiently using resources, which improves...

Starter
Regulatory
Pre Market
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Welmoed Gjaltema

I like the dynamics, everyday is different. One day you’ll be at the office, another day you’re on site meeting new, different people.

Meet the team