Full Service 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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REGULATORY SERVICES

CE marking and FDA submissions

We are well acquainted with CE-marking studies and FDA regulations and can assure that your study can be designed and controlled to meet the demands of Notified Bodies and FDA.

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CLINICAL TRIAL SERVICES

  • Pre-study & initiation visits
  • Monitoring visits Source
  • Document Verification
  • Close out visits
  • Trial document handling
  • Reporting of safety information
  • Administrative tasks
  • Data Management
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REIMBURSEMENT SERVICES

Factory-Reimbursement for Medical Devices is here to help you navigate through your reimbursement problems and offers a tailor-made solution for all levels of reimbursement issues.

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Your Foreign Clinical Data: Does FDA Love It? Or does…

24 Nov 2015

We've been telling our clients for a while that their medical device studies outside of USA ('foreign') can very well be…

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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