Full Service CRO

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

Learn more

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.

Learn more

  • 1
  • 2

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.

READ MORE

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
READ MORE

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.

READ MORE

DEKRA audit 2016

04 May 2016

On May 3rth, 2016, Factory CRO was audited based upon the ISO13485:2003 and ISO9001:2008 audit criteria by the DEKRA. We…

Read more

Monitoring in investigator-initiated clinical trials

04 May 2016

A research to barriers that impede adherence to national monitoring guidelines In response to major incidences of fraud, data-manipulation and misconduct…

Read more

The medical device industry; a catalyst for regulatory innovations

19 Apr 2016

The regulators versus the medical device industry, who’s in the lead? In the perpetual developing environment of medical devices, international…

Read more

Patient recruitment - A critical factor in your clinical trial

14 Apr 2016

During a clinical trial, it is important, that patient recruitment will progress as anticipated and in accordance with predefined timelines.…

Read more

The CE Marking process and Factory CRO

21 Mar 2016

The CE-mark serves the goal of free movement of many goods throughout the European Economic Area. You may have seen…

Read more

The ISO 13485 is updated, what is next?

21 Mar 2016

Learn more about how the ISO 13485 relates to the CE Marking process The display of a CE-mark on a…

Read more

Factory – the Fastest CRO!

10 Mar 2016

It is no coincidence that Factory CRO’s office is situated near the national park ‘the Utrechtse Heuvelrug’ – one of…

Read more

From Safe Harbor to Privacy Shield

29 Feb 2016

Since 2000, US companies were allowed to transfer data from the EU to the US, via the so-called "Safe Harbor”.…

Read more

Take care of personal (health) data!

26 Feb 2016

On the International Day of Privacy (28th of January), the Dutch Data Protection Authority (DPA) announced their surveillance calendar for…

Read more
  • 1
  • 2
  • 3

Annelies van Mourik

As a recruiter, I have seen a lot of different companies, and with large companies it’s always difficult to influence something or to get information, but at Factory CRO it’s easy to reach and communicate with the highest office.

Meet the team