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FDAnews: Postmarket Is CDRH's Top Priority, Official Says

Of all CRO's listed in the Applied Clinical Trials, Factory is the only CRO outside the US, specialized in Medical Devices

Factory is not only the best CRO but also the “fastest.” Factory CRO won the 10 kilometer Fortis City-Pier-City business run in The Hague

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Active in over 20 countries ›

  Clinical Trial Monitoring

Factory conducts field monitoring to ensure protocol and regulatory compliance and timely submission of high-quality data. Project Management
Frequent and direct communication is a prerequisite for optimal performance. Therefore an experienced Project Manager is in charge of each international trial and is your primary point of contact throughout the project

Monitoring
Our monitors/clinical research associates guarantee up to date knowledge of your trial status at each participating hospital. Our monitoring activities consist of:

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

SAE/AE reporting
Our MDs are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.

Clinical monitoring
One of the services that distinguish us from conventional CROs is our clinical monitoring service. We are proud to have experienced technical experts in different clinical fields who can provide monitoring of clinical procedures so that you can verify that your device is used as you intended.

12 Golden ISO14155 Rules for Medical Device Trials

ISBN 1-903712-24-6 by Prof David Hutchinson and Dr Joris Bannenberg Easy to read, illustrated, bullet point guide for sponsors and investigators doing trials on medical devices. The 12 ‘golden rules’ presented help investigators comply with the globally applicable ISO 14155 standards entitled Clinical Investigation of Medical Devices for Human Subjects (Parts 1 and 2). Also includes best practice advice.
£8  Canary books Internet bookshop


12 Golden EN540 Rules for Investigators of Medical Device Trials in Europe

ISBN 0 9531174 9 9 by Prof David Hutchinson and Dr Joris Bannenberg Easy to read, illustrated, bullet point guide for study site personnel doing trials on medical devices. The 12 ‘golden rules’ presented help investigators comply with the EN540 standards regulating trial conduct.
£5  Canary books Internet bookshop