Factory is a contract research organization (CRO) specialized in organizing and monitoring clinical studies on medical devices and biological products.
They provide the following services to the medical device and biological product industry:
* Consultancy
* Conduct of pre-clinical and clinical studies with devices and biological products
* Data management of clinical study data
* Independent QA auditing
* Statistical analysis and report writing
* Assistance in registration of medical devices and biological products
* Outsourcing of clinical research staff

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Factory has experience in the preparation and execution of different medical device trial designs including 'phase I-IV' clinical trials, Safety & Performance studies, efficacy studies, effectiveness studies, clinical economic studies, Quality of Life studies, and Post Marketing Studies.

We have performed multi-centre clinical trials with 20 to 300 patients per study, recruited by 2 to 20 participating investigators in up to 8 different European countries. Follow up periods for clinical device trials vary from 1 month to 2 years depending on the calculated safety risks of the device.

We are experienced in evaluating devices in a number of different surgery disciplines,
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