Contract Research

AMR is a full-service contract research organisation based in Europe.

We are specialising in clinical studies on orthopaedic implantable devices.

We work according to ISO 14155 and have in-depth knowledge of all relevant regulatory requirements around device trials.
We are set up to assist you in all aspects of your study, including
- study design
- first regulatory submission
- surgeon / patient / centre recruitment
- data collection / data management / data interpretation
- final reporting
- closeout
- post-market surveillance

Competence and experience

Year-long experience in the industry can make the difference!

Most CROs claim they have clinical research expertise in the field of medical devices. We, however, have the experience with AMR staff having managed hundreds of pre-market, post-market, interventional and observational studies in multiple European countries. We have the development and regulatory know-how to execute successful device trials (pilot, pivotal and post-surveillance studies) across all risk classifications and approval pathways.

  The way to do research is to challenge the facts at the point of greatest astonishment Peter Fennema

Our services

Our services include the following:

  • Studies and trials
  • Interventional trials (pre-market, post-market) 
  • Observational trials
  • Safety surveillance
  • Registry type studies
  • Study design and project management
  • Surgeon and centre recruitment
  • Study design input and review 
  • Optimisation of endpoints and scoring systems
  • Preparation and review of study documentation (e.g. protocols, clinical investigation brochures, eCRFs, patient information letters, informed consent forms, etc.)
  • Competent authority and ethics committee submissions and liaison
  • Database design and validation
  • Study monitoring (initiation visits, routine intra-study visits and close-out visits)
  • Preparation of monitoring outcome reports
  • Data collation and database input
  • Data queries handling, analysis and manipulation
  • Final report and study master file compilation
  • Project management of clinical studies