Medical devices
 

Medical devices

Leading Clinical Research provides all of the services needed for clinical investigations of medical devices, whether the study aims at obtaining the CE marking or forms part of post-marketing surveillance.

There is a widespread misconception that there is no real difference between medical device and pharmaceutical studies. LCR knows the variances between these different types of studies and is able to provide you with specific services in compliance with effective directives, ISO and local regulations.

All of our Clinical Research Associates (CRAs) are trained in ISO 14155. Highly experienced and qualified clinical staff is able to assist you with your pre- and post-marketing studies:

  • Medical writing for clinical investigations (incl. Clinical Investigational Plan, ICF, Final Report)
  • Clinical Evaluations
  • Advice on study design
  • Case Report forms (eCRF)
  • Contract negotiations
  • Obtaining study insurance
  • Professional translations
  • Set-up and maintenance of TMF and study files
  • Submissions to Ethics Committees and regulatory authorities
  • Site selection
  • Site initiation visits
  • Site monitoring visits
  • Site close out visits
  • Data management
  • Statistics
  • Final report writing

Leading Clinical Research has also a certified Quality Management System compliant with the ISO 9001:2008 standard for the conduct and organization of clinical investigations.

One of the clinical investigations run by LCR was recently inspected by the local regulatory authority. We are proud that the inspection was without any finding!