Clinical Services

Our highly experienced and qualified clinical staff are based all over the world and are able to assist you with your pre and post market studies:

• Production of all the documentation you will require for your study including:
  Investigator Brochure
  Clinical Investigation Plan (protocol)
  Case report forms
  Patient consent documents
  Institution agreements
  Study master file
  Investigator site files
• Clinical Evaluation/Literature Review
• Advice on study design
• Statistics
• Research Ethics Committee submissions
• Competent Authority Submissions
• Selecting appropriate study sites
• Study initiation visits
• Study monitoring
• Study close down
• Data management
• eCRF
• Report writing (final report, publications, presentations)
• Obtaining study insurance
• Translation of study documents

Whether your study is for collection of safety and performance data for CE marking or for post market surveillance activities we are here to help you.