Services

Medvance is a specialist medical device consultancy group providing regulatory and clinical research services to clients on a global basis. Our clinical services include:

• 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
• Clinical Evaluations
• Auditing

Medvance also provides a range of bespoke training solutions to medical device companies including ISO14155, post market surveillance and the differences and similarities between device and pharmaceutical clinical research.
Regulatory services include:

• CE Marking process
• Liason with Competent Authorities
• Notifications for clinical investigations
• Clinical auditing services
• Clinical SOP writing
• Assistance in producing standard operating procedures