+39 06 5782665
contact@donawa.com

CRO Services

Study Design and Protocol Development

Through the combined work of regulatory, statistical and medical writing experts DLC supports medical device and IVD companies in:

  • Defining study design, objectives, endpoints and sample size according to applicable US and/or European regulatory requirements
  • Developing/reviewing clinical protocols for studies with medical devices in accordance with EN ISO 14155:2011
  • Developing/reviewing protocols for IVD performance evaluation studies in accordance with with US and/or European requirements
  • Developing protocols for post market clinical follow up (PMCF) studies

Please contact us for further information or assistance.

This website uses cookies and asks your personal data to enhance your browsing experience.