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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.