Medical Devices Expertise

Having 12 years experience with medical devices studies we have developed know-how to be very efficient in conducted projects. ClinMed’s extensive understanding of the medical device regulatory issues enables our clients save time and money with their studies. Our medical device experts have U.S. FDA as well as European regulatory experience and are flexible to address wide variety client’s demands.

ClinMed offers the following services:

Study start-up
  • Feasibility activities according to the Sponsor’s requirements based on the company’s expe rience and contacts with PIs and sites from the different therapeutic indications
  • Contract negotiation with study sites, investigators and contracted vendors
  • Preparation of essential documents (e.g. Patient Information Sheet and Informed Consent -Form, Patient’s Diary, Emergency Card, IMP label)
  • Preparation of Clinical Trial Application and submission to the Regulatory Authorities and to Ethics Committees
  • Pre-study visit
  • Medical Writing (Protocol, CRF, IB, IMPD)
  • Preparation of the Investigator files and Central Study File
  • Organization of the Investigators Meeting
Conduct of the study
  • Initiation, monitoring and close-out visits
  • Accompanied quality assurance visits
  • Booster visits to motivate site staff and reach the demanded recruitment rate
  • Payments to the hospitals and study teams according to the Sponsor’s requirements
  • Preparation of the Investigator files and Central Study File
  • Statistical analysis
  • Clinical Report
  • Publications

Clinical professionals outsourcing
Trainings e.g. ICH-GCP for Investigators, ICH-GCP for CRAs

Latest News

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Our next stem cells study
28 Jul, 2017

ClinMed is preparing to the next stem cells (ATMP) study…

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ClinMed starts phase II study with PET radiotracer
2 Jan, 2017

02.01.2017 ClinMed starts phase II study with PET radiotracer as…

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PET tracer study , Ph II full services
14 Sep, 2016

ClinMed has been selected for full services

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Stem Cells study in neurology, Ph I study design by ClinMed CRO Poland
1 Sep, 2016

ClinMed has been selected to develop study

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