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Clinical Trials

The MDR 2017/745 raises the requirements on clinical data compared to the previous status quo. Manufacturers will frequently have to conduct clinical trials in order to demonstrate conformity with the European regulations in terms of clinical safety, performance and clinical benefits.

Medical Mind RCS GmbH is specialised in the management of clinical trials for medical devices. Different from most CRO’s, our focus has always been in medical devices and we understand the needs of small to medium enterprises. Our team can support you by providing the following services, which will be tailored to your specific project needs.

Our Services for your clinical trials

 

  • Design, approval and management of clinical trials for medical devices in accordance with ISO 14155 and other applicable regulatory frameworks
  • Definition of endpoints in collaboration with key opinion leaders (KOLs) and sponsors
  • Statistics
  • Identification of investigators and study sites
  • Preparation of study documentation, including:
    • CIP (Clinical investigational plan (protocol))
    • IB (Investigator’s brochure)
    • CRFs (Case report forms)
    • SAE and AE ((Serious) Adverse Event) report forms
    • Informed consent
    • Supporting documentation
  • Competent authority and ethics committee submission and communication
  • Support of patient recruitment process
  • Data management/entry, validated database design
  • Scientific and regulatory training of CRAs (clinical research associates), investigators and study sites, organisation of site initiation visits
    • Study monitoring
  • Clinical evaluation reports to determine the objectives of upcoming clinical investigations