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CRO

Clinical monitoring

Clinical Trials / Projects preparation:

  • to develop plans for the research project
  • to carry out feasibility analysis of the planned project
  • to identify suitable investigators and sites
  • to develop the protocol
  • to prepare in the CRF in a suitable design
  • to compile the patient information sheet and informed consent
  • to adapt and translate the contracts, manage the required insurances

Ethical and Regulatory Approval:

  • we manage the complete ethical and regulatory approval procedure, including all required amendments of the protocol

Conducting and closing the project

  • to organize all investigator's meetings
  • to carry out the initiation visit, manage monitoring and required adverse event reporting (AE, SAE)
  • to manage site closure and resolve all queries
  • to manage data processing, coding and statistical analysis

Translation of clinical- and research texts
Preparation of summary reports
Professional preparation and management of computerized CRF systems

Study coordination

As part of the initiation of clinical trials projects, we execute the following activities:

Clinical Trials / Projects initiation:

  • to identify the suitable patient population
  • to find and contract the required human and other resources for the study
  • to prepare all sites for the study

Ethical and Regulatory contacts:

  • to coordination the AE / SAE reporting
  • to follow-up and track all reports

Management of clinical trials:

  • to organization and track all visits of enrolled patients
  • to handle the source documentation
  • to complete all CRF-s (electronic and paper based as well)
  • to keep contact with external participants (laboratories, radiology, CT, etc.)
  • to coordination between all related participants

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Medical Devices CRO