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CRO Services - proDERM as a SMO

proDERM has a network of qualified investigators in hospitals and private practices. In this way, we are able to organize multicenter trials with up to 8 centers as the responsible CRO.

Of course, proDERM can take over all aspects of a study, from the study plan to obtaining regulatory and ethics approvals, monitoring, data management and statistics to the report.

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Quick Info
  • Simultaneous application at the leading and all
    other involved Ethic's committees (EC)
  • Formal check of the leading EC within
    10 days (there is 1 leading EC for each
    involved country)
  • Content check of each incolved EC
  • Decision of the leading EC within 60 days
  • Information about the background of
    the study
  • Discussion of protocol and CRF
  • Training and comparison on investigators
  • Discussion of AE/SAE information procedure
  • Monitoring
  • Timeplan
  • Garantee of well-being and rights of the subjects
  • Conformity with the protocol
  • Check of investigator site files
  • Informed consent form
  • Check of cource data and CRF
  • Study medication and emergency plans
  • Administration of findings and queries
  • Audits of documentation, data capture, data analysis
    and report writing

Within the initiation of a study site the following topics are discussed / checked:

  • Protokol
  • CRF
  • ICF
  • Randomisation
  • Study medication
  • AE/SAE-Procedure
  • Timeplan
  • Recruitment
  • Monitoring-visits
  • Responsibilities
  • Archiving
  • ISF