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CRO Services

Site Management and Monitoring

For medical device and IVD projects, DLC site management and monitoring services include:

  • Site qualification visits
  • Site initiation, routine monitoring and close out visits
  • On site, remote and risk-based case report form (CRF) review/source document verification
  • Attendance to device implantation sessions in surgery suites
  • Hospital equipment/instrument verification and personnel training
  • Assessment of protocol compliance and protocol deviations
  • Monitoring of serious adverse event reporting
  • Site support, including routine telephone and e-mail contacts
  • Assistance to investigators in preparing required reports for the Ethics Committees / Institutional Review Boards

 

DLC clinical research associates (CRAs) have consolidated device experience and can access our team of medical or regulatory affairs experts throughout the project, so that any study-related issue can be addressed in a timely and effective manner.

Please contact us for further information or assistance.

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