Humanitas Clinical Research Inc.


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Services offered in USA, Canada and Europe:


  • Selection of clinical sites and investigators, phase I-IV clinical trials.

  • Assistance with TPD submission, regulatory documents collection and review (including review of the Consent Form).

  • Assistance with study budget negotiation.

  • Site training and management. Primary contact for study sites and communication gateway for the client.

  • Monitoring activities: Qualification, Initiation, Interim and Close Out Visits. Submission of Visit Reports within 10 working days of the monitoring visit.

  • Reporting and verification of Serious Adverse Events.

  • Assure adherence to Good Clinical Practices, SOPs and study protocols.

  • Data clarification and correction.

  • Liaison with vendors, CROs, regulatory authorities. Provide professional support to European companies that want to open business offices in Canada.

  • Regional, Lead and Senior CRA available.