- 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.
|