ClinResearch offers its clients monitoring according to the standards
of ICH assuring that
- The rights and well-being of human subjects are protected
- The reported trial data are accurate, complete and verifiable
from source documents
- The conduct of the trial is in compliance with the currently
approved protocol/amendment(s), with GCP and with the applicable
regulatory requirements.
ClinResearch provides the following monitoring services:
- IRB notification and IEC approval
- Investigator site selection
- Investigator qualification and training
- Prestudy document collection and review
- Study initiation
- Periodic monitoring visits
- Drug storage and accountability
- Telephone monitoring
- Data verification and query resolution
- Study termination visits
Dedicated team of project managers and clinical research
assistants (CRAs) who
- Are full-time employees of ClinResearch
- Project Managers average at least 10 years of education and
experience in pharmaceutical instustry.
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