Regulatory & ethics submissions
IRB/EC submissions and essential document tracking that keep activation timelines predictable, feeding into regulatory document management.
What's included
What goes into submission support
- IRB/EC submission packages prepared and tracked from initial application through approval
- Essential document collection reconciled against the study's regulatory binder requirements before submission
- Submission status tracked against activation timelines, with escalation when a site's approval risks slipping
- Approved documents handed off complete to regulatory document management
Site readiness
Coordination with site management and EDC build teams so sites are trained and system-ready by the time regulatory clearance lands.