IRB Submission
Institutional Review Board (IRB) submissions are a critical part of clinical trial oversight, ensuring ethical and regulatory compliance. Our CTOps platform simplifies the entire IRB submission journey from initial reviews to amendments and continuing approvals. With intelligent templates, automated workflows, and centralized document control, teams stay organized, compliant, and always inspection-ready. Free up your clinical staff to focus on what truly matters: conducting quality research, not chasing paperwork.
Solution Features
Smart Document Linking
Auto-link consent forms, protocols, and investigator brochures to the correct IRB submission package to reduce duplication and human error.
Submission Status Tracker
Real-time status updates with visual progress bars and milestone indicators for transparency across all submission stages.
Centralized Submission Dashboar
One place to manage initial, continuing, and amendment submissions.
Version Control & Audit Trail
Track every change with timestamped audit logs and version histories.
Collaborative Workflow Management
Role-based access for PI, CRCs, and Regulatory Teams.
eSignature & Regulatory Compliance
Integrated 21 CFR Part 11-compliant eSignatures.
Key Benefits
Faster IRB Approval Turnaround
Minimized Compliance Risk
Improved Team Productivity
Increased Transparency
Seamless Integration
Please feel free to reach out to Us
Transform your study planning with AI-powered insights and custom templates. Contact us to schedule a demo and see Smart Study Design in action!