CTOps StudyX
CTOps StudyX USDM Digital Protocol Agentic Platform
Solution Features
Agentic AI-Powered Review
- Multi-Agent Collaboration: Specialized AI agents representing different domains (e.g., Regulatory, Safety, Statistical, Clinical) independently review the protocol and flag inconsistencies in real-time.
- Automated Content Consistency Checks: The system performs cross-referencing and ensures compliance with ICH E6 (R3), SPIRIT, and other regulatory standards.
- Intelligent Protocol Review: With AI-driven analysis, the platform suggests improvements, ensuring optimal protocol design.
Persona-Specific Views
Tailored Dashboards: Persona-specific dashboards (e.g., Medical Writers, Clinicians, Statisticians, Regulatory Managers) provide an intuitive user experience, enabling stakeholders to focus on their specific areas of interest.
Real-Time Notifications: Reviewers are alerted in real-time regarding discrepancies, non-compliances, or inconsistencies
Dynamic Digital Protocol
Digital Protocols: Switch seamlessly between machine-readable digital protocol views and human-readable formatted documents (e.g., ICH M11, TransCelerate Common Protocol Template, FDA/NIH Protocol Templates).
Cross-Document Traceability: Maintain bi-directional traceability across digital protocols and their human-readable versions for seamless collaboration.
Compliance Automation
Study Design Rubrics: Automatically calculate and benchmark study complexity, site burden, and patient burden using dynamic scoring models.
Amendment Impact Analysis: Evaluate the impact of protocol amendments and automate downstream updates to ensure compliance and accuracy.
Multi-Format Publishing: Publish protocols in multiple formats (eCTD, PDF, HTML, DOCX) while adhering to global regulatory standards.
Seamless External Data Integration
Data Source Integration: Easily integrate with external data sources (e.g., CTMS, EDC, eTMF), enhancing the review process with relevant insights and recommendations.
External Data Linkage: Enable direct connections to regulatory guidelines, industry standards, and benchmarking data for an enriched review process.
Benefits
Faster Protocol Review
- Reduce Review Time by 70%: Eliminate redundant manual checks and automate content validation, significantly speeding up the review process.
- Real-Time Updates: Ensure that amendments and updates are automatically integrated into the review process, minimizing delays.
Improved Accuracy and Compliance
- Automated Consistency Checks: Ensure that all protocols adhere to industry standards like ICH E6 (R3), SPIRIT, and FDA/EMA requirements.
- Full Traceability: Maintain complete traceability between digital and human-readable protocol versions, ensuring a robust audit trail.
Enhanced Collaboration
- AI-Driven Collaboration: Specialized AI agents provide contextual feedback and assist in cross-domain protocol review, reducing silos between stakeholders.
- Centralized Review Platform: Unify all protocol-related communication, ensuring that all reviewers and stakeholders are aligned.
Scalable and Future-Ready
- Scalable Architecture: Built to handle protocols for multiple studies, sites, and products without additional overhead.
- Ready for Integration: Easily integrates with TransCelerate’s Digital Protocol Exchange, Health Authority Review Portals, and other regulatory platforms.
How It Works
Data Ingestion:
External data (e.g., PDFs, Word docs, spreadsheets) are ingested into the system. The platform automatically extracts and structures the data, populating the relevant protocol sections.
AI-Driven Review:
The Agentic AI Layer utilizes specialized agents (e.g., Regulatory Agent, Safety Agent, Clinical Agent) to independently validate the protocol, flagging inconsistencies or potential issues.
Personal-Specific Dashboards:
The platform tailors the review experience to specific roles (e.g., Medical Writer, Clinician, Regulatory Manager), presenting only the relevant data and providing real-time insights.
Cross-Document Traceability:
Protocols are reviewed in a digital format, ensuring traceability across all versions. Reviewers can easily navigate between structured digital views and their traditional document counterparts.
Compliance Automation:
The platform automates compliance checks and computes complexity and burden scores. Protocol amendments are automatically updated, ensuring no data is missed.
Final Submission:
Once reviewed and validated, the protocol can be exported into multiple formats (PDF or DOCX), ensuring it meets regulatory submission requirements.
Use Case Example
Scenario: A global CRO managing multi-site clinical trials faced delays of up to 6 weeks in protocol review, primarily due to manual cross-referencing and content validation.
Solution: By adopting CTOps StudyX, the CRO was able to automate protocol review, generate filing-ready drafts in hours instead of weeks, and achieve real-time collaboration across stakeholders.
Outcome:
- Reduced protocol review time by 40%.
- Automated cross-referencing and content validation reduced errors by 30%.
- Enabled real-time feedback and collaboration across all departments, improving study execution efficiency.
Why Choose CTOps StudyX
CTOps StudyX · USDM Digital Protocol Agentic Platform is designed for the future of protocol review. With a focus on AI-driven collaboration, data standardization, and regulatory compliance, our platform accelerates clinical protocol review and transforms it into a transparent, auditable, and harmonized digital workflow.
Whether you’re a sponsor, CRO, regulatory agency, or clinical site, CTOps StudyX provides a comprehensive solution that improves compliance, speeds up protocol review, and facilitates smoother collaboration.
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