A unified clinical trial management platform with 28+ integrated modules and a regulatory document vault — designed to manage trials from startup to submission with AI-enhanced intelligence and global regulatory compliance.
Our CTMS & Regulatory Vault brings together clinical trial operations, quality management, regulatory document control, and AI-enhanced analytics in a single integrated platform.
AI-powered recommendations and predictive analytics that surface risks early.
CTMS, Regulatory Vault, and EDC in one integrated platform — no siloed systems.
Designed to support ICH-GCP and global regulatory standards with audit trails.
Manage multi-country trials with localized regulatory tracking and diversity metrics.
From study startup through submission — every aspect of clinical trial management in one connected platform.
Protocol-driven study setup, design, and lifecycle management across all phases.
Multi-site activation, monitoring, and performance tracking across global locations.
Enrollment tracking, subject lifecycle, and safety monitoring across all sites.
Adverse event tracking, SAE management, and safety signal detection.
Study and site-level milestones with planned vs. actual tracking and alerts.
Risk register with mitigation tracking and issue resolution workflows.
SAP authoring, review tracking, and alignment with study objectives.
Real-time statistical dashboards with enrollment trends and outcome analytics.
Electronic data capture with form builder, field validation, and real-time review.
CRO, lab, and service provider tracking with performance ratings and oversight.
Multi-channel patient recruitment with enrollment forecasting and ROI analysis.
Risk-Based Quality Management with critical data identification and tolerance limits.
Risk-Based Monitoring with adaptive strategies and SDV optimization.
Real-time centralized monitoring with automated alerts and cross-site trend detection.
Quality Management System with CAPA tracking, audit management, and deviation logging.
Custom study workflows with role-based assignments, approvals, and status tracking.
Connect external systems with configurable sync, authentication, and error monitoring.
AI-powered recommendations for site performance, safety, enrollment, and data quality.
AI-driven success probability scoring with risk factor analysis and predictive insights.
Checklist-based readiness scoring for regulatory inspections with gap analysis.
Global regulatory submission tracking with country-by-country approval timelines.
Enrollment diversity tracking with demographic analytics and inclusion goal monitoring.
Electronic document review and approval workflows with configurable routing and status tracking.
Investigational product supply chain with shipment, dispensing, and inventory tracking.
Site-level payment management with invoice tracking and milestone-based disbursements.
Site staff training tracking with completion monitoring and certification management.
Study startup task management with country activation and site feasibility tracking.
Portfolio-level executive dashboard with cross-study analytics and KPI monitoring.
A secure regulatory document vault with structured organization, electronic signatures, and bidirectional linking to CTMS studies.
Organized document repository with version control and audit trails.
E-signatures with signer identity verification and audit logging.
Seamless document linking between Regulatory Vault and CTMS studies.
Configurable review and approval workflows with role-based routing and status tracking.
Checklist-driven readiness scoring with completeness analysis.
Full version history with comparison, rollback, and comprehensive audit logging.
Automated document type classification with metadata management.
Configurable custom fields per document type for extended metadata and reporting.
Track documents across FDA, EMA, PMDA, and other global authorities.
Role-based access control with document-level permissions and organization scoping.
See how our CTMS & Regulatory Vault can accelerate your trials and streamline regulatory submissions.