What is CTMS?
CTMS is a next-generation Clinical Trial Management Software designed to streamline and digitize the entire clinical trial lifecycle. Built for both global studies and niche research, CTMS simplifies trial planning, improves site collaboration, ensures regulatory readiness, and delivers real-time visibility into study performance.
​
Whether you're managing a Phase I trial or a multi-country Phase III program, CTMS helps accelerate timelines, improve quality, and control costs—while staying inspection-ready.
SALVUS COMPLAINT TO 10+ PHARMACEUTICAL REGULATORY AGENCIES
Core Capabilities

End-to-End Trial Management
Study startup planning and milestone tracking
Site identification, feasibility, and activation
Document management and version control

Advanced Analytics & Reporting
Study performance dashboards
Enrollment, retention, and protocol deviation metrics Customizable reports for executive and regulatory use

Smart Monitoring & Oversight
CRA visit tracking and trip reports
Centralized issue and deviation management
Risk-Based Monitoring (RBM) and alerts

Designed for the Life Sciences Industry
Pharma & Biotech SponsorsContract Research Organizations (CROs) Academic Medical Centers & Research Sites

Resource & Budget Management
Investigator payments and budgeting tools
Vendor oversight dashboards
Real-time financial and accrual reports

Regulatory Compliance & Data Integrity
ICH GCP E6(R2) and 21 CFR Part 11
GDPR, HIPAA, and other data privacy frameworks ALCOA+ data integrity principles
Centralized Oversight and Site Collaboration
Faster Time-to-Insight
Reduced Risk of Non-Compliance
Centralized Oversight and Site Collaboration
Data-Driven Decision Making
Simplified Audits and Inspections

INTEGRATED PLATFORM
Integrations
Signum integrates effortlessly with:
​
-
EDC platforms (e.g., Medidata, OpenClinica)
-
eTMF and document repositories
-
eCOA/ePRO systems
-
Safety databases like Salvus and Argus
-
Master data hubs and SSO systems

.png)
