CLININFO CTMS
Protocol Deviations

Simplifying the declaration, tracking, and resolution of deviations across studies

Monitoring Reports

Streamlined workflows that save time in creating, reviewing, and approving reports.

Progress Tracking

Powerful tools to visualize, manage and anticipate monitoring progress in real time.

EDC Integration

A unified ecosystem connecting monitoring activities and clinical data in real time.

Our aim

Streamline the management of protocol deviations, ensuring that they are captured accurately, tracked effectively, and addressed on time, to maintain study quality, compliance, and provide actionable insights for clinical operations.

Our offer

Easy Deviation Reporting

Protocol deviations declared and tracked rapidly, reducing administrative burden.

EDC Integration

Sites can report deviations directly on the CRF, ensuring real-time data capture.

Action Plan and Deadline Tracking

Actions and timelines are monitored with priorities and deadlines clearly defined.

Integration in Monitoring Reports

Deviations can be declared and closed directly from monitoring reports.

Customizable Deviation Categories

Categories can be tailored to each study, improving classification and analysis.

Integrated Exports with Clinical Data

Deviation data can be exported alongside clinical datasets, supporting analysis.

Our aim

Make monitoring report management fast, accurate, and collaborative by providing intuitive online tools, configurable workflows, and secure signatures.
The module ensures high-quality reports while reducing administrative overhead for CRAs and study teams.

Our offer

Fully Customizable Reports

Reports can be created using sponsor or CRO standard templates.

Simple and Intuitive Online Entry

Data entry is performed directly online, making report completion fast and easy.

Online Discussion via Comments

Teams can add comments directly within the report, similar to Word comments.

Review and Approval

Configurable review and approval processes to meet study requirements.

Compliant Online Signature

Reports can be signed electronically in a secure and regulatory-compliant manner.

Final PDF Generation

A finalized PDF report is generated, ready for distribution or archiving.

Our aim

Provide complete visibility on monitoring activities, allowing study teams to plan efficiently, track workload, and adjust strategies dynamically.
By centralizing progress data, operational decisions are faster and more accurate.

Our offer

Workload Estimation Tools

Easy estimation of monitoring efforts for each site and study

Real-Time Monitoring Calculations

Monitoring activities from EDC are fetched in real time to feed the progress calculation.

Custom RBM Strategy

Integration of study-specific risk-based monitoring strategies for optimal oversight.

Monitoring Visit Planning

Anticipate and schedule future monitoring visits based on calculated workload.

Adjustable Estimates and Simulations

Simulations allow recalibration of monitoring plans based on real progress.

Multi-Level Views

Progress is visualized across study, country, site, and CRA levels.

Our aim

Ensure seamless alignment between clinical data and operational monitoring.
By tightly integrating the CTMS with the EDC, information is shared consistently, strategies can be adjusted dynamically, and monitoring activities remain fully synchronized with study data.

Our offer

Connected Modules

Accounts, sites, subjects, and forms are shared to ensure data consistency.

Automatic Linking of eCRF Monitoring

eCRF monitoring activities are automatically associated with CTMS records.

Dynamic RBM Configuration

Risk-based monitoring settings can be adjusted, with real-time impact on eCRF.

Customizable KRIs

Key Risk Indicators can be configured to identify underperforming or at-risk sites.

Clinical Data Exports Integration

Deviations and actions can be exported alongside clinical datasets.

Open APIs

APIs can be implemented to connect the CTMS with external systems when needed.

Smart Monitoring Operations

Streamlined services for efficient, real-time monitoring operations

The Ultimate Monitoring Report Solution

A single, seamless workflow covering everything from report creation to compliant electronic signature.

Our aim
Reinvent monitoring report management through radical simplicity, by removing friction at every step, from data entry to review and signature, monitoring reports become faster to produce, easier to validate, and fully compliant by design.
Key Capabilities
  • Adaptation to internal procedures and standard documents of sponsors and CROs.
  • Multiple configuration options available for report entry, review, and approval workflows.
  • Report entry is fast, intuitive, and ergonomic, with built-in commenting for seamless collaboration.
  • Electronic signatures and finalized PDFs fully comply with regulatory requirements.

Real-Time Operational Control

Instant visibility and proactive oversight to keep studies on track at all times

Our aim
Transform study oversight into a real-time, actionable experience, by continuously synchronizing operational and clinical signals, project teams are empowered to anticipate issues, react faster, and maintain full control without added complexity.
Key Capabilities
  • Intelligent alerts notify project teams when situations require immediate attention.
  • Operational metrics updated in real time based on EDC activity.
  • Accounts, sites, subjects, and data automatically shared with the EDC.
  • Ongoing deviations and action items remain clearly visible at all times.

Tailored Monitoring Strategy

A flexible monitoring approach aligned with study risks and operational reality

Our aim
Enable monitoring strategies that truly fit each study, by combining configurable RBM rules, real-time insights, and proactive tracking, monitoring efforts are continuously optimized to focus where they matter most.
Key Capabilities
  • Risk-based monitoring rules directly impact eCRF monitoring activities.
  • Resolution of actions is tracked to ensure timely follow-up.
  • Monitoring progress is anticipated and monitored to avoid delays or surprises.
  • Customizable KRIs help identify at-risk sites early.

Advanced CTMS Tools

Smart, flexible tools designed to streamline clinical trial operations and decision-making.

Single Sign-On (SSO)

Centralized and secure access to all studies, allowing users to move seamlessly between projects.

Smart Alerts

Intelligent alerts that proactively flag situations requiring the project team’s attention.

Customizable Email Notifications

Fully configurable email notifications to ensure each role receives the right information at the right time.

Modular Usage

A flexible, modular CTMS where you only activate and pay for the functionalities that match your operational needs.

Clear and comprehensive audit trail

A complete, readable audit trail that ensures full traceability and supports regulatory audits and inspections.

Customizable exports and reports

Advanced reporting capabilities with exports and summaries tailored to your operational workflows.

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Complete Clinical Software Ecosystem

A wide range of seamlessly connected solutions to cover every aspect of your clinical study.

eCRF

Rapidly deploy and customize your study data capture.

ePRO

Capture patient-reported outcomes efficiently and remotely.

IWRS

Simplify randomization and study drug management.

CDMS

Centralize and clean study data in real time.

eTMF

Manage essential documents securely and compliantly.

CTMS

Track study progress and monitoring easily.

Regulatory Compliance

Our solution ensures full regulatory compliance, with secure, auditable, and reliable clinical data management.

FDA GCP GDPR HIPAA
ISO HDS SOC

See Your Study Come to Life

Discuss with our experts about your study, test a custom sandbox, and see how our solution can be tailored to your needs.

Request a Demo