CLININFO CDMS
Effortless CRF Design

Design powerful CRFs without technical complexity, from setup to audit readiness.

Sites and Users

Open, close, and manage sites and users with full control and traceability.

Built-In Medical Coding

Reliable, consistent medical coding embedded directly into your CDMS workflows.

Reporting & Data Exports

Flexible outputs to support day-to-day operations and downstream analyses.

Our aim

Enable fast, reliable CRF configuration without programming skills, while supporting advanced logic, traceability, and full audit readiness throughout the study lifecycle.

Our offer

Excel-Based CRF Setup

Configure CRF variables directly in Excel, with no programming skills required.

Smart Data Logic

Define prefill rules, cross-page data transfers, and simple or advanced automatic calculations.

Intuitive Edit Checks

Configure edit checks using clear, intuitive syntax with full logical and arithmetic operators.

Annotated CRF Generation

Automatically generate annotated CRFs in PDF, including schedules, conditions, and variable names.

Flexible Mailing Lists

Manage email alert distribution lists (safety, sponsor, teams) and update them anytime.

Audit-Ready Documentation

Access online specifications, validation records, and change control documentation at any time.

Our aim

Simplify day-to-day study operations by providing clear, flexible control over users, roles, and site access, while maintaining full traceability and compliance throughout the study lifecycle.

Our offer

Flexible User Profiles

Predefined roles fully customizable to match each study's organization and responsibilities.

Easy Account Management

Create, update, or deactivate user accounts quickly, without technical complexity.

Site Lifecycle Control

Open or close sites centrally to reflect study progress and operational decisions.

Login History & User Support

Track user access and activity to support audits, investigations, and assist users.

Simplified User Review

Clear, centralized user listings to support periodic access reviews and compliance checks.

One-Click Study Lockdown

Switch studies to read-only or fully close access instantly at study end.

Our aim

Ensure accurate, consistent, and efficient medical coding by seamlessly integrating standard and custom dictionaries into the CDMS, reducing manual effort while supporting data quality, safety reporting, and regulatory readiness.

Our offer

MedDRA Coding

Standardized coding for adverse events, supporting safety and regulatory submissions.

WHO Drug Coding

Coding for concomitant medications, ensuring consistency across sites and datasets.

IMDRF Device Coding

Structured IMDRF coding for medical devices, adapted to device-focused and hybrid studies.

Custom Dictionaries

Integration of simplified or study-specific dictionaries when needed.

Auto-Coding Support

Auto-coding based on prior entries and direct dictionary matches, reducing manual workload.

Validation & Listings

Clear coding listings and review tools to verify completeness, consistency, and coding quality across the study.

Our aim

Provide ready-to-use and customizable reporting tools that give teams full visibility on study progress, while enabling fast, reliable, and compliant data exports for monitoring, data management, safety, and analysis.

Our offer

Built-In Study Dashboards

Native reports covering patients, forms, queries, monitoring activities, and signatures.

Excel-Ready Reports

All reports exportable to Excel for easy manipulation and integration in any software.

Custom Reports

Study-specific reports designed on request and reusable across multiple studies.

Flexible Data Exports

CDISC/CDASH compliant exports with extensive configuration options for analysis and submission needs.

Audit-Ready PDF Exports

Compliant PDF outputs for sites and archiving, including full audit trail information.

Operational XLSX Outputs

Clean, practical Excel exports tailored for data management and safety teams.

Empowered Study Operations

Tools that give sponsors and CROs full control, autonomy, and real-time responsiveness.

Operational Autonomy

Full control over your study, without daily dependency on external teams.

Our aim
Empower sponsors and CROs with true operational autonomy across study setup, conduct, and close-out, enabling faster decisions, smoother workflows, and reduced reliance on support teams.
Key Capabilities
  • Full autonomy to configure CRFs and study settings without technical expertise.
  • Independent management of sites, users, roles, and account lifecycle.
  • Direct control over data review and query management, from creation to closure.
  • Autonomous data exports, soft locks, and final database freeze at study close-out

Real-Time Site Support

Empowering teams to assist sites directly, quickly, and safely.

Our aim
Enable sponsors and CROs to efficiently assist investigational sites with real-time visibility and direct actions, reducing delays, preventing errors, and improving overall study execution.
Key Capabilities
  • Real-time access to study activity and data for immediate site support.
  • Direct visibility on entered data, with controlled deletion of incorrect patients or forms.
  • Query closure and form freezing or unfreezing without operational bottlenecks.
  • Password resets and personalized emails sent directly to site users.

Personalized Study Tools

Create tailored access, monitoring rules, reports, and data exports with ease.

Our aim
Enable sponsors, CROs, and study teams to adapt the CDMS to their unique workflows, ensuring precise control, efficient monitoring, and flexible reporting.
Key Capabilities
  • Access and permissions fully customizable to user roles and study requirements.
  • Monitoring and DM review rules adjustable, including optional automation for efficiency.
  • Custom reports designed to match study-specific metrics and reused across studies.
  • Flexible SAS/CSV data extracts for any CRF subset, with saved selections for repeated use.

Advanced CDMS Tools

A comprehensive set of tools to simplify data management and streamline operations.

Bulk User Import

Automatically load user accounts from a simple, standardized Excel file.

Batch Database Control

Re-run database checks automatically after any addition, modification, or deletion.

Data Interventions Toolkit

Easily delete or restore forms and patients, and manage queries.

Audit Trail Explorer

Intuitive interface to view, filter, and export categorized audit logs.

Interactive Charts

Default or customized charts to track patient enrollment and data quality.

Flexible Soft Lock

Precisely select forms or patients to soft lock, with rules-based automation and easy unlocking.

Contact Us to Learn More!

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