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ClinVigilant EDC
Streamline Data Management process with most advance, robust and secure ClinVigilant EDC (Electronic Data Capture) Platform.
ClinVigilant EDC © Platform is consisting of various modules, each designed to handle different aspects of clinical trial data management processes. These modules work together to provide a comprehensive solution for researchers and cross-functional and cross-study data insight.

Why Choose the ClinVigilant EDC Platform?

Subject Matter Expert

Built by Subject Matter Experts

Scalable Solution

Flexible and Scalable Solution

Trusted Technologies

Regulatory Compliant

Key Features of

Study Design Module
  • Form Builder: Allows users to create and customize electronic case report forms (eCRFs) for data collection.
  • Protocol Management: Tools to define and manage study protocols, including visit schedules, inclusion/exclusion criteria, and randomization procedures.
  • Workflow: Design study specifications independent or complex workflow.
  • Scheduling: Allows to set up schedule of visits that comes in sequential manner, visit interval along with positive and negative deviations.
Data Entry and Collection Module
  • eCRF Completion: Interface for data entry, including features for entering patient data, lab results, and other relevant information.
  • Data Validation Rules: Functions to check data for completeness and accuracy, with alerts for any discrepancies or missing information.
Data Management and Query Module
  • Query Management: System for generating and managing queries to resolve data inconsistencies or missing data.
  • Data Cleaning Tools: Tools to assist in data verification and cleaning to ensure high-quality data for analysis.
Safety Monitoring and Adverse Event Reporting Module
  • Adverse Event Tracking: Features for recording and tracking adverse events and other safety data.
  • Safety Reporting: Tools to facilitate the generation and submission of safety reports to regulatory authorities and ethics committees.
Monitoring and Compliance Module
  • Audit Trails: Records all data changes and user activities to ensure traceability and compliance with regulatory standards.
  • Monitoring Dashboards: Dashboards for clinical monitors to review trial progress, compliance, and data quality.
Reporting and Analytics Module
  • Data Export Tools: Allows for the export of data in various formats for further analysis.
  • Statistical Analysis: Built-in statistical tools for analyzing trial data directly within the software.
User Management and Security Module
  • Role-Based Access Control: Defines user roles and permissions to ensure data security and restrict access based on user roles.
  • User Authentication: Secure login processes and user authentication to protect sensitive trial data.
Integration and Interoperability Module
  • System Integration Tools: Facilitates integration with other systems such as electronic health records (EHRs), ePRO, eConsent, Medical Coding, Lab Management, and clinical trial management systems (CTMS).
  • APIs and Data Exchange Formats: Supports various APIs and data exchange formats for seamless data transfer.
Patient Management Module
  • Patient Enrollment and Tracking: Tools for managing patient enrollment, tracking visit schedules, and managing patient information.
  • Randomization and Blinding: Supports patient randomization and blinding mechanisms, if applicable to the study.
Study Administration Module
  • Document Management: A repository for managing study-related documents such as consent forms, protocols, and investigator brochures.
  • Project Management Tools: Features to assist with the overall management of the clinical trial, including timelines, milestones, and resource allocation.

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