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?

Built by Subject Matter Experts

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.