Clindex CDMS/CTMS/EDC

Clindex CDMS/CTMS/EDC is a solution designed to streamline the clinical trial process by integrating a Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS), and Electronic Data Capture System (EDC). According to the vendor, Clindex is suitable for organizations of all sizes, ranging from small startups to large pharmaceutical and medical device companies. It caters to a wide range of professionals involved in clinical research, including clinical data managers, clinical research associates, study coordinators, and project managers. The product is widely used in the pharmaceutical and biotechnology industries, contract research organizations (CROs), medical device companies, as well as academic and research institutions.

Key Features

Data Issue Highlighting: According to the vendor, users can identify and generate data issues directly on the data entry screens, allowing for efficient resolution of discrepancies or errors during the data entry process.

Annotations Highlighting: Users can add annotations directly on the data entry screens to facilitate communication and collaboration among team members, providing additional context or notes related to specific data points, as claimed by the vendor.

Manual or Automatic Data Issue Creation: The vendor states that users can manually create data issues, such as queries or data clarification forms (DCFs), or configure the system to generate them automatically based on predefined rules or edit checks.

Advanced Edit Logic: Clindex incorporates advanced edit logic capabilities, allowing users to define complex validation rules and edit checks for data entry. According to the vendor, this feature ensures data accuracy and completeness by enforcing data quality standards and identifying potential errors or inconsistencies.

Intuitive Web-Style Interface for Remote Data Entry (RDE): Clindex offers an intuitive web-style interface for remote data entry, eliminating the need for physical presence at the study site and enhancing flexibility in data collection, as claimed by the vendor.

User Access Control for CRFs: According to the vendor, Clindex provides robust user access control, allowing administrators to define user roles and permissions. This feature ensures that only authorized users can access, sign, and modify Case Report Forms (CRFs), maintaining data integrity and compliance with regulatory requirements.

On-Screen Highlighting of Data Queries/Annotations/Modifications: Clindex highlights data queries, annotations, and modifications directly on the screen, making it easy for users to identify and address any data-related issues, as claimed by the vendor. This feature enhances user productivity and streamlines the data review and resolution process.

Simultaneous eCRF Access and Conflict Resolution: Clindex automatically detects if multiple users have the same electronic Case Report Form (eCRF) open simultaneously, according to the vendor. This feature ensures data integrity by allowing users to save their changes based on either the first save or first open priority, preventing conflicts and data loss.

Integrated System: Clindex CDMS/CTMS/EDC is a fully-integrated system that combines the functionalities of a Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS), and Electronic Data Capture (EDC) into one solution. According to the vendor, all data is stored in a single centralized database, eliminating the need for complicated interfaces and data transfers between different systems.

Flexible Customization: Clindex CDMS/CTMS/EDC is highly customizable to meet the unique requirements of each study and project team, as claimed by the vendor. Users can build custom forms, modules, and navigation to match their specific needs and preferences.