Zensara offers a generative AI platform that automates clinical trial data management by generating case report forms, edit checks, and database models, significantly reducing setup time from months to minutes. The platform ensures compliance with HIPAA and global regulatory standards while providing customizable study designs and seamless integration of electronic data capture tools.
Funding
Funding not disclosed
Founders
Product
Problem
Clinical trial data management is a time-consuming process, often taking months to set up case report forms (CRFs), edit checks, and database models. This manual work delays study launches and increases operational costs for research teams.
Solution
Zensara offers a generative AI platform that automates the clinical trial data management process, significantly reducing setup time. The platform uses AI to generate CRFs, edit checks, and database models from study protocols in minutes. Zensara provides a comprehensive suite of electronic clinical outcome assessment (eCOA), electronic patient-reported outcome (ePRO), electronic consent (eConsent), and wearable integrations, all within a single platform. The platform is designed to ensure compliance with HIPAA, 21 CFR Part 11, and other global regulatory standards.
Target Audience
Zensara is designed for clinical research teams, pharmaceutical companies, and research institutions seeking to streamline their clinical trial data management processes.
Features
- Generative AI-powered creation of CRFs, edit checks, and database models
- Customizable study designs with full flexibility for protocol changes and database lock
- Comprehensive suite of eCOA, ePRO, eConsent, and wearable integrations
- Tailored localization to support multiple countries and languages
- Autonomous trial management capabilities for instant study design, launch, and amendments
- Compliance with HIPAA, 21 CFR Part 11, and global regulatory standards