TrialStat EDC is a scalable Electronic Data Capture suite designed for clinical trials, including pilot studies and all phases of drug development, as well as medical device and diagnostic studies. It enables efficient data collection and real-time monitoring through a web-based platform, reducing errors and overall study costs while ensuring compliance with regulatory standards.
Funding
Funding not disclosed
Founders
Product
Problem
Clinical trials often face challenges in efficiently capturing and managing data, leading to increased study costs and potential errors. Traditional Electronic Data Capture (EDC) systems can be complex, costly, and may not fully integrate with other essential clinical trial functions.
Solution
TrialStat EDC is a hosted Electronic Data Capture (EDC) suite designed to streamline data collection and monitoring for clinical trials across all phases, including pilot studies, drug development, and medical device/diagnostic studies. The platform offers a unified eClinical suite, integrating EDC with Interactive Web Response System (IWRS), electronic Patient-Reported Outcomes (ePRO), and medical coding within a single, interoperable system. By using the latest technology, TrialStat EDC allows complete system access via any web browser or mobile device, facilitating efficient data capture, real-time insights, and reduced study costs. The platform's modular design allows sponsors to add functionality as needed, while custom development services can accommodate unique study requirements.
Target Audience
The primary customers are pharmaceutical, biotechnology, and medical device companies, as well as Contract Research Organizations (CROs) and data management companies, seeking a comprehensive and scalable EDC solution for managing clinical trial data.
Features
- Scalable EDC suite suitable for pilot studies through Phase IV trials, as well as medical device and diagnostic studies
- Fully unified eClinical suite integrating EDC, IWRS, ePRO, and medical coding
- Integrated IWRS functionality for randomization without the need for a separate system
- ePRO module to combine site data with patient data, eliminating the need for third-party systems and data reconciliation
- Medical coding module enabling data managers to utilize WhoDrug, MedDRA, and custom dictionaries directly within the EDC
- Vendor Neutral Imaging Archive (VNA) for managing medical images
- Real-time data visualization and reporting with configurable reports and dashboards
- Compliant with regulatory requirements such as FDA 21 CFR Part 11, HIPAA, GDPR, and FISMA
- Custom development services to meet unique study requirements
- Mobile device accessibility