epasssolutions.com

What It Is

ePASS is an Electronic Data Capture System (EDC) for commercial clinical research. Its core goal is to help clinical trials reduce data collection time, improve accuracy, and lower costs. It is a 100% Web-based system, so users only need a PC and an internet connection—no client software installation is required.

Core Features and Collaboration Permissions

In terms of functionality, ePASS covers study build, eCRF design, clinical data and patient information entry, Edit Checks for data validation, query management, site monitoring, dataset freezing, database lock, and PI review and electronic signature. Data is organized by study protocol and study site. Authorized users can be assigned for each study and site, with support for differentiated roles and permissions. The roles mentioned in the source text include Site User, Monitor & Data Management, and PI, broadly corresponding to the clinical trial workflow of data entry, monitoring/data management, and investigator sign-off.

Security, Compliance, and Deployment

For security, ePASS provides electronic audit trails, access restrictions, username/password authentication, electronic signatures, and 128-bit SSL encryption. It states that clinical research data is encrypted when transmitted to the ePASS servers, and that data entered by end users is not owned by ePASS. On the operations side, the system undergoes regular performance, security, and reliability testing, and daily server backups are performed. Backups are retained for one year and can be restored within minutes. It is worth noting that the source text does not explicitly list specific certifications or regulatory alignments such as 21 CFR Part 11, HIPAA, or ISO 27001.

Pricing, Integrations, and Developer Capabilities

Pricing information is limited. The product only emphasizes “reasonable” and “cost effective pricing,” without providing plans, quotes, billing metrics, or a free trial. Third-party integrations, APIs, developer documentation, and data import/export capabilities are also not described in the source text. This makes it harder to evaluate how well it can connect with CTMS, eTMF, drug coding, statistical analysis, or data warehouse systems.

Pros, Cons, and Best-Fit Users

Its advantages are simple web-based access, coverage of key EDC workflows, and faster study startup through coding modules and a reusable eCRF library. Its drawbacks are the limited public information on commercial terms, integrations, and certifications, making it difficult to judge its suitability for large multinational trials based only on publicly available text. It is better suited to clinical research teams, CROs, or study sites that need basic to moderately complex EDC capabilities and value rapid database buildout and site usability.

Access from China and Alternatives

The source text does not provide information on network access from China, payment methods, or local service availability, so its access status should be considered unknown. If conducting clinical research in China, it is important to confirm cross-border data requirements, server location, regulatory compliance, Chinese-language support, and payment options. Comparable alternatives include Medidata Rave EDC, Oracle Clinical One, Veeva Vault EDC, Castor EDC, REDCap, and OpenClinica.