Our client is a research-based biopharmaceutical company that discovers, creates, and commercializes innovative medicines in areas where medical needs are met.
Multiple tracks and reviews of a clinical study before submission to the regulatory body cost both money and time.
The client was looking for some tool to reduce the trial development life cycle.
We conceptualized the txDesigner application
The Web-based application was created with SSL 128 encryption
The design complied with the guidelines
of FDA – 21 CFR Part 11
The application supported PDF generation based on ALS and helped visualize the study design
The application yielded platform-independent and ODM-compatible output
Prior knowledge of EDC system
Visibility to those responsible for all stages of study build
Collaboration challenges during the study development phase in a geographically distributed teams
The trial design and build time reduced by 50%
Form development efforts reduced by 90%
Paper-based approval process became electronic
Mobile version (for iPad) for the application
Studies organized by therapeutic areas
Generation of unit testing results for validation