txDesigner

Study trial management system that reduces trial design and build time by 50% compared with paper-based designs.

 

Client Background

  • 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.

The Solutions

  • 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

 

 

 

 

 

 

The Challenges

  • 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 Business Impact

  • The trial design and build time reduced by 50%

  • Form development efforts reduced by 90%

  • Auditability improved

  • Paper-based approval process became electronic

Road Ahead for Case Management Prototype

  • Mobile version (for iPad) for the application

  • Studies organized by therapeutic areas

  • Generation of unit testing results for validation