Development Accomplishments

Handheld and Web Application—Streamlining the Clinical Study Process

Client: Contract Research Organization

Client’s Vision/Challenge

• Client chosen by pharmaceutical sponsor to conduct and manage an Electronic Data Capture (EDC) clinical study.
• Create a custom Palm PDA-based EDC application and a secure web portal. Provide mechanism to prevent data loss from the PDA.
• No internal resources to develop software.
• Roll out product in just 3 months in time for the first investigators meeting.
• Submit study results for publication within 10 months.
• Assemble team to train investigators on use of software at investigator meetings and provide help desk services throughout the study.

Why Customer Chose SST:

• Successful track record of working with client delivering software on time and within budget.
• Helped client clearly define product requirements.
• Extensive domain knowledge of software use for physicians.
• Experienced staff able to train investigators and staff the help desk.

Expertise:

• Handheld, Windows, and Web applications
• Tools: MS C++, ASP.NET, SQL, Palm OS, Code Warrior C++

End Result:

• Through the use of SST-developed technology the client achieved its accelerated study timeline. Within five months the client concurrently recruited, trained, and managed a large study and submitted the study results for publication less than one year after enrolling the first patients.

Features:

• Custom Palm EDC application including a password-protected login screen; eight eCRF pages, real-time edit checking, and an encrypted database.
• Secure web portal used to qualify sites for the study, to obtain contact information and study information, and to upload study data.
• Data encrypted and stored on a no-volatile Secure Digital (SD) card in the PDA’s memory card slot.