STEP 2: Your Study: The Process.
With one powerful package that includes rich features, highly-configurable functionality with fast implementation, VISION delivers a customized web-based service to meet all of your needs.
Development of your unique study requirements.
- In-depth collaboration with your team using your study protocol/CRFs to develop a comprehensive Study Requirements Document (SRD.)
- SRD - Data collection needs – forms, fields, edit checks, calculations, user permissions, study parameter specs - the primary tool used to ensure that your study is conducted to meet all of your needs.
- Validation - Prototype forms are created and sent to you for testing and approval. Changes are made and documented and, upon your approval, the final SRD is complete.
Specialized Tailoring of the system and visual adjustments are made to optimize your performance.
Tools and Features are personalized for your clinical team providing an intuitive and easy to use interface.
Electronic Case Report Forms (eCRFs) and other e-forms are designed to look like paper counterparts, if currently in use.
Custom Edit Checks provide real-time, built-in data accuracy and reliability, giving your study robust, streamlined performance.
Summary charts and tables are customized allowing you to check trends, track progress, and visualize your study’s success.
USER ACCEPTANCE TEST
Your custom system with unique solutions is launched for verification by your test team. Test scripts mapped to your SRD are provided as an aid to thorough testing of each form and field. If needed small adjustments are made and the system is ready to deploy.
The final study system is loaded onto a dedicated server in our secure data center. (link to security)
- User accounts are established
- Users begin training on duplicate database (available for the life of the study)
- Trained users are shifted to the real data base
You’re ready to “go live” with patient enrollment. Immediately your team will begin to see the benefits of real time data feedback.
For the life of your study, we provide backups and archives of your study data to guarantee the ultimate in data traceability and site control. In addition, help desk (link) personnel and our software architects are ready to assist you and answer any questions as you progress.
As your study progresses, trend charts may indicate additional information that would be advantageous to collect. VISION’s elegant architecture facilitates additions and modifications of data elements, edit checks and summary charts with ease unparalleled in traditional or competing software systems.
Batch Update - the system automatically applies updated edit checks to all forms and fields, saving time and ensuring more reliable data.
At the end of your study, we produce a final archive of your data and decommission of the study, removing all study data and user accounts. Archived data is sent to the sites and the Client.
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