RFP 187600330DP - Electronic Data Capture Solution

Background
The Virginia Commonwealth University (VCU) is seeking proposals for the implementation and ongoing support and maintenance of a 21 CRF Part 11 compliant Electronic Data Capture (EDC) solution. The EDC solution is intended to streamline data collection processes, ensure data accuracy, and facilitate real-time data access for clinical trials and research studies conducted by VCU.

Work Details
The EDC solution must comply with 21 CFR Part 11 requirements and include validation as part of the system license, with comprehensive documentation provided. It should provide tools for improving data collection efficiency and accuracy, ensure compliance with regulatory standards and guidelines, offer real-time data access and reporting capabilities, provide comprehensive training and support for end-users, handle off-schedule visits, manage cycles within studies, explore and analyze data efficiently, support electronic signatures in compliance with 21 CFR Part 11, maintain a complete audit trail, have the capability for rolling implementation of new EDC versions aligned with IRB approvals, blind specific users to certain data when necessary, use university Single Sign-On (SSO) for authentication, have cloud-based infrastructure for accessibility and scalability, store data within the United States, offer an open API for seamless integration with other systems, migrate data between the proposed tools and other systems as needed in the future, amend live studies and release updates to individual subject casebooks or entire sites without data migration, apply study amendments selectively to different sites without database downtime, unblind individual participants in emergency situations or on an as-needed basis, support multiple dictionaries including MedDRA and WHODRUG, upgrade dictionary versions mid-study, automatically code common terms (e.g., concomitant medications and adverse events), create and maintain customized data dictionaries, generate PDF documents for the archival of completed electronic Case Report Forms (eCRFs) at no additional cost. It should also provide manual query capabilities at form, question, visit, and subject levels; track and manage queries including capturing query metrics; view data and query simultaneously; identify and resolve data discrepancies effectively; support adaptive trial designs; link repeatable forms to other repeatable forms; provide auto-saving functionality to prevent data loss; display all forms with form status across subjects on a single screen; create repeatable forms within a single visit; create dashboards for data visualization and monitoring; lock/unlock data at various levels with a single command; manage lab normal ranges across studies; evaluate lab values against the correct normal range in real-time; provide operational reports including query management. Additionally it should offer Service Level Agreements (SLAs) that provide an excellent customer experience for both human touch points and system functionality.

Period of Performance
The initial contract term shall be the timeframe needed to complete implementation as agreed to by the parties in writing plus the initial three (3) years of licensing and maintenance. There is an option of up to two (2) two-year renewals.

Place of Performance
The contract will be performed at Virginia Commonwealth University.