CTMS

WCG eResearch Enterprise CTMS is a clinical trial management system designed to support research sites through all phases of a clinical trial, from study start-up through close-out. It is built to automate administrative, financial, and research activities, and is used by academic medical centers, hospitals, health systems, and independent research sites. The platform aims to provide a single source of truth for coordinators, reduce duplicate data entry, and support integration with electronic health records and other enterprise systems.

The system addresses three core areas: integrated operations across technologies, financial and regulatory oversight, and coordinator and participant management. It includes a participant portal for remote engagement and self-reporting, and supports simultaneous management of multiple studies.

Study Setup and Initiation

• Protocol definition and study calendar configuration
• Document storage and study team management
• Budget creation and coverage analysis
• Case report form (CRF) design
• Status tracking and submission review

Participant Management

• Coordinator portal for study oversight
• Participant profiles and status tracking
• Consent management
• Visit tracking and deviation tracking
• Participant portal for remote engagement and self-reporting

Financial Management

• Charge master configuration
• Milestone tracking
• Accounts receivable and accounts payable management
• Invoicing, payment processing, and reconciliation

Clinical Data Management

• Electronic data capture (EDC)
• Electronic case report forms (eCRFs)
• Data monitoring and query management
• Data validations

Reporting and Dashboards

• Standard dynamic reports and ad-hoc queries
• Study dashboards and finance dashboards
• Data monitoring and query management dashboards
• Actionable intelligence reporting

Reported Outcomes

• 80% reduction in time spent on data entry
• 21% improvement in site financial results
• 29% increase in participant retention rates
• Over 200 system integrations, including 50+ with Epic

Integrations and Interoperability

• Open platform with extensive APIs supporting EMR integrations, including ADT for demographics, RPE for protocol and subject information exchange, and IHE CRPC billing designations
• Integrations with Epic, Cerner, GE, Meditech, Siemens, Allscript, Warehouse, Click, InfoEd, Pro IRB, iMedRIS, IDX, Peoplesoft, Lawson, Workday, and others
• Standard and custom integrations with IRB platforms, financial systems, clinical systems, and regulatory systems
• Compatible with WCG eSample for biospecimen management and WCG Participant Portal for remote participant engagement

Onboarding Process

1. Project kick-off meeting scheduled with the site team and key stakeholders
2. Project scope discussed and a high-level draft project plan presented
3. Working sessions scheduled to cover system configuration and integration options
4. Live virtual training scheduled for the site's super user or administrator
5. Weekly project meetings established with the site project team
6. Working sessions with subject matter experts provided for best-practice guidance
7. Access to the test eResearch application provided to the site admin two weeks after kick-off
8. Project plan reviewed and updated through ongoing weekly meetings

Security, Compliance, and Hosting

• Compliant with 21 CFR Part 11 and HIPAA
• Maintains a privacy policy covering privacy by design, data privacy impact assessments, and data rights requests
• Available as a secure cloud-hosted deployment to reduce security, maintenance, and licensing burden on sites
• On-premises hosting option also available
• Data migration services provided for sites transitioning from spreadsheets or other legacy systems