CTMS Integration with Vestigo®: Enhancing Research Pharmacy Operations

CTMS’s Value to Research Pharmacy and the Impact of Connection with Vestigo^®

In recent years, the adoption of eSource and site-owned technology platforms has significantly transformed clinical research operations. These solutions empower research sites by streamlining trial operations, enhancing documentation capabilities, and improving overall trial execution. Importantly, they provide sites with more control over workflows and system integrations. However, as the number of technology platforms (“stacks”) grows, integration becomes essential to ensure interoperability, efficiency, and safety.

Challenges in Pharmacy Operations Without Integrated Systems

Research pharmacies, or Investigational Drug Service (IDS) pharmacies, are primarily responsible for investigational product (IP) accountability, dispensing, and inventory management. They rely on specialized electronic drug accountability (eDAR) platforms for daily operations. When research activities are distributed across multiple platforms—such as Clinical Trial Management Systems (CTMS) and electronic health records (EHR)—a lack of communication and synchronization creates redundant, manual processes. This leads to duplicate data entry, incomplete or delayed patient status updates, data misalignment, and potential errors, resulting in avoidable delays in study start-up, enrollment, and amendments.

The Role of CTMS in Supporting Pharmacy

A site’s CTMS serves as the operational “source of truth” for protocol data, study team rosters, and participant statuses (screening, enrolled, on study, off study). For pharmacy users, the most valuable CTMS features include:

• Protocol identifiers and attributes (e.g., sponsor, phase, local site number)
• Study team contacts and prescriber role designations
• Participant enrollment and status updates, as well as demographic changes influencing dispensing workflows and labeling

Pharmacy staff may be granted limited CTMS access to view protocol, staff, or patient enrollment data, obtain current protocol documents, or confirm completion of start-up tasks.

IDS Operations Within eDAR Systems

Despite robust CTMS capabilities, the pharmacy’s operational context is not fully captured within study operations systems. IDS teams must still manage:

• Drug builds, order builds, and label configurations tailored for investigational requirements
• Inventory control, including supply levels, lot/kit/expiration dates, quarantines, temperature excursions, and transfers
• Accountability and dispensing workflows to meet protocol and regulatory compliance
• Pharmacy eBinder documentation, such as shipping receipts, prescriptions, expiry memos, and temperature logs, accessible to monitors
• Scheduling and tracking monitor visits, capturing follow-ups and action items
• Competency and training records for protocol amendments

CTMS↔Vestigo® Integration: Linking and Synchronizing Data

Integrating CTMS with the Vestigo^® electronic drug accountability system connects protocol, contact, and participant data directly to pharmacy workflows. This integration yields tangible benefits:

• Simplified protocol creation in Vestigo^® via CTMS linkage, auto-filling core details from sponsor information
• Study team synchronization, including prescriber roles, ensures dispensing aligns with authorized clinicians. Keeping study coordinators, research nurses, and data managers up to date enables timely communication, and tracking staff start/stop dates provides traceability throughout the protocol lifecycle.
• Real-time participant enrollment and status updates keep pharmacy queues current, providing visibility into upcoming first doses or treatment changes so inventory and orders are prepared accordingly. When participants leave a study, pharmacy lists are updated for improved inventory management and compliance.
• Updates are delivered through scheduled synchronizations or on-demand refreshes, ensuring timely and accurate information. Notifications for participant enrollment and status changes appear in the Vestigo homepage alert queue, improving visibility and participant management.

Vestigo^®’s CTMS interface supports real-time updates for protocols, contacts, and participant information, with on-demand synchronization and CTMS-driven alerts tailored to research pharmacy operations.

Reliable Data Synchronization with Vestigo^®’s CTMS Interface

The Vestigo^® CTMS interface is designed to support repeatable, understandable, and auditable data movement, featuring:

• Scope: Synchronizes protocol header fields, site numbers, sponsor details, team contacts (including prescriber designations), and participant enrollment status
• Mechanics: Scheduled syncs for routine updates, and on-demand syncs for urgent changes (such as same-day enrollments)
• Visibility: Interface indicators and reports identify which protocols and contacts originated from CTMS, aiding troubleshooting and governance
• Traceability: All exchanges are logged, and audit histories are accessible to support inspections and sponsor reviews

Implementation Playbook for CTMS↔Vestigo^® Integration

McCreadie Group provides structured steps and resources for a smooth interface launch:

• CTMS Integration & Launch Checklist to coordinate connectivity, permissions, value mappings (status and roles), and test data loads
• Kick-off and mapping sessions with IDS stakeholders to align protocol information, contact roles, and prescriber authorizations
• Validation and cutover reports for protocol and contact verification
• Migration options for transitioning from legacy systems, combining interface setup with protocol and participant onboarding to ensure accurate protocol builds from the start

Getting Started: Key Steps to Prepare

• Assess your CTMS for interface availability with Vestigo^® and confirm endpoints and field mappings for protocols, team, and participants
• Define governance: clarify which system owns each field and standardize data entry in the source system
• Determine cutover sequencing if migrating from a legacy accountability system; many sites migrate first, then link the CTMS for ongoing synchronization
• Plan validation and user acceptance using Vestigo^®’s interface reports to verify mapped fields, roles, and updates

CTMS Alone vs. CTMS Integrated with Vestigo^®: A Comparison

Day‐to‐day need	CTMS alone	CTMS + Vestigo®
Protocol setup for pharmacy	Manual re‐entry into pharmacy system	Auto‐populate core fields; pharmacy adds drug/order builds only
Study team & prescriber logic	Managed in CTMS, not enforced at dispense	Synced roles enforce authorization at point of use
Enrollment/status updates	Reflected in CTMS only	Flow into Vestigo® to drive dispensing readiness
Accountability & inventory	Not designed for IP chain‐of‐custody	Purpose‐built workflows, standardized records, remote monitoring

Conclusion

For IDS pharmacy, CTMS demonstrates its value by supporting safe, standardized, and efficient workflows—aligning clinical research data with pharmacy operations. Integrating CTMS with Vestigo^® reduces manual data entry and duplication, streamlines processes, and enhances operational protocol management from initiation through study close-out.