Strategic EFIC consultation

Support begins with the protocol, study design, regulatory pathway, participating-site structure, and anticipated enrollment environment. The goal is to develop an EFIC approach that is ethically sound, operationally feasible, and responsive to sponsor and IRB expectations.

• Protocol and feasibility review
• EFIC pathway and implementation planning
• Central versus local operational strategy
• Timeline, resource, and risk assessment
• Preparation for sponsor, investigator, and IRB discussions

Community consultation and public disclosure

EFIC Support develops coordinated CC/PD programs that reach relevant communities, document community perspectives, and generate materials suitable for regulatory review.

• CC/PD strategy and campaign design
• Digital and community-based engagement
• Community survey development and implementation
• Demographic reach and representativeness assessment
• Community feedback analysis and reporting
• Initial and final public disclosure planning

Multicenter coordination

Multicenter EFIC studies require a consistent national framework and reliable local execution. Centralized support can reduce duplication, improve standardization, and give participating sites a clear operational pathway.

• Site onboarding and readiness support
• Standardized materials and implementation tools
• Site-specific campaign coordination
• Performance monitoring and issue resolution
• Documentation for central and local IRB review
• Network-level summaries and regulatory reports

Study closeout

EFIC responsibilities continue after enrollment ends. Closeout support includes final public disclosure planning, results communication, site coordination, and documentation of completed activities.

Discuss your trial

Services can be tailored to a single-site investigation, a multicenter clinical trial, or a national research network.