Safety Data Exchange Agreement (SDEA)

A Safety Data Exchange Agreement (SDEA) is a vital compliance document that defines the responsibilities, timelines, and procedures for exchanging pharmacovigilance data between partners—such as sponsors, CROs, distributors, and license holders. Ensuring accurate and timely safety data exchange is essential for meeting global regulatory requirements and maintaining product safety throughout its lifecycle.

At Adaptis, we offer end-to-end SDEA management services tailored to your operational structure and global partnerships. Our team collaborates with stakeholders to draft, negotiate, implement, and monitor SDEAs that ensure regulatory alignment and operational clarity.

Our SDEA Support Includes:

• Product-Specific SDEA Development
• Collaborative Agreement Negotiation
• Timeline Definition & Periodic Review
• Monitoring of Compliance with Agreement Terms
• Stakeholder Training and Implementation Support
• Ongoing SDEA Maintenance and Audit Readiness

We bring a strategic and practical approach to managing SDEAs—helping you streamline safety data workflows, reduce compliance risks, and maintain transparency across your pharmacovigilance partnerships.