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Clinical Safety Services > Reconciliation with Partners, Clinical Database

Reconciliation with Partners, Clinical Database

210,000+

Annual Cases Medical Triage & Review

99.99%

Submission Compliance

Expert Reconciliation of Safety Data with Clinical and Partner Databases

At Soterius, we specialize in safety and clinical data reconciliation with partners and Clinical Databases to ensure consistency, accuracy, and regulatory readiness. Our expert team supports seamless alignment between Safety and Clinical systems through tailored reports, intelligent tools, and automated workflows—empowering sponsors to achieve timely data lock and confident trial closure.
Streamlined Processes for Accurate and Compliant Reconciliation
Our reconciliation services are designed to proactively identify and resolve discrepancies across partner systems and clinical data platforms. By reducing manual effort and leveraging technology-driven solutions, we help ensure clean datasets that meet global regulatory expectations.

Why Choose Soterius for Data Reconciliation?

  • Specialized Expertise: Deep experience managing reconciliation across multi-partner studies and global trial environments.
  • Process Efficiency: Custom tools and workflows that accelerate reconciliation and reduce time to database lock.
  • Regulatory Compliance: Fully aligned with ICH, FDA, and EMA guidelines to support inspection readiness and submission success.
  • Regulatory-Compliant Reporting: Expertise in preparing standardized DSURs and ensuring safety data reconciliation aligns with global regulatory requirements.
  • Data Integrity and Accuracy: In-depth analysis and resolution of discrepancies in clinical and partner safety data to ensure consistency and reliability.
  • Streamlined Processes: Leveraging custom tools, automated workflows, and intelligent reporting.
  • Transparent Communication: Clear and accurate reporting of evolving safety profiles and clinical data to regulatory bodies, fostering confidence and inspection readiness.
  • Timely Compliance: Dedicated support to meet regulatory deadlines for DSUR submission and database lock, ensuring trial progress and regulatory success.