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At Ascendia Clinical, we offer comprehensive Audit Services at both the program and site level to ensure the integrity, compliance, and quality of your clinical trials. Our experienced QA auditors conduct independent evaluations aligned with ICH-GCP, FDA, EMA, and other global regulatory standards to identify potential risks, ensure data accuracy, and verify adherence to protocols and SOPs.
Program-Level Audits focus on overall system compliance, vendor oversight, TMF quality, and trial master documentation across multiple sites or studies.
Site-Level Audits assess individual investigative sites for regulatory readiness, protocol adherence, informed consent processes, source data verification, and staff training.
To enhance the precision and efficiency of our audits, we incorporate AI-powered assessments into our process. These advanced tools analyze large datasets to detect patterns, predict risk areas, and flag potential compliance issues in real-time—allowing for more targeted auditing and faster resolution.
We provide clear audit findings, actionable recommendations, and follow-up support to drive continuous improvement and inspection readiness. With Ascendia Clinical, sponsors can confidently maintain compliance and strengthen the overall quality of their clinical programs—supported by both human expertise and intelligent technology.
At Ascendia Clinical, our Procedural Document Systems are powered by a robust Quality Management System (QMS) designed to ensure consistency, compliance, and continuous improvement across all clinical operations. Our QMS governs the creation, management, and maintenance of essential documents including Standard Operating Procedures (SOPs), Work Instructions, Policies, and Quality Manuals.
Built on industry best practices and aligned with global regulatory standards (GCP, ICH, FDA, EMA), our document control processes provide clear guidance to internal teams and external partners. Through version control, audit trails, and secure access, we maintain document integrity and ensure that all team members are working from the most current procedures.
With Ascendia Clinical’s QMS-driven document system, sponsors gain peace of mind knowing their clinical programs are supported by a solid foundation of quality and operational excellence.
Ascendia Clinical offers an Executive On Loan program that allows sponsors to access high-level strategic leadership on a flexible, as-needed basis. This unique service places seasoned executives—such as Chief Medical Officers, Regulatory Leads, or Clinical Operations Directors—directly within your organization to provide expert guidance and oversight during critical phases of your clinical development.
We are proud to feature accomplished female executives in this program—leaders who bring a wealth of experience, cross-functional expertise, and a collaborative mindset. These executives offer fresh perspectives, drive innovation, and support decision-making with a balance of strategic vision and operational know-how.
Whether you need interim leadership, mentorship for internal teams, or targeted project support, Ascendia Clinical’s Executive On Loan service delivers trusted expertise that empowers your team and accelerates progress.
Reach out to our dedicated team for any inquiries, appointment scheduling, or support.