.svg){kind=icon}
At Ascendia Clinical, we deliver end-to-end GxP Audit Services at both the program and site level to safeguard the integrity, compliance, and quality of your clinical trials. Our experienced QA professionals conduct independent audits aligned with ICH-GCP, FDA, EMA, and other global regulatory standards. These evaluations are designed to identify risks, validate data accuracy, and confirm adherence to study protocols and SOPs.
To drive deeper insight and faster resolution, we integrate AI-powered auditing tools into our workflows. These technologies rapidly process large datasets to detect risk patterns, flag potential compliance concerns, and predict future issues—enabling a more targeted, responsive audit process with accelerated turnaround times.
TMF Quality & Documentation Audits: Evaluate system-wide compliance, documentation accuracy, and vendor oversight across multiple sites or clinical studies.
Site-Level Audits: Assess site-level readiness for regulatory inspections, focusing on protocol adherence, source data verification, informed consent processes, and staff training.
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 elevate the overall quality of their clinical programs—supported by the synergy of human expertise and intelligent technology.
At Ascendia Clinical, we leverage AI-driven insights to support the development, refinement, and optimization of clients’ procedural systems and documentation. Our intelligent solutions ensure regulatory compliance, enhance operational consistency, and enable proactive inspection readiness. By combining human expertise with advanced technologies, we tailor process systems to meet the unique challenges of each clinical program—empowering sponsors to achieve efficiency, transparency, and sustained quality throughout the research lifecycle.
At Ascendia Clinical, our Executive On Loan program offers sponsors agile access to high-level strategic leadership precisely when and where it's needed. We deploy seasoned executives—such as Chief Medical Officers, Regulatory Leads, and Clinical Operations Directors—into your organization to provide expert guidance, AI-informed oversight, and cross-functional leadership during pivotal phases of clinical development.
These executives bring more than just experience—they bring momentum. Many are accomplished female leaders with deep operational knowledge, collaborative mindsets, and a strong track record in regulatory success, team mentorship, and innovation. Their insight helps drive efficiency, enhance decision-making, and accelerate timelines by combining strategic foresight with real-time operational adaptability.
Whether you require interim leadership, targeted initiative support, or internal mentorship, Ascendia’s Executive On Loan service delivers flexible, intelligence-driven solutions that align with your project goals and empower lasting progress.
Reach out to our dedicated team for any inquiries, appointment scheduling, or support.
