Clinical development success requires thoughtful planning, operational oversight, and ongoing risk management.
I provide quality-focused support throughout the trial lifecycle to ensure protocols are followed, data are reliable, and processes meet GCP and regulatory expectations.
I provide independent oversight and support for pharmacovigilance systems and processes. This includes safety system audits, vendor assessments, and gap analyses aligned with global requirements such as ICH E2E and GVP modules.
My focus is on ensuring timely reporting, accurate data capture, and appropriate risk management practices.
