Suvarna Kolhe

I bring 16+ years of hands-on site management experience across global Phase III–IV cardiac clinical trials, acting as the primary contact between sponsors, CROs, and the investigational site. I manage study initiation through close-out with full compliance to ICH-GCP, company SOPs, and applicable regulatory guidelines.

Over the years, I’ve facilitated 50+ CRA on-site monitoring visits by ensuring inspection-ready essential documents, complete training records, and organized source/access for reviews. I also support risk-based monitoring by partnering with CRAs and Local Trial Managers to resolve data quality issues, protocol deviations, and compliance risks while driving timely milestone achievement.

I’m proficient in Florence eTMF, Medidata Rave, Oracle InForm, SUGAM portal, IWRS, and eCOA/ePRO, and I’m responsible for AE/SAE reporting, CAPA implementation, query resolution, and eTMF/archiving readiness. I coordinate AE/SAE documentation and narratives within required regulatory timelines and manage IP accountability, ensuring accurate reconciliation across source, EDC, and regulatory records.