Vaishnavi Namade

I’m a B.Pharm graduate and an Advanced Diploma candidate in Clinical Research Management (6-domain program), currently deepening my expertise across Clinical Research, Pharmacovigilance, Clinical Data Management, CSV, Medical Writing, and Regulatory Affairs. I’m motivated by the discipline of compliant trial operations and the impact of high-quality data on patient safety.

In my recent work at Dysmech Clinical Services, I developed ICH-GCP compliant trial documents (ICF, CRF, Protocol) and prepared complete Ethics Committee dossiers for 3+ studies, achieving a 100% first-time approval rate. I also processed 25+ ICSRs using ICH-E2B(R3) guidelines, writing 15+ safety narratives while maintaining 7/15-day regulatory reporting compliance.

I bring strong clinical data and documentation control habits to every task. I maintained clinical data with 99% accuracy, executed CTAs/CDAs, supported site feasibility assessments for 4+ investigative sites, and authored 10+ regulatory documents using ICH-GCP along with CONSORT and PRISMA principles. I’m also experienced with audit-ready Trial Master File (TMF) practices.

I complement this operational experience with hands-on internship work and publication-level writing. I designed ICH-GCP compliant ICFs/CRFs, performed CRF data entry with 99% accuracy, conducted SDV, resolved data queries, and documented AEs/SAEs per ICH-E2B guidelines. As a first/corresponding author on a polyherbal formulation study, I strengthened my scientific writing, data analysis, and regulatory-compliant documentation mindset.