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About Clinical Research Consultants

Clinical Development Strategy and planning (CDP, Protocol, CSR), Phase I–III Clinical Trials, Protocol Design & Development. Medical Monitoring, IND / CTA / NDA Submission, Dose Escalation / SAD-MAD Studies. Biomarker Strategy & Translational Science, Regulatory Affairs (FDA, EMA, etc.), CrossFunctional Leadership (CRO, Biotech, Pharma), KOL & Investigator Engagement, Data Safety Monitoring Boards (DSMB), Informed Consent / eCRF / I/E Criteria, Rare Diseases / Cell & Gene Therapy / Immuno-oncology / RNA gene Therapy. Acted as the primary sponsor medical lead, directly engaging with regulatory authorities (FDA, EMA) to present clinical development plans, respond to inquiries, and lead regulatory meetings, including Type B/C and End-of-Phase interactions. • Served as the main clinical escalation point for site investigators and operational teams, ensuring clinical consistency, patient safety, and rapid resolution of protocol deviations or site-level challenges. • Provided continuous medical monitoring across studies—reviewing patient profiles, assessing eligibility, managing safety signals, supporting coding decisions, and ensuring data integrity in coordination with Data Management and Safety teams.

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