VitaWay Research LLC. Medical consulting services email: vitawayresearch@gmail.com

A highly qualified physician-scientist, a founder of VitaWay Research LLC, with a deep understanding of the industry and drug development, knowledge of clinical development guidance and regulatory requirements, decades of practical clinical development experience leading and executing R&D oncology projects in hematologic and solid tumor malignancies, offers and provides a medical consultant service dedicated to early- through late Phase I-IV clinical development Areas of expertise - Hematologic and solid tumor malignancies, endocrinology, and internal medicine. - Strategic and operational trial planning, study design, protocol development, feasibility, study initiation, conduct, execution, study closure, submission, and approval - Leadership, oversight, medical monitoring of US and global clinical trials - Clinical, safety, efficacy data review, evaluation, interpretation, analysis, reporting - Design, implementation of medical review & safety monitoring plans, DMC charter, imaging charter, required study documents - CTCAE, MeDRA, medical coding; tumor assessment evaluation per RECIST, mRECIST, Lugano Classification, Owen criteria - Support with development of ICF, eCRF, RAVE, EDC, TLFs, intext-tables - Team trainings, presentations at investigator’s meetings - Study data analysis, presentation to Data Monitoring committees (DMC), Steering committees (SC), Safety committees, Advisory boards, internal/external stakeholders - Integrated clinical, safety, efficacy analysis and clinical study reports (CSR) - Collaboration with trial multifunctional teams for timely milestones delivery, data integrity, risk management, data quality control - Interactions with FDA, EMA, health / regulatory authorities, ECs, DMCs, SCs, KOLs - Medical support with IND, NDA, ODD submissions, PMRs, Investigator’s brochure - Mentor and support trial teams, clinicians, junior colleagues - Knowledge and compliance with ICH, GCP, and regulatory requirements - Publications and peer review