Peter Hmel

Background

About Peter Hmel

Project manager and certified clinical research professional with a research and development background in the life sciences. Aficionado of acronyms.Specialties: Clinical trial execution from SQV to writing FCSR, study-start document production (CP, CIP, DMP, CMP, IB, ICD), on-site/remote monitoring with SIV and 100% SDV during IMV, investigational drug/device packaging/labeling (QTE and BPR approval) and JIT shipping/accountability with IDS (DARs using Vestigo, nCoup etc.), API analysis and CofA/CofC review, EDMS/EDC database programming and CDISC-compliant eCRF design with eCOA/ePRO including UAT/validation through database lock, IWRS implementation for inventory, dispensing, randomizing, blinding and programming, TMF structure and upkeep (eISF using Veeva, Florence, RedCap, etc.), DMC/DSMB organization and executive secretary service, WHODrug Global and certified MedDRA terminology coding, SAE/SUSAR reporting, pre-IDE/IND, INTERACT (formerly pre-pre-IND), IND/IDE/BLA and Q-submissions and supplements including CMC, IRB/EC/IBC/HRPO coordination, GxP compliance with virtual/in-person audits, IQ/OQ/PQ validation, PDUFA meetings (attendee at Type A/B/C), Clinicaltrials.gov PRS administration for 801 and final rule, eCTD formatting, TPP/PI development, PK/PD/PM analyses particularly for FIH studies.