Teams at Ergomed PLC

Lead regulatory management for international clinical trials: develop Regulatory Management Plans and study-specific FMEAs, prepare and submit CTAs/amendments/notifications/reports, liaise with regulatory authorities and sponsors, review CSRs for regulatory compliance, provide regulatory training, and line-manage small regulatory teams.

Manage clinical data activities for trials: design CRFs and databases, program/test edit checks, perform coding (MedDRA/WHO‑Drug), export CDISC SDTM datasets, generate queries, coordinate data entry and DB developers, support database lock and sponsor communication.