Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
On-site/remote visit execution, SDV/SDR and follow-ups per the client monitoring plan.
Document readiness, submissions & responses in coordination with sponsor/CRO.
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
ICSR intake/processing, E2B checks, QC & medical review support per client safety SOPs.
Tell us about your sites and monitoring plan and we’ll come back with a staffing and coverage proposal.