Regulatory strategy, submissions, site activation and study start-up aligned with applicable European requirements and ICH-GCP principles..
Strategic site identification and feasibility assessments to select high-performing sites and accelerate study start-up.
Risk-based remote and on-site monitoring focused on patient safety and data integrity. throughout the trial lifecycle..
Study coordination, timelines, vendors, documentation and operational oversight..
Recruitment strategy, patient engagement and enrollment support.
Quality oversight, compliance, safety monitoring and pharmacovigilance support.
