Your Trusted Partner in Clinical Research Excellence

1. Clinical Monitoring & Site Management: 1.1. Site qualification, initiation, monitoring, and closeout 1.2. CRA oversight and co-monitoring 1.3. Source data verification and query resolution 1.4. Protocol compliance and site training 1.5. ISF/TMF QC and ongoing inspection readiness 2. Medical Monitoring & Clinical Development Support 2.1. Real-time safety review, AE/SAE assessment, and narrative support 2.2. Protocol development, amendments, and medical oversight 2.3. Medical review of eligibility, dosing decisions, and escalation criteria 2.4. Cross-functional collaboration with safety, biometrics, CMC, and regulatory teams 3. Quality & Compliance Services 3.1. SOP development and process optimization 3.2. RBQM frameworks, risk registers, and issue management plans 3.3. CAPA development and implementation 3.4. Mock inspections and health authority readiness 4. Site Engagement & Patient-Centric Services 4.1. Site training, tools, and resource development 4.2. Patient retention strategies and materials 4.3. Community outreach and engagement support 4. 4. Decentralized and hybrid trial readiness 5. Clinical Operations Leadership 5.1. Study planning, startup, and operational oversight 5.2. Cross-functional team leadership and vendor management 5.3. Timeline, budget, and risk management 5.4. Enrollment strategy and site performance optimization 5.5. Inspection readiness and regulatory compliance support