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ZM Company offers a broad array of services in Medical Affairs & Pharmacovigilance, Clinical Monitoring, Data Management, Medical writing, Training, and Consultation. We primarily specialize in:
-24/7 Medical monitoring
-SAE management
-SAE case narrative preparation
-Safety data review
-Medical data coding consistency review
-Scientific and medical review of Clinical Study Reports, Protocols, Clinical Development Plans
Clinical Monitoring
-Pre-study & initiation visits
-Monitoring visits
-Close out visits
-Source Document Verification
-Query management
- AE and SAE reporting
-Trial document handling
-Maintaining tracking reports
-Providing knowledgeable advice and support to the site
-Ongoing site education to protocol, GCP/ICH, & regulatory guidelines
-Administrative tasks
-CRF design and development
-CRF completion guideline development
-Medical data review (in-house and outsourcing)
-Medical data validation/edit check development
-Medical data coding
-SAE reconciliation
-Medical data quality control and audit
-Therapeutic area training and guidance
-GCP compliance training
-Lecturing, workshops, seminars
-Mentoring and staff development
-Trend analysis
-Protocols
-Study Reports
-Case Narratives
-Literature Reviews
-Posters and Abstracts
-Presentations |