Reliable PV Delivered
with High-touch
Customer Service
Our Pharmacovigilance team combines deep expertise with customized processes to deliver rigorous safety reporting. With dedicated project leads, technology integration, and seven-day global coverage, we ensure efficient case management and exceptional client support.
What We Offer
Everest provides a full range of clinical trial pharmacovigilance and drug safety services, including:
Safety Case Management and Processing
- 7-day-a-week global case processing team based in North America and Europe
- Drug safety monitoring and management of clinical trial safety events, including SAEs, AESIs, device incidents, and pregnancies
- Study-specific Safety Management Plan, including PV procedures and documentation
- Setup and maintenance of sponsor-, compound-, and study-level Oracle Argus safety database
- Full case processing: triage, data entry, quality review, relatedness/expectedness assessment, narrative writing, medical review and coding, and submission
- Investigator manual for reporting events and automated safety notifications through our EDC alert system
- Safety database migration, including Safety Data Transfer Agreement development and case import
Regulatory Report Delivery and Data Handling
- Electronic regulatory report generation (CIOMS, MedWatch, XML)
- Safety regulatory submissions and central IRB/IEC submission support for reportable safety events
- Submission experience with FDA, EMA, Health Canada, MHRA, and Eastern Europe
- EudraVigilance Responsible Person services and system setup
- Dissemination of SUSARs via Everest Investigator Safety Notification System, including “Dear Doctor” letter and automatic read-receipt tracking
- SAE reconciliation between safety and clinical databases
- Periodic line listings and annual safety report tables/listings
Technologies
We use proven, industry-standard tools that allow us to operate efficiently while maintaining the highest quality standards:
- Argus Safety Database: Robust and scalable platform for case management and regulatory reporting
- EDC to Argus Integration: Enables a streamlined case intake and a seamless flow of data.
- Investigator Safety Notification System: Secure portal for real-time SUSAR notifications to investigators and tracking acknowledgements
- Regulatory Monitoring Technology: Tools and processes for tracking evolving global PV requirements to ensure ongoing compliance
Why Choose Everest for Your
Safety Monitoring and Reporting?
High-Touch Service
Our small team model ensures personal, attentive support. You work directly with senior safety experts and medical monitors who are deeply familiar with your programs and can provide hands-on guidance.
Experienced, Dedicated Team
Seven-Day Global Coverage
In-House Database Management
High-caliber Project Management
