Safety Monitoring Services

Azelix offers turnkey pharmacovigilance services to monitor, assess and report on the safety of investigational products and detect any change to their risk-benefit profile. We work closely with sponsors, sites and regulators to assure compliance against all relevant reporting requirements. Our flexible solutions are tailored to meet the needs of your project or program with safety and compliance remaining a top priority.

Our services include:

• Development of Safety Management Plans
• Processing of SAEs and Other Events of Interest
• Regulatory Report Submission for SUSARs
• Data Reconciliation
• Line Listing and Summary Tabulation Generation
• Signal Detection
• Safety Database Hosting
• Investigator Meetings
• Data Safety Monitoring Board Management and Participation
• Health Hazard Evaluations
• Protocol Development
• Audit and Advisory

Medical Monitoring

Medical monitors play an important role throughout the trial. Azelix’s medical monitors participate in discussions as early as the pre-IND stage contributing to the overall drug development strategy and ensuring that it meets the current needs of patients. Our team then continues to provide guidance on protocol design and the selection of appropriate inclusion and exclusion criteria and other safety-related feedback to ensure that your protocol are well-balanced from the regulatory, operational, and patient safety perspectives.