Services

Pharmacovigilance Services

 Medical Consulting/Monitoring Services

•  An experienced physician provides medical oversight and review for clinical studies. Roles and responsibilities are tailored for each client. 
• 24/7 availability to clinical sites for emergency safety issues.
• Site interactions for clarification or queries on protocol specifics or study conduct, such as inclusion/exclusion queries, concomitant medications, or adverse event management or reporting.
• Review of safety data on an ongoing basis to identify potential risks or safety signals.
• Review of safety listings to ensure accurate serious adverse event reporting.
• Review of SAEs with provision of causality assessments and regulatory recommendations.
• Coding reviews to ensure accurate and consistent data for the study and program.
• Participation in Data Safety Monitoring Boards or Safety Review Committees.
• Medical review of final study reports, DSURs, PSURs, RMPs, and dRMPs.
• Individual case report and aggregate safety reviews.

Comprehensive Safety Case Management

• Ongoing serious adverse event management from study onset to study completion. Our work is aligned with your needs and expectations. Flexibility to adapt as needed based on trial objectives and findings.
• Establishment of client-specific Safety Management Plans to outline workflow and communications.
• Serious adverse event processing by trained medical pharmacovigilance personnel resulting in high-quality, cost-effective consistent safety narratives and regulatory reports.
• Quality review to ensure that each case is correct and compliant.
• Various safety database options to meet each client’s needs.
• Timely and accurate regulatory services.
• Reconciliation of clinical and safety databases to ensure accuracy across the study.
• Full service or tailored solutions.

Safety Committee Management Services

• Through an extensive pool of physicians in various specialties, we provide the physicians needed for Data Safety Monitoring Boards or Safety Review Committees.
• We have the experience needed to create the charter needed for these committees to clearly identify roles and responsibilities and processes.
• Coordinators manage the committees including member contracts, charter approval, meeting organizations and documentation, data transmission, and close-out.