Timely and Cost Saving Medical Safety & Pharmacovigilance

RISK MANAGEMENT PLANNING & SAE MONITORING EXPERTS

The goal of safety monitoring is to identify, evaluate, minimise and appropriately manage product-related risk in a timely manner.

Our experienced Medical Safety & Pharmacovigilance team understands how the safety profile of a product critically impacts its development and ultimately, the regulatory approval process and beyond. We closely monitor reported safety issues to identify early safety indicators that can guide targeted safety evaluations across all product development stages. This benefits patient safety, enabling critical assessment of a product’s potential at an early developmental phase, potentially reducing costs.

Our Drug Safety & Pharmacovigilance division emphasises proven strategies for safety monitoring that rapidly establish risk/benefit balance and allows informed risk management planning.

Key features include:

• Systematic, patient-centred & active safety surveillance
• Expansive regulatory understanding across key global markets
• Expertise in ICH/GCP compliance & international standards
• Implementation of advanced technology solutions for adverse event reporting and auditing
• Timely communication of safety findings across multiple study sites and to all stakeholders

We have the expertise, people and procedures to ensure the safe clinical evaluation of every product.

Our comprehensive services include:

Study Start

• Safety management plans
• Site Training on SAE
• Reporting procedures
• Eudra Vigilance Profiles
• Edura Vigilance user registration
• Safety databases

Study Maintenance

• Case management and reporting
• Safety case management
• Patient safety management
• Adverse events collection, assessment and reporting
• SAE reconciliation

Study Close-Out

• SAE reconciliation
• SAE (CIOMS) report preparation
• SAE Summary report and distribution to sites