Our Medical Monitoring and Safety Department is dedicated to monitoring drug  and device safety in the interests of both patients and our sponsors. We have physicians located in the United States, United Kingdom and across Continental Europe who have medical research experience and understand and relate to the challenges faced at investigative sites.
 
Premier Research’s physicians provide 24-hour medical monitoring services, medical support for project management teams and sponsors as well as drug safety services. To meet stringent timelines for regulatory compliance, Premier Research provides a 24/7 safety service for the management of SAEs.
 
Premier Research’s Medical Monitoring and Safety Department has a global capability supported by detailed local knowledge and expertise. This ‘local’ presence means that the group has individuals fluent in local languages, medical practices and culture. Team members continually update their knowledge in response to evolving regulatory requirements with regard to patient safety in clinical trials. Since not all countries are at the same level of compliance, our knowledge and understanding of current individual country requirements is vital for ongoing study support.

Services

• Protocol, CRF and Patient Information Leaflets Design
• Interpretation of Laboratory and Other Safety Parameters
• Safety Plans
• SAE Reporting
• Patient Narratives
• Safety Reconciliation
• Electronic SUSAR/ICSR Reporting
• Production of Reports to FDA
• Generation of Periodic Reports
• Production of Annual Safety Reports
• Medical Coding
• Medical Data Review
• 24-hour Medical Monitoring
• DSMB Coordination
• Data Adjudication Committee Coordination 
• FDA Support
• Physician to Physician Interface
• Expertise in Medical Reporting in Europe
• Pediatric Support for PREA Compliance