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Patient safety is paramount in each and every clinical trial. The physicians, nurses, and pharmacists in our global Pharmacovigilance department provide safety support through all stages of our clients’ clinical trials. To meet stringent timelines for regulatory compliance, Premier Research provides a 24/7 safety service for the management of SAEs and employs Oracle Adverse Event Reporting System (AERS).
We have staff located in the United States and Europe who have clinical research experience and understand and relate to the challenges faced at investigative sites. Our staff 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 have the same regulatory reporting requirements, our knowledge and understanding of current individual country requirements is vital for ongoing study support.
Services
- Safety Management Plans (SMPs)
- SAE Reporting
- Patient Narratives
- SAE Reconciliation
- Electronic SUSAR/ICSR Reporting
- Generation of Periodic Reports
- Production of Annual Safety Reports
- Medical Coding
- Medical Data Review
- 24-hour Medical Monitoring
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