Worldwide Drug Safety and Pharmacovigilance Services
PRS Safety and Pharmacovigilance Services provide a dedicated team of safety
professionals with extensive experience in worldwide drug safety and pharmacovigilance,
and an understanding of the changing regulatory environment. Our staff can provide you
with services for managing safety reporting during all aspects of clinical trials,
post-marketing surveillance and consulting for Pharmacovigilance. Whether you want to outsource all your pharmacovigilance activities or a specific
function, PRS provides the following services based on your needs:
Clinical Trial Safety Services
Post-Marketing Surveillance Services
Pharmacovigilance Consulting Services
EudraVigilance Reporting
Clinical Trial Safety Services
Create and maintain a safety database
- Database maintenance in a PRS hosted commercial safety application or remote data entry
directly into sponsor's safety databases (commercial or proprietary)
SAE Report Management
- Receipt, processing and narrative generation of serious adverse experiences,
pregnancies and endpoints
- Provide medical review of all SAEs
- MedDRA coding
- Provide unblinding
- Process expedited SAE reports using appropriate regulatory forms
- Notifications to investigators
- Submit expedited SAEs to regulatory authorities within required timeframes globally
Annual safety reports preparation (USA, EU)
Post-Marketing Surveillance Services
Qualified Person for Pharmacovigilance
Create and maintain a safety database
- Database maintenance in a PRS hosted commercial safety application or remote data entry
directly into sponsor safety databases (commercial or proprietary)
AE Report Management
- Receipt, processing and narrative generation of adverse experience reports
- Provide medical review of all AEs
- MedDRA and coding
- Process expedited SAE reports using appropriate regulatory forms
- Submit expedited SAEs to regulatory authorities within required timeframes globally
Provide medical information services for literature review
Provide signal detection and/or identification of trends
Prepare periodic safety update reports and ad hoc reports requested
by Health authorities
Provide label reviews for consistency with safety data
Risk management program design and implementation
Pharmacovigilance Consulting Services
- Pharmacovigilance audits
- Review and evaluation of in sponsor's drug safety processes and SOPs
- Preparation of standard operating procedures and working practices related to organization, infrastructure,
and workflow for pharmacovigilance activities
- Pharmacovigilance training
- Assist is preparation of safety data exchange agreements and distribution agreements
- Review and/or preparation of safety sections of regulatory documents
- Consult on safety requirements globally
EudraVigilance Reporting
- Provide electronic reporting into EudraVigilance
- Individual Case Safety Report submission to the EU Eudravigilance database
(EMEA-trained user of the database)
- Medicinal Product registration in the EU’s Eudravigilance database
(EMEA-trained user of the database)
info@pharmregservices.com
|
