Office:
103 Carnegie Center, Suite 103
 
Princeton, NJ 08540,USA
Phone:
(609) 799-0021
Fax:
(609) 497-9695

 

 

 



 

 



 

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



Clinical Trial Safety Services

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 (several countries)

AE Report Management

  • Receipt, processing and narrative generation of adverse experience reports
  • Provide medical review of all AEs
  • MedDRA coding
  • Process expedited SAE/SUSAR reports using appropriate regulatory forms
  • Submit expedited SAEs/SUSARs 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

  • Providing access to online database of global pharmacovigilance requirements in over 100 countries
  • 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


 

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