Pharmacovigilance Services

 

What is Pharmacovigilance in a Clinical Trial? 

Pharmacovigilance in a clinical trial is the process of monitoring and evaluating the safety and efficacy of a drug or medical device during the clinical trial stages. It involves collecting, assessing, and reporting adverse events or other safety-related data that may occur during the conduct of the clinical trial. The goal of pharmacovigilance is to ensure the safety and well-being of the trial participants and to mitigate any potential risks associated with the use of the investigational drug or 

medical device. The data collected during pharmacovigilance is also used to inform regulatory agencies and healthcare professionals about any safety concerns related to the drug or device. 

   

Obatica Pharmacovigilance Services 

Obatica will work with you to design the study protocol and to establish procedures for monitoring adverse events and other safety issues. During the study, our PV team will review data and make recommendations for modifying the protocol if necessary, based on emerging safety concerns or other factors.  

Book in for your free consult here to learn more about our pharmacovigilance services.

 

Our pharmacovigilance team offer a range of services including (but not limited to): 

• Investigational site training on study-specific safety reporting requirements 

• Safety database setup / sponsor database setup 

• Study-specific document preparation 

  • • Safety Management plan 
    • Safety reporting plan 
    • Safety reporting forms 
    • Investigational site guidelines 
• Data Management 
  • • Data entry
    • Medical coding (MedDRA, WHO Drug Dictionary) 
    • Medical review 
    • Query Management 

• Safety reporting 
  • • Local regulatory authorities and ethics committees (IRB/HREC) 
    • SUSARs, Significant safety issues, urgent safety measures 
    • PSUR (Periodic Safety Update Report/DSUR (Development Safety Update Report) 
    • Annual Safety Report (AU) 
    • Cross-study reporting, if applicable 

• Distribution 
  • • To investigators/study memo 
    • IB update 
    • Protocol update 
    • PICF update