PHARMACOVIGILANCE

There is no successful medicine without a thorough pharmacovigilance process during clinical trial phases. It is also unlikely that drugs are safe and effective after being on the market without the ongoing process of pharmacovigilance.

Pharmacovigilance is concerned with the detection, assessment and prevention of adverse

reactions to drugs. Some of the major aims of pharmacovigilance are early detection of adverse reaction hitherto unknown, detection of increases in frequency of known adverse reactions and estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to improve drug prescribing and regulation.

 Continuing monitoring of medicine safety profile is important basically because clinical trials involve a specific group of patients during a certain period of time and conditions, therefore other adverse reactions can be experienced when the drug is available to the whole population after released to market.  

 We are qualified and prepared to develop a comprehensive plan to help you manage your clinical trial and post marketed product safety program. Our services include:

•  Investigative site training;

•  Adverse event and serious adverse event case processing and tracking;

•  Medical review and SAE Narrative writing;

•  Regulatory Reporting Assessment;

•  MeDRA coding;

•  SAE Reconciliation;

•  ANVISA and CVS case submission;

•  Safety database entry and generation of CIOMSI and MedWatch forms generation.