The Importance of Pharmacovigilance

Pharmacovigilance is a critical aspect of drug development and post-market surveillance. We have a deep understanding of the necessity of staying up to date on safety concerns and regulatory requirements. 

ECNE Research offers comprehensive pharmacovigilance services to ensure product safety and regulatory compliance throughout the product lifecycle. Our services include safety signal detection and management, adverse event reporting, case management, the preparation of aggregate safety reports such as PSURs, DSURs, and PBRERs. We also develop and maintain risk management plans to proactively address product risks, helping our clients navigate complex safety regulations with confidence and prioritize patient safety.

We also support medical literature monitoring. Our literature reviews are meticulously conducted to provide you with timely literature reports to support your pharmacovigilance requirements. 

PSURs and DSURs: The guardians of drug safety, ensuring patient well-being throughout a drug's journey.

These crucial pharmacovigilance reports act like watchdogs, monitoring safety at every stage. PSURs keep a watchful eye on medications once they reach the market, identifying any new risks. Meanwhile, DSURs diligently track safety concerns during development.

Both PSURs and DSURs are mandatory for regulatory compliance. They play a vital role in ensuring the benefits of a drug outweigh the risks for patients. By providing a comprehensive picture of drug safety, these reports ultimately contribute to the well-being of countless individuals who rely on these medications.