Why Adverse Event Reporting is Critical in Drug Safety

Adverse event (AE) reporting plays a pivotal role in ensuring patient safety throughout the lifecycle of a pharmaceutical product, from early-stage clinical trials to post-market surveillance. Efficient and timely reporting of adverse events helps identify potential risks, improves patient outcomes, and ensures compliance with global regulatory standards.

At Viltis, we provide comprehensive adverse event reporting services tailored to both clinical trial and post-market needs:

1. Adverse Event Reporting During Clinical Trials: During clinical development, it is critical to capture and report all adverse events (AEs) to regulatory authorities like the FDA and EMA. Adverse events in clinical trials can provide early warnings about potential safety issues, allowing manufacturers to mitigate risks before commercialization.

2. Post-Market Adverse Event Reporting: After a product is approved and enters the market, post-market surveillance ensures ongoing monitoring of drug safety. Real-world data often reveals adverse events not observed in clinical trials due to larger populations and diverse use cases. Our post-market AE reporting services help identify and mitigate risks to maintain patient safety and comply with global regulations.

Why Timely AE Reporting Matters

Delays or inaccuracies in adverse event reporting can result in serious regulatory consequences, including fines, product recalls, or even market withdrawal. Beyond regulatory implications, timely AE reporting ensures patient safety, as early detection of safety signals allows for prompt corrective actions.

How Viltis Supports AE Reporting Compliance

• Real-Time Data Collection: We streamline adverse event reporting with efficient, real-time data collection tools, ensuring that safety data from clinical trials or the market is reported promptly. We also integrate with platforms like MedMind to enhance digital adverse event capture and provide intelligent alerts for faster safety signal detection.

• Global Compliance Expertise: Our pharmacovigilance experts are proficient in navigating the complex web of global regulations, ensuring AE reports are submitted to the relevant regulatory bodies (FDA, EMA, PMDA, etc.).

At Viltis, we help ensure adverse event reporting is not just a regulatory checkbox but a vital process for ensuring patient safety and maintaining your product’s credibility in the market.