Safety Solutions

· SafetyNET™

· (ES2)

CDISC Standards

Products : HPR : SS : Adverse Events Reporting

Adverse Events Reporting

An escalation in the number of adverse events reported to regulators and announced to the general population in recent years has created a need for automated adverse event tracking and reporting tools in biopharmaceutical organizations of all types and sizes. Accurate, timely and complete data about adverse events are critical to preventing safety problems and helping manage public perceptions.

Regulatory requirements in the pharmacovigilance area include tight deadlines for reporting the most serious cases as well as complex ongoing requirements for reporting, tracking and analyzing all adverse events and incidents that occur. As regulators move toward requiring electronic submission of case reports, technology that manages the collection, coding, reporting and analysis of safety data has become critical.

AER Solution: SafetyNET™

MedChannels’ SafetyNET product has been helping pharmaceutical, biotech and medical device companies identify, analyze and report adverse events, as well as meet regulatory reporting deadlines and global requirements. This Web-based product links all safety personnel electronically, which helps to speed information delivery, prevent delays, and provide visibility into work-in-process and due dates. The latest version of the product, SafetyNET 3.1, features a single authoring environment for creating reports to improve decision-making and increase business agility. The SafetyNET 3.1 application is also consistent with the FDA’s recent MedWatch 3500A changes.

The SafetyNET 3.1 product integrates with MedChannels' Electronic Study Submissions Module (ES2), automating the exchange of electronic case safety information with regulatory agencies, affiliates and trading partners. Report status information, like submission and recipient acknowledgement, is visible in the SafetyNET environment.

Clinical Data Solutions

Safety Solutions

CDISC Standards

Adverse Events Reporting

AER Solution: SafetyNET™