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CTIS Launches Trial SafetyXchange for FDA Compliance
New platform aims to help pharmaceutical companies meet E2B(R3) reporting deadline.
Apr. 2, 2026 at 3:48pm
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CTIS, Inc., a leading provider of clinical trial management solutions, has launched a new platform called Trial SafetyXchange to help pharmaceutical companies meet the critical FDA E2B(R3) compliance deadline. The E2B(R3) standard is a new global format for reporting adverse events in clinical trials, and companies must be compliant by the end of the year.
Why it matters
The E2B(R3) standard is a major regulatory change that requires pharmaceutical companies to overhaul their systems and processes for reporting adverse events in clinical trials. Failure to comply could result in significant penalties and delays. CTIS's new platform is designed to simplify the transition and ensure companies can meet the deadline.
The details
Trial SafetyXchange is a cloud-based platform that automates the conversion of adverse event data into the E2B(R3) format. It integrates with existing clinical trial management systems and provides tools for data mapping, validation, and submission. The platform also offers training and support to help companies navigate the new requirements.
- The FDA E2B(R3) compliance deadline is set for the end of 2026.
The players
CTIS, Inc.
A leading provider of clinical trial management solutions.
What’s next
Pharmaceutical companies must act quickly to ensure they are E2B(R3) compliant before the end-of-year deadline.
The takeaway
The launch of Trial SafetyXchange highlights the critical importance of the E2B(R3) standard and the need for pharmaceutical companies to modernize their clinical trial reporting systems to avoid regulatory issues and delays.
