Affordable, cloud-based SaaS solution automates E2B (R2) to E2B (R3) conversion for small and mid-size pharma organizations

ROCKVILLE, Md.: CTIS, Inc., with more than 30 years of experience in Health IT and clinical research informatics expertise for government and industry clients, today announced the commercial availability of Trial SafetyXchange. The cloud-based software-as-a-service (SaaS) solution is purpose-built to help small and mid-size pharmaceutical companies, biotech firms, and contract research organizations (CROs) seamlessly convert Individual Case Safety Report (ICSR) files from the prior E2B (R2) format to the U.S. Food and Drug Administration (FDA)-mandated E2B (R3) standard ahead of the agency’s April 1, 2026 compliance deadline.

Trial SafetyXchange addresses a critical gap in the pharmacovigilance technology market. With the April deadline approaching, organizations that have not yet transitioned to E2B (R3) face potential regulatory consequences and penalties imposed by the FDA. For companies without an existing enterprise solution, Trial SafetyXchange offers a practical, immediately deployable path to compliance-at a fraction of the cost and human resource drain of traditional platforms.

“Creating E2B R3 outputs from the ground up is highly complex and requires specialized expertise-it’s not realistically achievable without the right technology, especially in light of the FDA’s E2B R3 mandate,” said Vaibhav Kothale, vice president and chief program and projects officer at CTIS. “With Trial SafetyXchange, we’re enabling companies to meet the FDA mandate without investing in expensive enterprise systems. Our solution removes barriers to compliance by simplifying the ICSR format conversion process and significantly reducing its associated costs.”

Trial SafetyXchange was designed with ease of use in mind. The solution accepts existing E2B (R2) files, automatically converts them to the R3 format, and runs them through a robust built-in validation engine-all through a 100% web-based interface that requires no downloads, no IT infrastructure, and no prior technical training. Organizations can be up and running quickly and submit reports with confidence, knowing their files comply with both the ICH E2B(R3) Implementation Guide and the FDA’s Regional Implementation Guide.

"For more than 30 years, CTIS has been committed to making Health IT solutions that are both powerful and accessible. With Trial SafetyXchange, we're bringing the same depth of expertise we've built supporting the NIH and other federal agencies directly to small and emerging pharma companies that need it most,” said Bharti Shah, CEO and chairwoman of CTIS. “No organization should face a compliance deadline without a viable path forward simply because they lack the budget of a large enterprise. We’re proud to make Trial SafetyXchange available to the broader clinical research community."

Trial SafetyXchange is available now. Organizations interested in learning more or scheduling a demo can visit www.trialsafetyxchange.com or contact the CTIS sales team at sales@trialsafetyxchange.com or 240-499-2200.

Take advantage of our Exclusive Launch Offer with complimentary access, available for a limited time.

About CTIS, Inc.

CTIS, Inc. is a Women-Owned Small Business (WOSB) headquartered in Rockville, Maryland, with more than 30 years of experience delivering Health IT solutions in support of clinical trials, hospitals, and research institutions. A trusted government contractor with a strong track record supporting federal agencies including the National Institutes of Health (NIH), CTIS specializes in clinical research informatics, safety reporting and monitoring, health data standards, and privacy and security solutions. The company is committed to creating secure, user-centered systems that reduce costs, accelerate drug development, and improve patient care. Learn more at www.ctisinc.com.

Fonte: Business Wire