June 24, 2026

CTIS, Inc., a Women-Owned Small Business (WOSB) headquartered in Rockville, Maryland, today announced its selection as a 2026 WTOP News Top Workplace. The designation is based entirely on confidential results from the independent Energage Workplace Survey, a research-backed assessment of employee engagement, leadership quality, and organizational culture. The recognition reflects the workforce stability and employee engagement that have sustained CTIS’s federal health IT delivery at the National Institutes of Health (NIH) for nearly four decades.

“This recognition carries weight because it comes from the people who do the work, our clinical informaticists, data engineers, and health IT specialists who support NIH programs every day,” said Bharti Shah, CEO of CTIS, Inc. “When employees stay, they build the kind of institutional knowledge and domain depth that you cannot replicate through hiring alone. That continuity is what allows us to deliver consistently across contract cycles, and it is why we are investing in AI-native training and professional development, so our teams are equipped for the next generation of federal health challenges, not just today’s.”

CTIS has maintained a 93.7% employee retention rate across its active federal health IT programs. On its longest-running engagement, NCI’s Cancer Therapy Evaluation Program Enterprise System (CTEP-ESYS), a clinical research informatics platform CTIS originally developed in 1996, more than 30 team members have served continuously for over a decade.

The company delivers through GSA MAS, CIO-SP3 Small Business, and SPARC-SB contract vehicles, providing federal agencies with established procurement pathways for health IT modernization and AI-enabled clinical research solutions. CTIS recently earned the SAFe AI-Native Charter Partner designation, reflecting its investment in equipping delivery teams with the frameworks and skills required for responsible AI adoption in regulated federal health environments.

The Energage Workplace Survey, which administered the assessment underlying the WTOP Top Workplaces program, measures the key drivers of employee engagement and organizational health, including how employees experience leadership, support, growth opportunities, and their connection to the organization’s mission. For more information on the survey methodology, visit energage.com or topworkplaces.com.

April 2, 2026

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.

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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.

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Press Contact
Mehul Shah
Modernization & Growth Director, CTIS, Inc.
Phone: 301-948-3033 x2143
Email: mhshah@ctisinc.com
Website: www.ctisinc.com | www.trialsafetyxchange.com

Exciting News! Our work at CTIS has been recognized on a national stage! Orange Slices has featured an article on the “Most Noticed in 2023” WOSB list, and CTIS has made the cut! 
It’s a testament to the dedication and hard work of our incredible team. Thank you to everyone who’s been a part of this journey. We look forward to continuing our commitment to excellence and making a difference in the world of WOSB in the years to come.

Read the full article here https://lnkd.in/e3uuYrDX and let’s keep striving for greatness together!

#CTIS #WOSB #Leadership #Recognition #TeamWork #SuccessStory