Chickasaw Nation Industries and ArisGlobal Strengthen Seven Year Partnership to Advance FDA Pharmacovigilance Modernization

Washington D.C, – July 8, 2026 – Chickasaw Nation Industries (CNI) and ArisGlobal, an AI-first technology company at the forefront of life sciences and creator of LifeSphere® , proudly announce the continued progress in supporting the U.S. Food and Drug Administration’s (FDA) mission to enhance national Pharmacovigilance capabilities. Over the past seven years, the collaboration has delivered transformative advancements that strengthen public health protections and modernize the FDA’s Adverse Event reporting ecosystem.

Together, CNI and ArisGlobal have implemented innovative commercial‑off‑the‑shelf (COTS) and custom-built solutions that significantly improve the FDA’s ability to intake, process, analyze, and share safety data across drugs, biologics, vaccines, cosmetics, tissues, and human cell products. This long-standing partnership has resulted in a rapidly evolving, AI‑enabled enterprise platform that now supports both pre‑market and post‑market safety reporting.

Key achievements, include:

• Modernization of the FDA’s Adverse Event Reporting Infrastructure: In September 2021, the FDA launched the modernized FAERS II platform—now the Adverse Event Monitoring System (AEMS)—leveraging LifeSphere Multivigilance and Intake & Triage to support harmonized adverse event intake, case management, workflow orchestration, and regulatory reporting across multiple FDA product and safety domains in close collaboration with CNI. This effort included a successful transition of FAERS capabilities to the AWS Cloud, enabling faster processing, improved scalability, and stronger security controls.
• Expansion of Safety Case Intake Capabilities Across Multiple Product Domains: From 2024 through 2026, CNI and ArisGlobal helped the FDA deliver multiple new intake capabilities. These expansions represent major milestones toward a unified, enterprise‑wide intake platform.
  • R3 post‑market case intake (January 2024)
  • Premarket R3 ingestion readiness to support industry validations (March 2024)
  • Product Quality case intake capabilities (June 2024)
  • Cosmetics case intake—electronic and paper—plus dashboarding for public data sharing (December 2024 – June 2025)
  • Vaccine and CVM Food adverse event case intake capabilities (2025–2026)
• Significant Enhancements to FDA Data Quality, Reporting, and Public Transparency: CNI and ArisGlobal have delivered ongoing improvements to FDA’s MedWatch forms and unified the FDA Product Dictionary—integrating reporting requirements across multiple centers. In 2025, the team automated refresh mechanisms for the FAERS Public Dashboard, marking the first time these critical datasets were shared daily with the general public.

Building on this foundation, CNI and ArisGlobal continue collaborating with FDA domain experts and technology teams to expand the AEMS platform into a fully unified, agency‑wide Pharmacovigilance system. Planned enhancements include extending intake capabilities to medical devices, veterinary products and veterinary drugs, and human food safety cases. These improvements will enable more comprehensive adverse event monitoring, streamline data integration across FDA Centers, and further advance the agency’s mission to protect public health.

 “The partnership between CNI’s development team and the ArisGlobal product team reflects a strong collaborative effort in support of the FDA’s pharmacovigilance modernization initiatives,” said Pranav Jaidka, Program Director at CNI. “Our teams work side-by-side, often under tight regulatory timelines, to rapidly deliver FDA-specific requirements that meet both industry expectations and public health needs. This shared commitment to innovation, quality, and mission execution continues to drive the success of our collaboration and the advancement of the FDA’s pharmacovigilance capabilities.”

“Modernizing pharmacovigilance infrastructure at this scale requires deep collaboration, regulatory understanding, and technology designed for long-term evolution,” said Rupesh Bajpai, Senior Director, Customer Excellence, ArisGlobal. “Together with CNI, we have helped establish a more unified and scalable foundation for adverse event monitoring that supports the FDA’s broader public health mission and long-term modernization objectives.”

About Chickasaw Nation Industries

Chickasaw Nation Industries, Inc. (CNI), operating through its government contracting arm Chickasaw Federal, is one of the largest tribally owned federal contractors in the United States. With over 30 years of experience, CNI delivers enterprise technology solutions—including cloud implementation, cybersecurity, and data science—designed to drive federal agency missions forward. Every solution reflects a commitment to innovation and service, delivering impactful results for government partners while promoting the economic development and long-term viability of the Chickasaw Nation. For more information, visit https://chickasawfederal.com/ or follow CNI on LinkedIn at https://www.linkedin.com/company/705595/.

About ArisGlobal
ArisGlobal, an innovative life sciences technology company and creator of LifeSphere®, is transforming how today’s most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on https://www.linkedin.com/company/aris-global/. http://www.arisglobal.com/.