Technology

Paradigm Health Announces Collaboration with the FDA to Transform Regulatory Review of Clinical Trial Data

Published

2 months ago

April 28, 2026

The initiative will be implemented in two trials, using Paradigm Health’s integrated technology platform to accelerate FDA review

WASHINGTON and COLUMBUS, Ohio, April 28, 2026 /PRNewswire/ — Today, Paradigm Health announced the launch of a landmark research collaboration with the U.S. Food & Drug Administration (FDA) focused on advancing a new model to accelerate clinical trial execution and regulatory review. The new model, already operational in a Phase 2 and Phase 1b trial, uses Paradigm Health’s technology-enabled Study Conduct platform to enable real-time review by the FDA, by automating data collection and analysis, and streamlining the reporting of key safety and efficacy signals to trial sponsors and the FDA. The goal is to establish a scalable model that reduces monitoring burden, data entry, and trial costs—speeding regulatory review, improving U.S. clinical trial efficiency, and accelerating cures to patients.

Pharmaceutical companies Amgen and AstraZeneca are the first to join the collaboration. The new model has launched in an AstraZeneca-sponsored Phase 2 trial at sites including MD Anderson Cancer Center and Perelman School of Medicine at the University of Pennsylvania, as well as an Amgen-sponsored Phase 1b trial.

The Paradigm Health Study Conduct solution works by capturing data directly from electronic health records and other structured and unstructured sources, algorithmically evaluating FDA-defined data points and reporting criteria in real time, and transmitting only the critical signals and data needed for regulatory determinations to the trial sponsor and the FDA. Paradigm Health has engineered this infrastructure specifically for the collaboration, working closely with the FDA since early 2026 to define reporting and validation protocols, establish criteria for key regulatory events, and ensure FDA-Paradigm Health software and data interoperability. The data transferred through the real-time platform is traceable, auditable, and protects patient privacy, while minimizing the transfer of unnecessary datasets.

“This collaboration represents an important step toward expediting how clinical trial data is submitted to and reviewed by the FDA,” said Kent Thoelke, Founder and CEO of Paradigm Health. “With Paradigm Health’s platform, clinical trial data can be analyzed for key signals in near real time and shared with trial sponsors and the FDA in days, rather than months. This means that regulators, sponsors, and providers can have a continuous view of safety and efficacy. By modernizing the flow of information from sites to sponsors to regulators, we have an opportunity to accelerate the delivery of innovative therapies to patients across the country.”

“The initiative leverages the best of U.S. technology and innovation to bolster clinical development in the United States,” said Robert Nelsen, Co-Founder and Managing Director of ARCH Venture Partners and Paradigm Health Co-Founder and Board Chair. “This model can align the interests of policymakers, pharmaceutical and biotech companies, and American patients, and make U.S. clinical research faster and more cost-effective.”

Building the Future of U.S. Clinical Trials

The need for modernization in clinical development is urgent, as innovation in U.S. clinical trial infrastructure has not kept pace with the volume of therapeutic candidates under investigation. Trials are long, complex, and expensive. This collaborative model, if deployed successfully and at scale, can help bring new medicines to American patients faster. Furthermore, efficient, less expensive trials make the United States a more compelling and competitive place for innovative companies to conduct research.

This collaboration directly supports the FDA’s strategic goal of moving toward a real-time, continuous regulatory environment, and underscores Paradigm Health’s commitment to modernizing drug development infrastructure and expanding access to cutting-edge clinical research regardless of where patients live.

About Paradigm Health

Paradigm Health has engineered an AI-powered platform to make clinical trials more accessible and efficient, so that patients, researchers, and study sponsors can maximize the impact of clinical research. Incubated by ARCH Venture Partners and backed by leading healthcare and life sciences investors, Paradigm Health aims to break down barriers across the trial ecosystem through one seamless infrastructure implemented at healthcare provider organizations, bringing potentially life-saving therapies to patients faster. For more information, visit https://www.paradigmhealth.ai.

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SOURCE Paradigm Health, Inc.

Technology

Alcott HR Appoints Michael Pascucci as Director of Strategic Projects

Published

2 hours ago

June 20, 2026

FARMINGDALE, N.Y., June 19, 2026 /PRNewswire/ — Alcott HR announces Michael Pascucci as Director of Strategic Projects. Michael brings over ten years of experience in HR operations and project management.

Before joining Alcott HR, he held senior roles leading technology upgrades and launching new employee benefits programs. This experience supports Alcott’s initiatives, helping the company grow while putting clients first.

As Director, Michael drives operational excellence at Alcott HR by leading strategic projects. He maintains processes to ensure Alcott stays flexible and personalized during growth. Michael focuses on projects that further enhance client support.

Improving Data Accuracy: Michael connects Alcott’s main systems with partners. Automating these connections streamlines onboarding and enrollment, ensuring benefits and payroll are accurate and secure. This gives clients confidence their information is in good hands.

Creating a Seamless Client Experience: Michael is improving how Alcott manages projects and client renewals. With consistency in these processes, Alcott delivers a seamless, dependable experience, especially during year-end reporting and enrollment.

Building for Growth: By replacing manual tasks with digital solutions, Michael helps Alcott grow with its clients. This allows the team to focus on building relationships and offering expert HR guidance to help clients achieve their goals.

“Michael doesn’t just manage projects, he builds systems that help our team excel,” said Kristen Bartolotta, Sr. Director of Operations at Alcott HR. “His ability to transform complex processes into streamlined solutions has improved our efficiency and enhanced our client service.”

“Working with the talented Alcott team has been a great experience,” said Michael Pascucci. “I’m excited to continue working across departments to improve our processes, boost efficiency, and help the company keep growing.”

Through these efforts, Michael helps Alcott deliver even greater value to clients by driving innovation, strengthening relationships, and ensuring every organization can reach its potential.

About Alcott HR: Alcott HR is an IRS Certified* and ESAC Accredited, Professional Employer Organization that provides a comprehensive range of human resources solutions to small and mid-sized businesses. With nearly four decades of experience, Alcott HR offers customized services that allow businesses to manage their workforce more effectively while staying compliant with state and federal regulations. Their services include payroll, benefits, risk management, and HR support, designed to help businesses grow and succeed.

The IRS does not endorse any particular certified professional employer organization.

Media Contact:
Sarah Zulawski
Marketing Specialist
szulawski@alcotthr.com
(716) 241-8893

View original content to download multimedia:https://www.prnewswire.com/news-releases/alcott-hr-appoints-michael-pascucci-as-director-of-strategic-projects-302805721.html

SOURCE Alcott HR

Technology

Alcott HR Appoints Michael Pascucci as Director of Strategic Projects

Published

2 hours ago

June 20, 2026

Through these efforts, Michael helps Alcott deliver even greater value to clients by driving innovation, strengthening relationships, and ensuring every organization can reach its potential.

The IRS does not endorse any particular certified professional employer organization.

Media Contact:
Sarah Zulawski
Marketing Specialist
szulawski@alcotthr.com
(716) 241-8893

View original content to download multimedia:https://www.prnewswire.com/news-releases/alcott-hr-appoints-michael-pascucci-as-director-of-strategic-projects-302805721.html

SOURCE Alcott HR

Technology

Vaultzy and Miracle University Pilot Demonstrates AI-Powered Document Management for Students. Expansion Planned for California Foster Youth Programs

Published

3 hours ago

June 19, 2026

A successful student pilot demonstrates how secure digital records and AI guidance can help them access education, employment, housing, and life opportunities

SACRAMENTO, Calif., June 19, 2026 /PRNewswire-PRWeb/ — Vaultzy, an AI-powered document management and life assistant platform, today announced the successful completion of a pilot with Miracle University, demonstrating how secure digital records and intelligent guidance can help students overcome barriers to education, employment, and economic mobility.

California State Treasurer Fiona Ma, CPA, noted, “Never expired. Never lost. Your vital documents, all in one secure place.”

For many students, particularly those facing economic hardship or life disruptions, lost identification, unavailable transcripts, and scattered paperwork can delay enrollment, employment, housing applications, financial aid, and access to public services. Vaultzy was created to address this challenge by providing a secure, user-controlled platform for lifelong document management.

Beyond document storage, Vaultzy recently launched the first version of its AI-powered Life Agent. The platform allows users to interact with their personal records and receive guidance related to major life transitions. By understanding what documents a user has available, the Life Agent can help identify requirements and next steps for education, employment, healthcare, government services, financial planning, and other important milestones.

The pilot was conducted in partnership with Miracle University, a Sacramento-based nonprofit organization dedicated to helping students who have left the traditional education system earn their high school diplomas and achieve academic and career success. The initiative focused on helping students digitize, organize, and securely manage their most important records while introducing them to emerging technologies that can support their long-term success.

“Our mission is to help students overcome barriers and unlock their full potential,” said Dr. Kadhir Raja, Founder of Miracle University. “Students need access to their documents, confidence in managing important life transitions, and guidance on what comes next. Vaultzy helps bring all of these together, empowering students to navigate education, employment, housing, and other life opportunities with greater confidence and independence.”

The pilot demonstrated the importance of giving individuals lifelong access to trusted records while providing the tools and guidance needed to use them effectively. As California State Treasurer Fiona Ma, CPA, noted, “Never expired. Never lost. Your vital documents, all in one secure place.”

Looking ahead, Vaultzy plans to continue expanding its AI-powered capabilities. “We envision a future where every individual has a trusted AI companion that not only safeguards their records but also helps guide them through life’s most important transitions,” said Avanti Ramraj, Co-Founder and Chief Product Officer of Vaultzy.

The success of the Miracle University pilot is helping inform broader discussions with educational institutions, nonprofit organizations, financial institutions, and public-sector leaders interested in modernizing how individuals manage and access trusted records while receiving guidance through important life transitions. One of the most promising opportunities is the potential application of Vaultzy within programs serving foster youth, seniors, and other underserved populations.

About Vaultzy

Vaultzy is an AI-powered document management and life assistant platform that helps individuals securely store, manage, and share important records throughout their lives. Combining secure document management, document intelligence, multilingual assistance, and agentic AI capabilities, Vaultzy is building the infrastructure for lifelong document ownership and trusted digital identity.

About Miracle University

Miracle University is a Sacramento-based nonprofit organization dedicated to helping students overcome educational barriers and achieve academic, personal, and professional success. Through mentorship, education, and community support, Miracle University equips students with the skills, confidence, and opportunities needed to transform their futures.

Media Contact
Anupriya Ramraj, Vaultzy, 1 510-255-0657, contact@vaultzy.ai, www.vaultzy.ai

Twitter, LinkedIn

View original content:https://www.prweb.com/releases/vaultzy-and-miracle-university-pilot-demonstrates-ai-powered-document-management-for-students-expansion-planned-for-california-foster-youth-programs-302805103.html

SOURCE Vaultzy