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

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2 months ago

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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.

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Felicitysolar Strengthens Brand Presence at SNEC 2026

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June 20, 2026

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GUANGZHOU, China, June 20 2026 /PRNewswire/ — Felicitysolar presented its energy storage product portfolio, technical progress, third-party recognition, and global cooperation achievements at SNEC 2026, held in Shanghai from June 3 to June 5.

During the exhibition, Felicitysolar showcased solutions for residential, commercial, and industrial energy applications, including the 50kW C&I ESS, 125kW/257kWh system, 125kW/261kWh liquid-cooled all-in-one system, and FLB Series low-voltage residential battery pack. These products reflected the company’s continued focus on system reliability, flexible deployment, and practical energy storage needs across different scenarios.

Felicitysolar also held Chinese and English product presentations on June 3 and June 4, covering commercial and industrial energy storage systems, low-voltage residential battery packs, intelligent management platforms, and the company’s newly developed AI management platform. Through application-oriented explanations, the presentations helped customers better understand the role of Felicitysolar’s products in residential, commercial, and industrial energy management.

Third-party activities during the exhibition added further depth to Felicitysolar’s brand presentation. Intertek issued ETL certificates for Felicitysolar’s energy storage system and photovoltaic inverter products and granted the company Intertek “Satellite Program” laboratory qualification, supporting product access to the North American market and recognizing Felicitysolar’s in-house testing capability. DEKRA presented certificates related to Felicitysolar’s hybrid inverter and energy storage battery system products for European and international standards. SGS granted an Australian grid-connection certificate for Felicitysolar’s IVGM25KHP3G3 Series high-voltage hybrid inverter. EUPD Research recognition was also presented during the exhibition.

In addition, Felicitysolar received three Global Smart Energy Award honors: ENTERPRISE OF THE YEAR, FRONTIER TECHNOLOGY, and INNOVATIVE SOLUTION. These awards recognized Felicitysolar’s overall development, the FLB Series low-voltage LiFePO4 battery pack, and the 50kW high-voltage hybrid energy storage system, respectively. Together with the third-party activities, the awards highlighted Felicitysolar’s continued progress in product development, quality systems, market readiness, and solution capabilities.

The company also held partner signing ceremonies for Argentina and Chile, strengthening communication and cooperation with partners in Latin America. As energy storage demand grows across regional markets, localized cooperation remains an important part of Felicitysolar’s global development.

To extend the exhibition experience beyond the venue, Felicitysolar launched an online VR booth tour, allowing customers to explore the booth layout, featured products, and related materials after the event:
https://www.felicitysolar.com/snec-pv-power-expo-shanghai-vr-tour/

Through product showcases, technical presentations, third-party activities, award recognition, localized partnerships, and digital exhibition tools, Felicitysolar used SNEC 2026 to present its brand capabilities in solar energy storage. The company will continue to focus on practical energy needs across residential, commercial, and industrial applications while strengthening its products, services, and global cooperation capabilities.

About Felicitysolar

Founded in 2007 and headquartered in Guangzhou, China, Felicitysolar provides solar energy storage solutions for residential, commercial, and industrial applications. Its product portfolio covers solar inverters, lithium battery packs, integrated solar street lights, commercial and industrial energy storage systems, and related smart energy solutions.

CONTACT:
Felicitysolar Marketing Department
pr@felicitysolar.com
+86-18620102298

View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/felicitysolar-strengthens-brand-presence-at-snec-2026-302805745.html

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Alcott HR Appoints Michael Pascucci as Director of Strategic Projects

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4 hours ago

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June 20, 2026

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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

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Alcott HR Appoints Michael Pascucci as Director of Strategic Projects

Published

4 hours ago

on

June 20, 2026

By

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

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