COA

TransPerfect Life Sciences Announces eCOA LingCert Program

Retrieved on: 
Mercoledì, Marzo 1, 2023
Clinical trial, Clinical, Clario Tech, Tablet, United States Department of the Army, Patient, COA, Silver, Certification, American Opportunity Tax Credit, TransPerfect, EVP, Nursing, Platinum, Gold

NEW YORK, March 1, 2023 /PRNewswire/ -- TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced the rollout of its certification solution for accrediting electronic clinical outcome assessment (eCOA) technology platforms based on their ability to host eCOA localized materials according to industry standards, best practices, and sponsor needs.

Key Points: 
  • The solution, called eCOA LingCert, has three certification levels: Silver, Gold, and Platinum.
  • With this certification, eCOA platforms are also well-positioned to reduce translation costs and enhance overall eCOA quality by aligning with and meeting sponsor expectations.
  • TransPerfect President and CEO Phil Shawe stated, "We're excited to now offer the eCOA LingCert accreditation program.
  • This certification gives our life sciences clients and partners a standardized approach to hosting localized eCOA materials."

TransPerfect Life Sciences Announces eCOA LingCert Program

Retrieved on: 
Mercoledì, Marzo 1, 2023
Health, Technology, Health Technology, Software, Clinical Trials, Biotechnology, Certification, Clinical trial, Clinical, Clario Tech, Silver, TransPerfect, American Opportunity Tax Credit, EVP, United States Department of the Army, COA, Nursing, Platinum, Gold

TransPerfect Life Sciences , a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced the rollout of its certification solution for accrediting electronic clinical outcome assessment (eCOA) technology platforms based on their ability to host eCOA localized materials according to industry standards, best practices, and sponsor needs.

Key Points: 
  • TransPerfect Life Sciences , a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced the rollout of its certification solution for accrediting electronic clinical outcome assessment (eCOA) technology platforms based on their ability to host eCOA localized materials according to industry standards, best practices, and sponsor needs.
  • The solution, called eCOA LingCert, has three certification levels: Silver, Gold, and Platinum.
  • With this certification, eCOA platforms are also well-positioned to reduce translation costs and enhance overall eCOA quality by aligning with and meeting sponsor expectations.
  • This certification gives our life sciences clients and partners a standardized approach to hosting localized eCOA materials.”

American Water’s Unmanned Aerial System Program Enters into Partnership with The New Jersey Innovation Institute

Retrieved on: 
Venerdì, Gennaio 27, 2023
Professional Services, Utilities, Environment, Environmental Issues, Energy, Finance, Banking, Unmanned aerial vehicle, American Water Works, Altitude, Water, COA, NYSE, UAS, American Water, NJIT, Research, Atmosphere, New Jersey Institute of Technology, Government, FAA

American Water (NYSE: AWK), the largest publicly traded U.S. water and wastewater utility company, announced today its Unmanned Aerial System (UAS) Program has entered into an agreement with The New Jersey Innovation Institute (NJII), an New Jersey Institute of Technology (NJIT) corporation, to perform research under a NJIT Federal Aviation Administration (FAA) Part 91 Certificate of Authorization (COA).

Key Points: 
  • American Water (NYSE: AWK), the largest publicly traded U.S. water and wastewater utility company, announced today its Unmanned Aerial System (UAS) Program has entered into an agreement with The New Jersey Innovation Institute (NJII), an New Jersey Institute of Technology (NJIT) corporation, to perform research under a NJIT Federal Aviation Administration (FAA) Part 91 Certificate of Authorization (COA).
  • The COA enables research activities to take place both beyond visual line of sight (BVLOS) and up to an altitude of 1,500 feet above ground level.
  • “Through American Water's leadership, our country is another step closer to making safe BVLOS drone missions commonplace.
  • This press release is an update to an announcement previously distributed by American Water on January 24, 2023.

Cepheid Receives Emergency Use Authorization from FDA for Xpert® Mpox

Retrieved on: 
Martedì, Febbraio 14, 2023
World Health Organization, Certificate, Monkeypox virus, Cepheid (company), COC, EVP, PCR, Diagnosis, Cor, Measles, POC, Simplex, Human, Cedillo v. Secretary of Health and Human Services, Syphilis, Infection, Chickenpox, Cow, Fever, EUA, COA, Medical device, Vaccine, Xpert, Cepheid variable

SUNNYVALE, Calif., Feb. 14, 2023 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration for Xpert Mpox, which runs on Cepheid's GeneXpert® systems. The EUA is supported by the Secretary of Health and Human Service's declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox virus.

Key Points: 
  • SUNNYVALE, Calif., Feb. 14, 2023 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration for Xpert Mpox, which runs on Cepheid's GeneXpert® systems.
  • Xpert Mpox is authorized for use in moderately complex settings and is considered authorized for use in point of care (POC) settings under the EUA for use on GeneXpert Xpress systems.
  • "Thankfully, the threat of mpox in the United States has decreased dramatically since last summer.
  • The World Health Organization recommends that suspected cases of mpox be confirmed with a PCR test run on an appropriate human lesion sample1.

Clinical Outcome Assessments (COA): Diving Deeper, Applying Scientific Rigor and Good Instrument Design, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Martedì, Gennaio 31, 2023
Science, Data collection, Behavioral Science Consultation Team, COA, Collection, Doctor of Philosophy, Medical device, Medical imaging, Clario Tech

TORONTO, Ontario, Jan. 31, 2023 /PRNewswire-PRWeb/ -- The bedrock of a successful trial is a well-designed protocol with reliable measurements of biomedical and health-related outcomes to satisfy regulatory standards. There is a knowledge gap between the field of clinical trials and other relevant scientific disciplines on fundamental methodological principles that should govern the collection of clinical outcome assessments (COA) data. This webinar takes a deep dive into how scientific rigor can be applied to COA even though they are subjective. The featured speakers will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges.

Key Points: 
  • In this free webinar, learn how scientific rigor can be applied to clinical outcome assessments (COA) even though they are subjective.
  • This webinar takes a deep dive into how scientific rigor can be applied to COA even though they are subjective.
  • The featured speakers will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges.
  • Join this webinar to learn more about applying scientific rigor and good instrument design to clinical outcome assessments.

Charlotte's Web Issues Statement on Hemp CBD Regulation

Retrieved on: 
Venerdì, Gennaio 27, 2023
Institutional review board, Veteran, Safety, Athlete, Economy, CWEB, Congress, Charlotte's Web, News, Good laboratory practice, COA, Peer review, PubMed, Organization, TSX, Sale, FDA, Cannabidiol, Gold, Toxicology, OECD, Azerbaijan and Organization for Economic Co-operation, Administration, NSF, Dietary supplement, CBD

DENVER, Jan. 27, 2023 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF) Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company"), the market leader in cannabidiol ("CBD") hemp extract wellness products issues the following statement regarding the FDA's January 26th press announcement:

Key Points: 
  • DENVER, Jan. 27, 2023 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF) Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company"), the market leader in cannabidiol ("CBD") hemp extract wellness products issues the following statement regarding the FDA's January 26th press announcement:
    Charlotte's Web is encouraged that the Administration has agreed that it is necessary for Congress to act for the regulation of hemp-derived cannabidiol ("CBD").
  • As the CBD pioneer and market leader, Charlotte's Web has engaged in safety studies and compiled toxicology data including liver safety.
  • During this four-year period of regulatory absence, Charlotte's Web has set the standard in responsible self-regulation in product manufacturing, safety, and labeling.
  • Recently, Charlotte's Web became the first and only broad-spectrum CBD hemp extract to be NSF Certified for Sport®, the gold standard to ensure safe and consistent products for professional athletes and consumers alike.

MightyFly Unveils Its Second-Generation eVTOL for Up to 600 Miles of Same-Day, Door-to-Door Delivery

Retrieved on: 
Martedì, Gennaio 24, 2023
Aircraft, Takeoff, Carbon, Atmosphere, Airworthiness certificate, United, USPS, COA, FAA, SAN, Federal Aviation Administration, Cento, SBIR, Airline, Transport, Warehouse

With eight electric vertical lift fans, one forward propulsion propeller, and a high wing carbon fiber airframe, the fully loaded Cento weighs just 355 pounds (161 kg).

Key Points: 
  • With eight electric vertical lift fans, one forward propulsion propeller, and a high wing carbon fiber airframe, the fully loaded Cento weighs just 355 pounds (161 kg).
  • It measures 13.1 ft by 16.7 ft (4 m by 5 m) taking up a total area that is less than two compact cars.
  • An internal combustion engine recharges the aircraft's battery while in the air, enabling it to perform multiple consecutive deliveries.
  • The Federal Aviation Administration (FAA) has granted the MightyFly Cento a Special Airworthiness Certificate and a Certificate of Authorization (COA) for long-range flights.

FREYR Battery Signs First E-Mobility Offtake Agreement with Impact Clean Power Technology to Supply Up to 14 GWh of LFP Cells

Retrieved on: 
Giovedì, Gennaio 12, 2023
Batteries, Alternative Energy, Energy, Technology, Environment, Other Transport, Green Technology, Packaging, Rail, Transport, Manufacturing, Telecommunications, Transport, Cell, Entrepreneurship, Battery, LFP, NYSE, Telecommunication, Carbon, Kilowatt-hour, COA, Paris, Traction, ESS, Renewable energy, Impact

FREYR Battery (NYSE: FREY) (“FREYR”), a developer of clean, next-generation battery cell production capacity, has announced a conditional offtake agreement (“COA”) with Impact Clean Power Technology (“Impact”), a leading manufacturer of battery systems for transportation, industry and stationary energy storage for renewable energy sources, traditional power generation, rail, and telecommunications.

Key Points: 
  • FREYR Battery (NYSE: FREY) (“FREYR”), a developer of clean, next-generation battery cell production capacity, has announced a conditional offtake agreement (“COA”) with Impact Clean Power Technology (“Impact”), a leading manufacturer of battery systems for transportation, industry and stationary energy storage for renewable energy sources, traditional power generation, rail, and telecommunications.
  • Under the terms of the agreement, FREYR will supply 10 – 14 GWh of clean, next-generation battery cells based on the 24M Technologies, Inc. (“24M”) SemiSolidTM platform to Impact from 2025 – 2030.
  • FREYR intends to supply Impact with clean battery solutions based on the same battery cell architecture as the ESS products that will be produced at its Giga Arctic battery production facility in Mo i Rana, Norway.
  • The LFP cells will be integrated into Impact’s E-Mobility products for use in commercial vehicles as well as other applications.

New Partnership Uses Blockchain to Advance Credibility and Quality in Legal Cannabis, CBD Industries

Retrieved on: 
Martedì, Gennaio 10, 2023
Partnership, Digital, COA, Cannabinoid, Cryptocurrency, Covalent bond, CBD

For both companies, the partnership is a crucial step forward in achieving increased visibility in the legalized cannabis, CBD and hemp industries.

Key Points: 
  • For both companies, the partnership is a crucial step forward in achieving increased visibility in the legalized cannabis, CBD and hemp industries.
  • Covalent President and Founder Kelly Ann Bortman is enthusiastic about how this partnership will impact the industry.
  • “We want to thank Qredible for coming to the marketplace with a verification process that will standardize the industry as a whole, from CBD to nutraceuticals,” Bortman said.
  • "It's critical that all companies touching consumables, including all CBD, hemp and cannabis businesses, have access to this platform," said Bortman.

In NCLA Amicus Win, Ohio Supreme Court Rejects Deference to Agency Interpretations

Retrieved on: 
Martedì, Gennaio 3, 2023
Government, Justice, W-2, Judgement, Supreme court, NCLA, Court, Supreme Court of the United Kingdom, Law of the United Kingdom, Appeal, Jurisprudence, S. D. Warren Co. v. Maine Board of Environmental Protection, COA, Ohio Board of Regents, Language, Engineering, State supreme court, Private investigator, Property management, Practice of law

Washington, D.C., Jan. 03, 2023 (GLOBE NEWSWIRE) -- The Supreme Court of Ohio, in a 4-3 opinion , denounced agency deference and ruled that the state’s courts need not defer to agency interpretations of ambiguous statutes.

Key Points: 
  • Washington, D.C., Jan. 03, 2023 (GLOBE NEWSWIRE) -- The Supreme Court of Ohio, in a 4-3 opinion , denounced agency deference and ruled that the state’s courts need not defer to agency interpretations of ambiguous statutes.
  • In line with NCLA’s analysis, the Supreme Court of Ohio held that mandatory agency deference violates separation-of-powers principles and strips courts of the judicial authority “to say what the law is.” Citing NCLA founder and CEO Philip Hamburger’s scholarship, the Court also highlighted how agency deference results in systematically biased judgments in cases where a government agency is also a party.
  • NCLA commends the Supreme Court of Ohio for ruling that courts, not government agencies, have the final say over ambiguous laws.
  • NCLA applauds the Court for clarifying Ohio’s deference jurisprudence and joining the increasing number of courts in other states who have similarly rejected deference and declined to cede judicial authority to executive agencies.”