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Loftware and Signant Health Announce Availability of Integrated Clinical Supplies Labeling Solution

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Automates to improve speed, enable compliance, and support scalability

PORTSMOUTH, N.H., Oct. 31, 2024 /PRNewswire/ — Loftware, the global leader in Enterprise Labeling and Artwork Management solutions, and Signant Health, the leader in evidence generation for modern clinical trials, today announced the general availability of their integrated solution. This new offering connects the Loftware Cloud Clinical Trials platform with Signant Health’s GxP Inventory Clinical Supplies Management application.

The new integration supports automation in three key areas. Firstly, it allows clinical trial master data held in GxP Inventory to be transferred into the Loftware Cloud Clinical Trials platform, removing the risk of errors from manual entry processes. Secondly, print requests can be created and approved directly within the GxP Inventory application, thereby improving efficiency and usability. Finally, print status updates are then sent back from Loftware Cloud Clinical Trials to GxP Inventory automatically, ensuring that forward processes in manufacturing can be initiated promptly.

“We’ve seen explosive growth in direct-to-site and direct-to-patient clinical trial supply models, as well as requests for just-in-time packaging to accommodate advanced medicinal products,” said Oliver Cunningham, vice president of supplies management solutions at Signant. “Loftware’s industry-leading labeling capabilities, integrated with our SmartSignals Supplies solution and user workflows, offers customers the agility needed to maximize performance and compliance of their clinical supplies.”

Pharmaceutical companies must scale their clinical supplies management capabilities to address the growing volume and complexity of global clinical trials. Reliance on legacy systems or manual processes introduces the risk of delays, errors, and potential non-compliance with regulatory standards. The close integration between Loftware Cloud Clinical Trials and Signant’s GxP Inventory Clinical Supplies Management application delivers the automation necessary to enhance the efficiency, accuracy, and speed of the end-to-end clinical supplies and labeling process.

Simon Jones, Loftware VP Product Management, Life Sciences, added: “The integration between Loftware Cloud Clinical Trials and Signant ‘s GxP Inventory marks a significant step forward in automating critical aspects of clinical supply chain management. By streamlining data transfer and automating labeling processes, pharmaceutical companies can now accelerate trial timelines, enhance compliance, and reduce risks, all while maintaining the highest levels of accuracy and efficiency.”

Loftware and Signant Health anticipate this as a first release of an evolving product integration intended to support emerging industry best practices. Find out more here.

About Loftware

No matter what the challenge – digital transformation, time to market, or brand authenticity – Loftware can help you make your mark. We understand how global supply chains work and know that each item you produce, and ship is an expression of your company’s brand. We can help you improve accuracy, traceability, and compliance while improving the quality, speed, and efficiency of your labeling. Our end-to-end cloud-based labeling platform helps businesses of all sizes manage labeling across their operations and supply chain and our solutions are used to print over 51 billion labels every year. Loftware also fosters supply chain agility and supports evolving customer and regulatory requirements, helping companies save over $200 million in fines annually. And with over 500 industry experts and 1,000 global partners, Loftware maintains a global presence with offices in the US, UK, Germany, Slovenia, China, and Singapore making us a trusted partner for companies in automotive, chemicals, clinical trials, consumer products, electronics, food & beverage, manufacturing, medical device, pharmaceuticals, retail/apparel, and more.

About Signant Health

Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 25 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, EDC, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at www.signanthealth.com

Media contacts: 

Laura Hindley, Senior PR & Communications Manager, Loftware, lhindley@loftware.com
Heather Bilinski, Senior Director, Corporate Marketing, Signant Health, heather.bilinski@signanthealth.com

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/loftware-and-signant-health-announce-availability-of-integrated-clinical-supplies-labeling-solution-302292752.html

SOURCE Loftware, Inc.

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Macrogen Consortium win tender for National Bio Big Data Project

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Illumina is proud to be selected as sequencing technology partner to the Macrogen Consortium.

SEOUL, South Korea, Dec. 23, 2024 /PRNewswire/ — Macrogen a global healthcare company that specializes in precision medicine and Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, announced today that they are honoured to support the National Bio Big Data project by sequencing and analysing 145,952 Korean genomes.

The National Bio Big Data Project project has been running in Korea as a pilot project since 2020. During this period about 20,000 genomes were analysed, 10,000 of these including people with a rare disease. The ultimate goal is to enable precision medicine by building a reference genome for about 770,000 Koreans by 2028 and a total of 1 million by 2032.  

“Being a part of this step change to improving public health in Korea through the voluntary collection and analysis of genomic, clinical and life record information from the general public, is paramount to ensure precision medicine becomes a standard of care for all Koreans,” said Changhoon Kim, CEO Macrogen.

“Illumina is pleased to be a part of the Korean bio industry ecosystem and to participate in such an important national project. We look forward to contributing to Korea by bringing our expertise and lessons learned from our direct involvement in leading pop gen projects around the world,” said Robert McBride, General Manager of Illumina Korea.

People across the globe have very similar genes but a small number of variants between populations can impact health. For example, some variants are associated closely with particular diseases such as cystic fibrous.[1]These variants can present differently in populations and have a significant impact on how individuals respond to medicines and treatments. Therefore, it is beneficial for Koreans to have information available that is unique to them.

Worldwide, the number of pop gen projects is expanding rapidly, including the UK, Japan, Singapore, Qatar, the United Arab Emirates, and Nigeria.

“Population genome projects are growing worldwide with many programs reaching significant milestones. But despite this inequity remains with the majority of genome datasets being of European descent. This means we have a lot of information how to develop drugs for European populations but this doesn’t translate in any meaningful way to other nationalities, said Robert McBride.

Population genomics provides a platform for industry engagement and investment, specifically in the pharmaceutical, biotechnology, and data sectors. By integrating large, diverse data sets and using advanced computing technology (such as artificial intelligence or machine learning), health systems and partners are optimally positioned to unlock the power of the genome even further, while improving quality of life and care and fostering economic growth.

“Precision medicine is changing how diseases are treated and this benefits everyone. For patients, treatments often work better when decisions are based around an individual’s genome, for drug companies it can reduce cost of development and for governments there are long term savings related to less waste and healthier patients,” said Changhoon Kim.

References

[1] https://www.genome.gov/about-genomics/educational-resources/fact-sheets/human-genomic-variation#:~:text=How%20do%20peoples’%20genomes%20vary,person%20responds%20to%20certain%20medications.

About Macrogen

Macrogen is a global genetic service provider, partnered with over 18,000 scientists in 150+ countries, and with more than 20 years of experience in the industry.

Established in 1997, from the Genome Medical Research Institute of Seoul National University, Macrogen has become a major service provider and consulting agent for government agencies, universities and research institutes around the world.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and connect with us on X (Twitter), Facebook, LinkedIn, Instagram, TikTok, and YouTube

About the Consortium

Macrogen Consortium members include the following companies: DNA Link, Theragen Bio, and CG Invites

View original content to download multimedia:https://www.prnewswire.com/apac/news-releases/macrogen-consortium-win-tender-for-national-bio-big-data-project-302335981.html

SOURCE Illumina

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As 2025 IRS Mileage Rate Hits 70 Cents, Expert Warns: Ditch Risky Apps for Secure Paper Tracking

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Gig economy expert Ed Ryder warns against the risks of mileage tracking apps, and advocates using paper-based tracking methods instead. He introduces The Big Mileage Form, a secure alternative developed over two years to meet the specific needs of food delivery gig workers. Ryder highlights recent tech failures, like the July 2024 global IT outage, to underscore the vulnerabilities of digital solutions. The press release also mentions Ryder’s significant mileage deduction using his form and directs readers to GigCoach.net for additional resources, including a consumer tutorial to drive better food delivery outcomes and a gig coach training program.

PHILADELPHIA, Dec. 22, 2024 /PRNewswire-PRWeb/ — As the IRS announces a standard mileage rate of 70 cents per mile for 2025, gig economy expert Ed Ryder, who has completed over 10,000 deliveries with his own car using major food delivery platforms, urges fellow gig workers to reconsider their mileage tracking methods. While acknowledging the convenience of digital solutions, Ryder advocates for a return to secure, paper-based tracking to protect valuable mileage deductions.

With the mileage rate at 70 cents, accurate tracking is crucial for gig workers and small business owners. Mileage apps seem convenient, but they risk data loss from outages, glitches, and cyber attacks. Many overlook these significant dangers.

“With the mileage rate increasing to 70 cents, accurate tracking is more crucial than ever for gig workers and small business owners,” says Ryder, creator of The Big Mileage Form. “While mileage tracking apps seem convenient, they come with significant risks that many overlook. Network outages, app glitches, and cyber attacks can jeopardize months of data.”

Ryder points to the July 2024 global IT outage as a prime example of technology’s vulnerabilities. “A faulty software update caused mass airline disruptions and impacted other industries, catching major corporations off guard. This incident highlights that even in our digital age, software isn’t infallible. For me, I simply won’t trust mileage tracking apps with my most important tax deduction.”

To address these concerns, Ryder developed a comprehensive, paper-based solution. “I spent two years perfecting The Big Mileage Form, tailoring it to the specific needs of food delivery gig workers,” he explains. “At 11×17 inches, it provides ample space for detailed record-keeping and, crucially, it’s immune to software glitches, data breaches, and ransomware attacks.”

Ryder’s meticulous paper-based record-keeping resulted in a mileage deduction exceeding $19,000 on his 2023 federal taxes. “All my business-related miles are thoroughly documented on paper. I’m fully prepared to defend this deduction in case of an audit. This level of confidence is what I aim to provide other gig workers.”

“In today’s digital age, sometimes the most secure solution is the simplest one,” Ryder concludes. “My form not only ensures data security but also prepares users for potential IRS audits. It’s time to reconsider the old-fashioned, but reliable pen-and-paper method.”

For those interested in learning more about effective mileage tracking and other aspects of gig work, Ryder offers valuable resources on GigCoach.net. These include a tutorial for consumers titled ‘Fair Deal Delivery,’ which provides insights on how to improve food delivery outcomes. Additionally, experienced food delivery couriers can explore Ryder’s gig coach training program. Visit GigCoach.net to access these resources and learn more about The Big Mileage Form.

Media Contact

Ed Ryder, Match Experiment LLC, 1 484-493-8740, hello@ideamaned.com, gigcoach.net

View original content to download multimedia:https://www.prweb.com/releases/as-2025-irs-mileage-rate-hits-70-cents-expert-warns-ditch-risky-apps-for-secure-paper-tracking-302337779.html

SOURCE Gig economy expert Ed Ryder

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DATA BREACH ALERT: Edelson Lechtzin LLP Is Investigating Claims On Behalf Of Ascension Health Customers Whose Data May Have Been Compromised

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NEWTOWN, Pa., Dec. 22, 2024 /PRNewswire/ — The law firm of Edelson Lechtzin LLP is investigating claims regarding data privacy violations by Ascension Health (“Ascension”). Ascension learned of suspicious activity on or about May 8, 2024. To join this case, go HERE.

About Ascension Health

Ascension is a prominent non-profit health system in the nation and operates under Catholic principles.

What happened?

On or about May 8, 2024, Ascension detected unauthorized activity in its computer systems. Ascension initiated an investigation, which included retaining consulting cybersecurity experts and notifying the FBI. The investigation determined that between May 7 and 8, 2024, a cybercriminal accessed files containing personal information about Ascension’s patients and employees. This information included names, medical records, payment details, insurance information, government identification numbers, and other personal data such as dates of birth and addresses. Approximately 6 million individuals have been affected by this data breach.

How can I protect my personal data?

If you receive a data breach notification, you must guard against possible misuse of your personal information, including identity theft and fraud, by regularly reviewing your account statements and monitoring your credit reports for suspicious or unauthorized activity. Additionally, you should consider legal options for mitigating such risks.

Edelson Lechtzin LLP is investigating a class action lawsuit to seek legal remedies for customers whose sensitive personal and patient data may have been compromised by the Ascension data breach.

For more information, please contact:

Marc H. Edelson, Esq.
EDELSON LECHTZIN LLP
411 S. State Street, Suite N-300
Newtown, PA 18940
Phone: 844-696-7492
Email: medelson@edelson-law.com
Web:  www.edelson-law.com 

About Edelson Lechtzin LLP
Edelson Lechtzin LLP is a national class action law firm with offices in Pennsylvania and California. In addition to cases involving data breaches, our lawyers focus on class and collective litigation in cases alleging securities and investment fraud, violations of the federal antitrust laws, employee benefit plans under ERISA, wage theft and unpaid overtime, consumer fraud, and catastrophic injuries.

This press release may be considered Attorney Advertising in some jurisdictions. No class has been certified in this case, so counsel does not represent you unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing now. Your ability to share in any potential future recovery does not depend on serving as lead plaintiff.

View original content to download multimedia:https://www.prnewswire.com/news-releases/data-breach-alert-edelson-lechtzin-llp-is-investigating-claims-on-behalf-of-ascension-health-customers-whose-data-may-have-been-compromised-302337976.html

SOURCE Edelson Lechtzin LLP

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