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<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" xmlns:media="http://search.yahoo.com/mrss/" > <channel> <title>Journal for Clinical Studies</title> <atom:link href="https://journalforclinicalstudies.com/feed/" rel="self" type="application/rss+xml" /> <link>https://journalforclinicalstudies.com</link> <description>Your resource for Multisite Studies</description> <lastBuildDate>Thu, 18 Sep 2025 10:19:22 +0000</lastBuildDate> <language>en-GB</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=6.8.2</generator> <image> <url>https://journalforclinicalstudies.com/wp-content/uploads/2023/10/Favicon-JCS-150x150.png</url> <title>Journal for Clinical Studies</title> <link>https://journalforclinicalstudies.com</link> <width>32</width> <height>32</height></image> <item> <title>Advarra Launches AI- and Data-backed Study Design Solution to Improve Operational Efficiency in Clinical Trials</title> <link>https://journalforclinicalstudies.com/advarra-launches-ai-and-data-backed-study-design-solution-to-improve-operational-efficiency-in-clinical-trials/</link> <dc:creator><![CDATA[theArchitect]]></dc:creator> <pubDate>Thu, 18 Sep 2025 10:19:21 +0000</pubDate> <category><![CDATA[Regional News]]></category> <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25092</guid> <description><![CDATA[<p>Advarra, the market leader in regulatory reviews and a leading provider of clinical research technology, today announced the launch of its Study Design solution, which uses AI- and data-driven insights to help life sciences companies design protocols for greater operational efficiency in the real world. Study Design solution evaluates a protocol’s feasibility by comparing it […]</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/advarra-launches-ai-and-data-backed-study-design-solution-to-improve-operational-efficiency-in-clinical-trials/">Advarra Launches AI- and Data-backed Study Design Solution to Improve Operational Efficiency in Clinical Trials</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></description> <content:encoded><![CDATA[<p><a href="https://www.advarra.com/" target="_blank" rel="noreferrer noopener">Advarra</a>, the market leader in regulatory reviews and a leading provider of clinical research technology, today announced the launch of its Study Design solution, which uses AI- and data-driven insights to help life sciences companies design protocols for greater operational efficiency in the real world.</p> <p>Study Design solution evaluates a protocol’s feasibility by comparing it to similar trials using Braid<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" />, Advarra’s <a href="https://www.advarra.com/news/advarra-debuts-braid-to-unlock-operational-intelligence-and-workflow-automation-in-clinical-trials-through-ai/" target="_blank" rel="noreferrer noopener">newly launched data and AI engine</a>. Braid is powered by a uniquely rich set of digitised protocol-related documents and operational data from over 30,000 historical studies conducted by 3,500 sponsors. Drawing on Advarra’s institutional review board (IRB) and clinical trial systems, this dataset spans diverse trial types and therapeutic areas, provides granular detail on schedules of assessment and tracks longitudinal study modifications, giving sponsors deeper insights than solutions based only on in-house or public datasets. </p> <p>“Too often, clinical trial protocols are developed without the benefit of robust comparative intelligence, leading to inefficient designs and operations,” said Laura Russell, senior vice president, head of data and AI product development at Advarra. “By drawing on the industry’s largest and richest operational dataset, Advarra’s Study Design solution delivers deeper insights into the feasibility of a protocol’s design. It helps sponsors better anticipate downstream operational challenges, make more informed decisions to simplify trial designs and accelerate protocol development timelines.”</p> <p>Advarra’s Study Design solution can be used to optimise a protocol prior to final submission or for retrospective analyses. The solution provides insights on design factors that drive operational feasibility, such as the impact of eligibility criteria, burdensomeness of the schedule of assessment on sites and participants and reasons for amendments. Study teams receive custom benchmarking that allows for operational risk assessments through tailored data visualisations and consultations with Advarra’s data and study design experts. Technical teams can work directly within Advarra’s secure, self-service insights workspace to explore operational data for the purpose of powering internal analyses, models and business intelligence tools.</p> <p>“Early pilots have already demonstrated measurable impact,” added Russell. “In one engagement, benchmarking a sponsor’s protocol against comparable studies revealed twice as many exclusion criteria and 60 percent more site visits than industry benchmarks. With these insights, the sponsor saw a path to streamline future trial designs by removing unnecessary criteria, clustering procedures and adopting hybrid visit models, ultimately reducing site burden and making participation easier for patients.”</p> <p>Study Design solution is the first in a series of offerings by Advarra that will be powered by Braid. Future applications will extend insights beyond protocol design to improve study startup, enhance collaboration and better support sites.</p> <p>To learn more about Study Design solution or to request a consultation, visit advarra.com/study-design.</p> <p><strong>About Advarra</strong><br>Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Advarra is number one in research review services, a leader in site and sponsor technology, and is trusted by the top 50 global biopharma sponsors, top 20 CROs, and 50,000 site investigators worldwide. Advarra solutions enable collaboration, transparency, and speed to optimize trial operations, ensure patient safety and engagement, and reimagine clinical research while improving compliance. For more information, visit <a href="https://c212.net/c/link/?t=0&l=en&o=4485081-1&h=2380347731&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4407469-1%26h%3D3684560095%26u%3Dhttps%253A%252F%252Fwww.advarra.com%252F%26a%3Dadvarra.com&a=advarra.com" target="_blank" rel="noreferrer noopener">advarra.com</a>.</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/advarra-launches-ai-and-data-backed-study-design-solution-to-improve-operational-efficiency-in-clinical-trials/">Advarra Launches AI- and Data-backed Study Design Solution to Improve Operational Efficiency in Clinical Trials</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></content:encoded> </item> <item> <title>CPHI Frankfurt 2025 to welcome more than 60,000 pharma professionals as the global event returns to Germany</title> <link>https://journalforclinicalstudies.com/cphi-frankfurt-2025-to-welcome-more-than-60000-pharma-professionals-as-the-global-event-returns-to-germany/</link> <dc:creator><![CDATA[theArchitect]]></dc:creator> <pubDate>Mon, 08 Sep 2025 13:15:59 +0000</pubDate> <category><![CDATA[Regional News]]></category> <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25086</guid> <description><![CDATA[<p>Informa Markets will once again welcome the global pharmaceutical industry to CPHI Frankfurt 2025, running from October 28 to 30 at Messe Frankfurt. The three-day event is expected to draw more than 63,000 attendees, with six content theatres, more than 2,000 exhibitors, and a packed programme dedicated to networking and innovation. Celebrating its 36th year, CPHI […]</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/cphi-frankfurt-2025-to-welcome-more-than-60000-pharma-professionals-as-the-global-event-returns-to-germany/">CPHI Frankfurt 2025 to welcome more than 60,000 pharma professionals as the global event returns to Germany</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></description> <content:encoded><![CDATA[<p>Informa Markets will once again welcome the global pharmaceutical industry to<a href="https://tracking.us.nylas.com/l/6827a31313234cee9654bc63027cab72/0/0cbe42738f75f5c0feea5222ef7cf99da49f0aacca5bd440a7020922ea95e5b4?cache_buster=1757334175" target="_blank" rel="noreferrer noopener"> </a><a href="https://www.cphi.com/europe/en/home.html" target="_blank" rel="noreferrer noopener">CP</a><a href="https://tracking.us.nylas.com/l/6827a31313234cee9654bc63027cab72/1/a08670b56daf561e9f028a5cf72dc7597855bc6a258c888fbdb97e44a7863a47?cache_buster=1757334175" target="_blank" rel="noreferrer noopener">HI Frankfurt 2025</a>, running from October 28 to 30 at Messe Frankfurt. The three-day event is expected to draw more than 63,000 attendees, with six content theatres, more than 2,000 exhibitors, and a packed programme dedicated to networking and innovation.</p> <p>Celebrating its 36th year, CPHI Frankfurt remains the largest and most influential pharmaceutical event globally, bringing together professionals from across the drug development and manufacturing ecosystem. The event is organised by Informa Markets, a division of Informa PLC, which delivers B2B events across global industries.</p> <p>“CPHI is more than an event, it’s a global experience,” said Tara Dougal, event director, CPHI Frankfurt. “It’s the one place each year where the full pharmaceutical supply chain comes together to collaborate, build relationships, and get business done.”</p> <p>Following a record-setting 2024 event in Milan that drew 59,000 attendees, this year’s event aims to surpass that benchmark. In recent years, CPHI has expanded its content and exhibitor zones to reflect industry diversification, adding bioproduction, finished dosage formulation, drug delivery, and packaging alongside its traditional strength in APIs.</p> <p>In response to continued market growth and emerging industry trends, CPHI Frankfurt 2025 will introduce several new feature zones aimed at supporting innovation, diversification, and deeper sector engagement. These zones will spotlight areas such as digital health technologies, AI-powered drug development, and sustainable pharma manufacturing, reflecting the industry’s evolving priorities and creating new opportunities for exhibitors and attendees alike.</p> <p>“The new zones are designed to keep pace with where the market is going,” said Dougal. “They’re a direct response to rising demand from both attendees and exhibitors for more focused, future-looking areas within the show.”</p> <p>Attendees can also access a robust line-up of features that enhance both business outcomes and professional development:</p> <p>● Six content theatres, running across all three days, offering insight into market trends, R&D, manufacturing, and regulation.<br></p> <p>● The CPHI Awards and Celebration, recognising innovation and leadership across 14 categories, including Women in Pharma and Future Leader of the Year.<br></p> <p>● Happy hour networking events on days one and two, designed to foster informal connections.<br></p> <p>● An event planner app with agenda-building and real-time floor navigation features, remaining active post-show to support follow-up.<br></p> <p>“Whether you’re a first-time attendee or a returning exhibitor, planning is key,” Dougal said. “Our digital platform helps attendees get the most value by pre-booking meetings, building agendas, and navigating efficiently on site.”</p> <p>The CPHI portfolio includes 10 international events spanning Europe, the Americas, the Middle East, and Asia. The newest addition, CPHI Middle East, launched in Riyadh in 2024 and will return in April 2026.</p> <p><strong>About Informa Markets</strong></p> <p>Informa Markets creates platforms for industries and specialist markets to trade, innovate, and grow. As part of Informa PLC, it delivers more than 450 B2B events annually across key sectors including healthcare, life sciences, construction, and fashion. The company’s mission is to foster global communities, enabling meaningful connections and commercial success.</p> <p>To learn more about CPHI Frankfurt, visit the website <a href="https://www.cphi.com/europe/en/home.html" target="_blank" rel="noreferrer noopener">here</a></p> <p><strong>Media Contact:</strong></p> <p>Aranda Rahbarkouhi<br>ramarketing<br><a href="https://tracking.us.nylas.com/l/6827a31313234cee9654bc63027cab72/3/88cb56db523a945c4052444421f1b2b13a5608c05421cf18ca6923dfbacfded9?cache_buster=1757334175" target="_blank" rel="noreferrer noopener">aranda@ramarketingpr.com</a></p> <p></p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/cphi-frankfurt-2025-to-welcome-more-than-60000-pharma-professionals-as-the-global-event-returns-to-germany/">CPHI Frankfurt 2025 to welcome more than 60,000 pharma professionals as the global event returns to Germany</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></content:encoded> </item> <item> <title>MultiOmic Health and BIO4 Campus Sign MoU to Advance Precision Medicine and Support Bioeconomy Growth in Serbia</title> <link>https://journalforclinicalstudies.com/multiomic-health-and-bio4-campus-sign-mou-to-advance-precision-medicine-and-support-bioeconomy-growth-in-serbia/</link> <dc:creator><![CDATA[theArchitect]]></dc:creator> <pubDate>Thu, 04 Sep 2025 09:58:32 +0000</pubDate> <category><![CDATA[Regional News]]></category> <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25072</guid> <description><![CDATA[<p>London, UK, and Belgrade, Serbia, 4 September, 2025 / Sciad Communications / MultiOmic Health Limited (‘MOH’), an artificial intelligence (AI)-enabled precision medicine biotechnology company, and BIO4 Campus (‘BIO4’), the Republic of Serbia’s flagship biotechnology and life sciences hub, today announced the signing of a Memorandum of Understanding (MoU) to explore collaborative opportunities in biomedicine, biotechnology and bioinformatics, with a strong emphasis on […]</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/multiomic-health-and-bio4-campus-sign-mou-to-advance-precision-medicine-and-support-bioeconomy-growth-in-serbia/">MultiOmic Health and BIO4 Campus Sign MoU to Advance Precision Medicine and Support Bioeconomy Growth in Serbia</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></description> <content:encoded><![CDATA[<p>London, UK, and Belgrade, Serbia, 4 September, 2025 <strong>/</strong> <strong><a href="https://email.cisionone.cision.com/c/eJwszkuO8yAQBODTwI4IN-8Fi2x8jaih2wn6_fgHMvH1Rx7N9itVqShDrFZLzlNwPvkELslXpsgGY0CDCyXjeSoWHZhAGEAvVGTLPpZk0lRTYPaPyZUatbFOkxNWj0b8r32pDdvKfShPSyjWV_IqxlT22xXINb_e7_9DmLuAWcB8nudt1IZ0q8cmYD6-u9r5HAJmuTE1VJ1XxsGqUf6Fxx8Ic58sgI6y50_rz7Y3vG7w_lyPgms9tnGNyvHuzNvVn4ojg5qUCdorWxBUgWIVhBqDxoWsj_KT4ScAAP__a7ZZSw" target="_blank" rel="noreferrer noopener">Sciad Communications</a> / <a href="https://email.cisionone.cision.com/c/eJwszUuO6yAQheHVmBlRAWUeAwaZZBtRQZVjdCG-bbuz_pZbPf2Ojn7ONlYEJdmE2Sef7JzUmrGCqxb9wsQM7AIgEboCZjEQiVXLPpbkkqkpiPinmUuN4HAGnieEo7H8a196UOuyH9rzEgr6yl7HmMr7dg2q5_U8_x-Tu0_2MdnH-O5n20art1Won-tkH2oIN9K7dKFDdOP8C88_mNzdoLUQ1Z4_bX-1d6MrL-9X3wr1uo3jVrehjnMXGdfflJkdAWsXwGssZHWxBbUNNQaghdFH9cn2JwAA__93BVaS" target="_blank" rel="noreferrer noopener">MultiOmic Health Limited</a> </strong>(‘MOH’), an artificial intelligence (AI)-enabled precision medicine biotechnology company, and <a href="https://email.cisionone.cision.com/c/eJwszU1uAjEMxfHTTHZBzpfjLLJgwzVQHBuIOsO0E8T5K6puf09Pf6meegSj1eWEBYtPxTyqEsVMjAkROKGAY-abCEMM4ByZUZG4hOJ6yap4dYk7QYgJJC0R5hD9Gj92a2PVY1qUW-aIXdASFX6ePoNZ6-P1-p5LOC_-svgLjz2ejrn4i9lURrOHrtqm2iH1D67_sISzi94DmaO-x3Efz9E-VX3e153b2vdtnvq-mfk6VLfP33GS0EBsyIA2cvOWPUfrc6cM7SYRybyr_w0AAP__hepSKA" target="_blank" rel="noreferrer noopener">BIO4 Campus</a> (‘BIO4’), the Republic of Serbia’s flagship biotechnology and life sciences hub, today announced the signing of a Memorandum of Understanding (MoU) to explore collaborative opportunities in biomedicine, biotechnology and bioinformatics, with a strong emphasis on AI applications.</p> <p>BIO4 and MOH will work together to foster the growth of Serbia’s bioeconomy ecosystem by identifying and developing opportunities for joint research and innovation. Collaboration will initially focus on cardio-renal-metabolic diseases through integrative medical data and multi-omics approaches (genetics, epigenetics, transcriptomics, proteomics and metabolomics). This research will discover patient endotypes with distinct clinical phenotypes and omics signatures, develop AI-enabled tools to stratify those patient endotypes at earlier disease stages, and identify and validate corresponding patient stratified drug targets. These efforts will enable a more personalised approach to patient care.</p> <p>Insights from this research will enable the joint development of AI-based Software as Medical Device (SaMD) and In Vitro Diagnostic (IVD) products that will optimise patient care pathways using existing treatment options. In parallel, MOH will also devise new superior treatment concepts, generate corresponding drug candidates and conduct clinical trials in partnership with its biopharma industry collaborators.</p> <p>‘By joining forces with BIO4 and its network of leading Serbian research and clinical institutions, we see a strong opportunity to advance the development of next-generation precision medicine solutions,’ said Robert Thong, CEO of MultiOmic Health. ‘This collaboration reinforces our commitment to harnessing AI, data science and experimental biology to improve patient outcomes in cardio-renal-metabolic diseases globally.’</p> <p>‘BIO4 Campus was created to be a catalyst for Serbia’s bioeconomy and an international hub for innovation,’ said Smiljana Krivokuća, CEO of BIO4. ‘We are delighted to welcome MultiOmic Health as a partner in this mission and look forward to exploring joint opportunities that combine their expertise in precision medicine with our ecosystem’s strengths in biotechnology, clinical research and bioinformatics.’</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/multiomic-health-and-bio4-campus-sign-mou-to-advance-precision-medicine-and-support-bioeconomy-growth-in-serbia/">MultiOmic Health and BIO4 Campus Sign MoU to Advance Precision Medicine and Support Bioeconomy Growth in Serbia</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></content:encoded> </item> <item> <title>SK bioscience Submits IND for Phase 3 Clinical Trial of 2 Dose Varicella Vaccine</title> <link>https://journalforclinicalstudies.com/sk-bioscience-submits-ind-for-phase-3-clinical-trial-of-2-dose-varicella-vaccine/</link> <dc:creator><![CDATA[theArchitect]]></dc:creator> <pubDate>Thu, 04 Sep 2025 09:57:53 +0000</pubDate> <category><![CDATA[Regional News]]></category> <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25065</guid> <description><![CDATA[<p>SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that it has submitted an IND (Investigational New Drug application) to the Ministry of Food and Drug Safety for a global Phase 3 clinical trial of SKYVaricella to add the 2-dose (two-shot) indication, aligning with […]</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/sk-bioscience-submits-ind-for-phase-3-clinical-trial-of-2-dose-varicella-vaccine/">SK bioscience Submits IND for Phase 3 Clinical Trial of 2 Dose Varicella Vaccine</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></description> <content:encoded><![CDATA[<p>SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that it has submitted an IND (Investigational New Drug application) to the Ministry of Food and Drug Safety for a global Phase 3 clinical trial of SKYVaricella to add the 2-dose (two-shot) indication, aligning with evolving international standards that increasingly recommend two doses to provide stronger, longer-lasting protection against varicella. The trial will evaluate the immunogenicity and safety of two doses in roughly 800 children aged 12 months to 12 years, with completion targeted by 2027.</p> <p>Varicella vaccines have effectively reduced disease and complications with a single dose, which has been the standard in many countries. However, breakthrough infections may occur over time and international standards are shifting toward a 2-dose schedule to provide stronger, longer-lasting immunity and reduce community transmission.</p> <p>WHO’s SAGE (Strategic Advisory Group of Experts on Immunisation) officially recommended a 2-dose varicella vaccination in March 2025, boosting demand in global procurement markets including PAHO. The United States implemented a 2-dose schedule in 2006, cutting varicella incidence by over 85%, and countries such as Germany and Japan have since incorporated 2-dose regimens into their national immunisation programs. Since its launch in Korea in 2018, SKYVaricella obtained WHO PQ certification in 2019, becoming the second vaccine worldwide to achieve this, entering the international procuremen market. It has been administered to over 5 million people globally, with supply expanded through Korea’s National Immunisation Program, private healthcare providers, and international tenders such as PAHO. Recently, the company signed an additional supply agreement with PAHO for 2025-2027 and plans to accelerate its entry into the global varicella vaccine market through the development of SKYVaricella 2-dose regimen.</p> <p>Global Market Insights projects that the global varicella vaccine market will grow from USD 3.4 billion (KRW 4.7 trillion) in 2024 to USD 6.3 billion (KRW 8.8 trillion) by 2034, at an average annual growth rate of 6.5%.</p> <p>Ryu Ji-hwa, Head of Development Department of SK bioscience, said, ‘Our 2-dose varicella vaccine is a strategic pipeline that directly reflects updated international standards and rising market demand. Building on our WHO PQ-backed procurement experience and R&D achievements, we aim to complete development quickly and compete globally with reliable production and superior immunogenicity.’</p> <p><strong>About SK bioscience</strong></p> <p><a href="https://www.skbioscience.com/en/main" target="_blank" rel="noopener">SK bioscience </a>is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions.</p> <p><strong>SK bioscience Communications Team</strong></p> <p>Changhyun Jin (jin99@sk.com) </p> <p>Jeannie S. Pak (j.pak@sk.com)</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/sk-bioscience-submits-ind-for-phase-3-clinical-trial-of-2-dose-varicella-vaccine/">SK bioscience Submits IND for Phase 3 Clinical Trial of 2 Dose Varicella Vaccine</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></content:encoded> </item> <item> <title>Veeva Announces Collaboration with Global Biotech to Further Accelerate Clinical Trial Innovation</title> <link>https://journalforclinicalstudies.com/veeva-announces-collaboration-with-global-biotech-to-further-accelerate-clinical-trial-innovation/</link> <dc:creator><![CDATA[theArchitect]]></dc:creator> <pubDate>Thu, 04 Sep 2025 09:56:31 +0000</pubDate> <category><![CDATA[Regional News]]></category> <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25074</guid> <description><![CDATA[<p>Veeva Systems (NYSE: VEEV) today announced a collaboration with Amgen to advance clinical trial innovation. As a global leader in biotechnology, Amgen will employ the Veeva Clinical Platform to support and identify efficiencies across the clinical trial process, building on the company’s commitment to accelerating the development of new medicines for patients with serious diseases. “In collaboration with […]</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/veeva-announces-collaboration-with-global-biotech-to-further-accelerate-clinical-trial-innovation/">Veeva Announces Collaboration with Global Biotech to Further Accelerate Clinical Trial Innovation</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></description> <content:encoded><![CDATA[<p><a href="https://www.veeva.com/eu/" target="_blank" rel="noreferrer noopener">Veeva Systems</a> (NYSE: VEEV) today announced a collaboration with Amgen to advance clinical trial innovation. As a global leader in biotechnology, Amgen will employ the <a href="https://www.veeva.com/eu/products/veeva-clinical-platform/" target="_blank" rel="noreferrer noopener">Veeva Clinical Platform</a> to support and identify efficiencies across the clinical trial process, building on the company’s commitment to accelerating the development of new medicines for patients with serious diseases.</p> <p>“In collaboration with Veeva, we’re leveraging advanced technology to unlock new capabilities for our end-to-end trial operations which are expected to further strengthen our ability to bring innovative treatments to patients with speed and scale,” said Scott Skellenger, senior vice president and chief information officer at Amgen.</p> <p>“We’re excited to help Amgen further advance clinical development. Veeva Clinical Platform will provide the backbone for standard and connected processes that can speed the delivery of life-saving drugs to patients in need,” said Jim Reilly, president of Veeva Development Cloud.</p> <p>As part of the collaboration, <a href="https://www.veeva.com/eu/services/business-consulting-services/" target="_blank" rel="noreferrer noopener">Veeva Business Consulting</a> will support Amgen through implementation and change management.</p> <p><strong>About Veeva Clinical Platform</strong></p> <p>Veeva Clinical Platform is a complete and connected platform across clinical operations and data applications. This end-to-end platform includes CTMS, EDC, clinical workbench (CDB), RTSM, eCOA, eTMF, Site Connect, Study Training, and more. Connected products streamline clinical trials from study start-up to close and automate a connected data flow. To learn more about Veeva Clinical Platform, visit <a href="https://www.veeva.com/eu/products/veeva-clinical-platform/" target="_blank" rel="noreferrer noopener">veeva.com/eu/VeevaClinicalPlatform</a>.</p> <p><strong>About Veeva Systems</strong></p> <p><a></a>Veeva delivers the industry cloud for life sciences with software, data, and business consulting. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,500 customers, ranging from the world’s largest biopharmaceutical companies to emerging biotechs. As a <a href="https://www.veeva.com/pbc/" target="_blank" rel="noreferrer noopener">Public Benefit Corporation</a>, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit <a href="http://veeva.com/eu" target="_blank" rel="noreferrer noopener">veeva.com/eu</a>.</p> <p><strong>Veeva Forward-looking Statements</strong></p> <p>This release contains forward-looking statements regarding Veeva’s products and services and the expected results or benefits from use of our products and services. These statements are based on our current expectations. Actual results could differ materially from those provided in this release and we have no obligation to update such statements. There are numerous risks that have the potential to negatively impact our results, including the risks and uncertainties disclosed in our filing on Form 10-Q for the period ended April 30, 2025, which you can find <em><a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/0001393052/000139305225000042/veev-20250430.htm#i7e129a0ad48d459ea13c21cd7e2de073_124" target="_blank" rel="noreferrer noopener">here</a></em> (a summary of risks which may impact our business can be found on pages 32 and 33), and in our subsequent SEC filings, which you can access at <em><a href="https://www.sec.gov/" target="_blank" rel="noreferrer noopener">sec.gov</a></em></p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/veeva-announces-collaboration-with-global-biotech-to-further-accelerate-clinical-trial-innovation/">Veeva Announces Collaboration with Global Biotech to Further Accelerate Clinical Trial Innovation</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></content:encoded> </item> <item> <title>Atelerix and Rodon Global Partner to Integrate Cryo-free Preservation Technology into Specialist Logistics Solutions</title> <link>https://journalforclinicalstudies.com/atelerix-and-rodon-global-partner-to-integrate-cryo-free-preservation-technology-into-specialist-logistics-solutions/</link> <dc:creator><![CDATA[theArchitect]]></dc:creator> <pubDate>Thu, 04 Sep 2025 09:44:12 +0000</pubDate> <category><![CDATA[Regional News]]></category> <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25067</guid> <description><![CDATA[<p>Atelerix, a biotech company revolutionising cell preservation and biological transport with its pioneering hydrogel encapsulation technology, today announced an agreement with Rodon Global (“Rodon”), the established freight company focused on clinical trials and drug discovery headquartered in South Africa. The collaboration comes at a pivotal time as Rodon actively expands operations across the United States, […]</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/atelerix-and-rodon-global-partner-to-integrate-cryo-free-preservation-technology-into-specialist-logistics-solutions/">Atelerix and Rodon Global Partner to Integrate Cryo-free Preservation Technology into Specialist Logistics Solutions</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></description> <content:encoded><![CDATA[<p></p> <ul class="wp-block-list"><li><em>Initial agreement to incorporate Atelerix’s non-cryogenic cell preservation technology into international freight and logistics services for drug discovery and clinical trials</em></li> <li><em>Partnership showcased at SACRA (South African Clinical Research Association), Pretoria, 1–2 October 2025</em></li></ul> <p>Atelerix, a biotech company revolutionising cell preservation and biological transport with its pioneering hydrogel encapsulation technology, today announced an agreement with Rodon Global (“Rodon”), the established freight company focused on clinical trials and drug discovery headquartered in South Africa. The collaboration comes at a pivotal time as Rodon actively expands operations across the United States, UK, South Africa, and Singapore. By integrating Atelerix’s unique cryo-free preservation products within Rodon’s dynamic logistics offering, the collaboration will significantly broaden access to safe shipping and storage solutions for temperature-sensitive biomaterials, without freezing.</p> <p>Through an initial MoU, Rodon will begin offering Atelerix’s portfolio of hypothermic preservation solutions to customers, providing new options to enhance efficiency across biomedical research and therapeutic development workflows. The mutually-beneficial collaboration grants Atelerix access to a new customer base via a trusted industry partner, whilst enabling Rodon to scale its services through a unique model that addresses traditional challenges in cold-chain logistics. This agreement follows the appointment of MineBio as Atelerix’s exclusive distributor in China<sup>1</sup>, further extending the Company’s global network of logistics partners to deliver a cryo-free, cost-efficient transport solution worldwide.</p> <p>Atelerix’s patented hydrogels directly address cryologistic bottlenecks by stabilising membrane integrity and preserving biological function of cells and other biological substances during transport. Samples can remain in a ready-to-use state at ambient temperatures for up to two weeks, reducing waste and energy consumption, and simplifying shipping and handling protocols. Optimised for whole blood, primary cells, plated cell models, organoids, tissues, and viruses, the technology is applicable across life science and healthcare. It is particularly valuable for cell and gene therapy manufacturing, where it offers a flexible solution for preservation across the full workflow.</p> <p><strong>Alastair Carrington, CEO, Atelerix, commented<em>: </em></strong><em>“The global demand for inexpensive, efficient solutions for storage and transport of biological substances is continually increasing, leading to an urgent unmet need for innovative solutions, which our experienced team of hogs can provide. Working alongside Rodon and our network of global distributors, we are expanding our reach to include the booming South African life science sector, catapulting adoption of our unique technologies in the region, and beyond. We look forward to joining Rodon at SACRA in October to showcase the enormous potential of our collaboration.”</em></p> <p><strong>Leonard Neil Lazarus, CEO, Rodon Global, added:</strong> <em>“Atelerix’s innovative approach to cell preservation will revolutionise biological transport worldwide, overcoming supply chain challenges associated with temperature sensitive materials, particularly in the drug discovery and clinical research sectors. This partnership represents a significant milestone and differentiator for Rodon, allowing us to overcome these challenges and continue to scale, supporting our life science customers to develop and manufacture novel therapeutics.</em></p> <p></p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/atelerix-and-rodon-global-partner-to-integrate-cryo-free-preservation-technology-into-specialist-logistics-solutions/">Atelerix and Rodon Global Partner to Integrate Cryo-free Preservation Technology into Specialist Logistics Solutions</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></content:encoded> </item> <item> <title>Friends of Cancer Research and MMS Collaborate to Develop Decision Frameworks for Interim Overall Survival Data in Oncology Trials</title> <link>https://journalforclinicalstudies.com/friends-of-cancer-research-and-mms-collaborate-to-develop-decision-frameworks-for-interim-overall-survival-data-in-oncology-trials/</link> <dc:creator><![CDATA[theArchitect]]></dc:creator> <pubDate>Wed, 20 Aug 2025 13:24:10 +0000</pubDate> <category><![CDATA[Regional News]]></category> <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25057</guid> <description><![CDATA[<p>MMS, a global, data-focused clinical research organization (CRO), announced today that it has been chosen by Friends of Cancer Research (Friends), a leading nonprofit dedicated to accelerating innovation in cancer research, to support the development of practical decision frameworks to inform the interpretation of interim overall survival (OS) data in oncology clinical trials. The collaboration […]</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/friends-of-cancer-research-and-mms-collaborate-to-develop-decision-frameworks-for-interim-overall-survival-data-in-oncology-trials/">Friends of Cancer Research and MMS Collaborate to Develop Decision Frameworks for Interim Overall Survival Data in Oncology Trials</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></description> <content:encoded><![CDATA[<p>MMS, a global, data-focused clinical research organization (CRO), announced today that it has been chosen by Friends of Cancer Research (<em>Friends</em>), a leading nonprofit dedicated to accelerating innovation in cancer research, to support the development of practical decision frameworks to inform the interpretation of interim overall survival (OS) data in oncology clinical trials.</p> <p>The collaboration addresses a longstanding challenge in cancer drug development: <em>how to assess long-term treatment benefit when OS data remain immature</em>. In many oncology studies, developers use endpoints such as progression-free survival (PFS) and objective response rate (ORR) as an initial indicator of treatment efficacy. However, evaluating OS data at the same interim point can complicate the assessment of long-term benefit or harm. To provide clarity, Friends has convened a consortium of stakeholders to develop and evaluate different modeling scenarios, including crossover effects and delayed treatment benefits.</p> <p><em>Friends </em>selected MMS to lead simulation and modeling efforts for this project based on both its simulation platform, KerusCloud®, and its deep bench of regulatory and statistical experts. The MMS platform enables realistic modeling of oncology endpoints and allows stakeholders to explore different scenarios and decision thresholds, providing a clear view of the potential risks and benefits associated with acting on immature data in oncology clinical trials, and supporting more informed decisions earlier in the trial process.</p> <p>“As timely access to innovative cancer therapies remains a key factor for patients, this initiative represents an important step toward optimal acceleration,” said Jeff Allen, PhD, President and CEO, Friends of Cancer Research. “At <em>Friends</em>, we work with key stakeholders to generate the evidence necessary to understand a problem, and develop data-driven policy solutions to address and overcome that problem; all while keeping the patients front of mind. We are excited to partner with MMS along with the consortium who bring a combination of statistical depth, real-world understanding of oncology trial design, and powerful simulation tools to help tackle these challenges.”</p> <p><strong>Improving Oncology Clinical Trials with the Right Technology and the Right Stakeholders</strong></p> <p>“Friends of Cancer Research has long been a catalyst for forward-thinking collaboration in oncology, and we are grateful they have trusted MMS to support this vital initiative,” said Uma Sharma, PhD, CEO at MMS. Having supported several key oncology approvals, we are uniquely positioned to help model the right questions and deliver practical frameworks that will shape future regulatory guidance and support better decision-making across the field.”</p> <p>“By combining our regulatory insight with advanced simulation capabilities, we are helping develop practical tools and decision frameworks that give developers greater confidence to act on early data, and ultimately improve access for patients,” added Aiden Flynn, Sr. VP Strategic Statistical Consulting at MMS.</p> <p>The collaboration is expected to result in practical guidance and a simulation toolbox that can be shared broadly across the oncology community, helping stakeholders better anticipate the implications of interim OS data on regulatory decisions. By equipping researchers with a practical, scientifically robust toolkit, this program promotes a consistent and transparent approach to evaluating early survival signals, supports timely decision-making, and fosters continued innovation in cancer drug development. To learn about the Interim OS Project, visit <a href="https://biostratamarketing.acemlnb.com/lt.php?x=3DZy~GE3VaOf5aKs__xGgeahAXVTjNgkluUwjHg4JXCg78JAzEy.1.Jt2nRzjd91k_YwX5PEMnKd7pz6" target="_blank" rel="noreferrer noopener">https://friendsofcancerresearch.org/interim-os</a>, and learn more about KerusCloud at <a href="https://biostratamarketing.acemlnb.com/lt.php?x=3DZy~GE3VaOf5aKs__xGgeahAXVTjNgkluUwjHg4JXCg78JAzEy.1.Jt2nRzjd91k_YwX5PEMnKd7pz7" target="_blank" rel="noreferrer noopener">https://mmsholdings.com/ai-technology/keruscloud-clinical-trial-simulation/</a>.</p> <p><strong>About Friends of Cancer Research</strong><br>Friends of Cancer Research (<em>Friends</em>) powers advances in science and policy that speed life-saving treatments to patients. <em>Friends </em>aims to accelerate cutting edge cancer care that both extends and improves quality of life for patients. To accomplish this, we leverage groundbreaking collaborations, generate scientific evidence, and integrate patient input to shape public policy. For more information, please visit <a href="https://biostratamarketing.acemlnb.com/lt.php?x=3DZy~GE3VaOf5aKs__xGgeahAXVTjNgkluUwjHg4JXCg78JAzEy.1.Jt2nRzjd91k_YwX5PEMnKd7pz8" target="_blank" rel="noreferrer noopener">https://friendsofcancerresearch.org</a>.</p> <p><strong>About MMS</strong><br>MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, a 19-year track record, AI technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner. With a global footprint across four continents, MMS maintains an industry-leading customer satisfaction rating. For more information, visit <a href="https://biostratamarketing.acemlnb.com/lt.php?x=3DZy~GE3VaOf5aKs__xGgeahAXVTjNgkluUwjHg4JXCg78JAzEy.1.Jt2nRzjd91k_YwX5PEMnKd7pz9" target="_blank" rel="noreferrer noopener">www.mmsholdings.com</a>.</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/friends-of-cancer-research-and-mms-collaborate-to-develop-decision-frameworks-for-interim-overall-survival-data-in-oncology-trials/">Friends of Cancer Research and MMS Collaborate to Develop Decision Frameworks for Interim Overall Survival Data in Oncology Trials</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></content:encoded> </item> <item> <title>OKYO Pharma Unveils Strong Phase 2 Clinical Trial Results for Urcosimod to Treat Neuropathic Corneal Pain</title> <link>https://journalforclinicalstudies.com/okyo-pharma-unveils-strong-phase-2-clinical-trial-results-for-urcosimod-to-treat-neuropathic-corneal-pain/</link> <dc:creator><![CDATA[chloe euripides]]></dc:creator> <pubDate>Tue, 19 Aug 2025 12:29:01 +0000</pubDate> <category><![CDATA[Regional News]]></category> <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25053</guid> <description><![CDATA[<p>OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod to treat neuropathic corneal pain (NCP), an ocular condition associated with chronic and often severe nerve-related pain but without an FDA-approved therapy, is pleased to announce positive top-line data from the recently closed 18-patient Phase 2 trial of urcosimod (formerly called OK-101) to […]</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/okyo-pharma-unveils-strong-phase-2-clinical-trial-results-for-urcosimod-to-treat-neuropathic-corneal-pain/">OKYO Pharma Unveils Strong Phase 2 Clinical Trial Results for Urcosimod to Treat Neuropathic Corneal Pain</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></description> <content:encoded><![CDATA[<ul class="wp-block-list"><li>After 12 weeks of treatment, 75% of per-protocol patients receiving 0.05% urcosimod showed greater than 80% reduction in neuropathic corneal pain (NCP), as measured by Visual Analogue Scale (VAS), demonstrating highly effective treatment.</li> <li>Urcosimod (0.05%) demonstrated a marked reduction in pain scores as early as Week 4, with sustained efficacy maintained throughout the trial.</li> <li>A statistically significant reduction in mean pain scores was observed from Visit 1 to the end of treatment Visit 4 (p-value = 0.025) in the per-protocol 0.05% urcosimod group, indicating the drug’s effectiveness over the study period.</li> <li>Notably, all these responders entered the study with moderate to severe NCP pain scores despite prior use of maximum medical therapy.</li> <li>No serious adverse events were reported among the 18 patients throughout the trial.</li> <li>Following completion of full data analysis, OKYO plans a meeting with FDA to discuss next steps for urcosimod which has already received Fast Track designation for treating NCP.</li></ul> <p>OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod to treat neuropathic corneal pain (NCP), an ocular condition associated with chronic and often severe nerve-related pain but without an FDA-approved therapy, is pleased to announce positive top-line data from the recently closed 18-patient Phase 2 trial of urcosimod (formerly called OK-101) to treat NCP. OKYO is the first company to conduct a clinical study to treat NCP disease, a major unmet medical need.</p> <p>This randomised, double-masked, placebo-controlled, Phase 2 Proof-of-Concept trial of urcosimod to treat NCP was conducted at a single trial site at Tufts Medical Center in Boston, MA, with Pedram Hamrah, M.D., a leading expert in NCP, as Principal Investigator.</p> <p><strong>Top Line Data</strong><br>Note: Primary Endpoint of Phase 2 trial was change in mean pain scores from baseline (Visit 1, Day 0) to end of treatment (Visit 4, Day 84), as measured by a VAS scale of 0-10.</p> <p>For the per-protocol population, change in mean pain score was 5.5 in the 0.05% urcosimod group and 2.75 in the placebo group, reflecting a 2.75 delta difference between drug and placebo following the 12-week treatment period. Notably, 75% of patients treated with 0.05% urcosimod in this group achieved greater than 80% improvement in pain severity based on VAS scores. Urcosimod (0.05%) demonstrated a marked reduction in pain scores as early as Week 4, with a mean change of 5.25 compared to 3.0 in placebo group. Moreover, for the 0.05% urcosimod group a statistically significant reduction in mean pain scores was observed from Visit 1 to the end of treatment Visit 4 (p-value = 0.025). The placebo group also showed a statistically significant improvement from baseline (Visit 1) to the final visit (Visit 4), with a p-value = 0.035. However, mean improvement seen in the placebo group was only half what was seen for the 0.05% urcosimod group (2.75 <em>vs</em> 5.5). Moreover, for the placebo group’s reduction from Visit 1 to the end of treatment Visit 4, 75% of those patients had only mild NCP pain scores at baseline. In contrast, all the patients in the 0.05% urcosimod group had moderate to severe NCP pain scores, indicating a more challenging baseline condition.</p> <p>In the intent-to-treat population, 67% of patients in the 0.05% urcosimod group demonstrated greater than 50% improvement in pain, as measured by VAS scores, compared to 33% in the placebo group. The mean reduction in pain severity from baseline (Visit 1) to end of treatment (Visit 4), measured by VAS, was 4.2 in the 0.05% urcosimod group and 2.5 in the placebo group.</p> <p>The drug-effect size of 0.05% urcosimod when compared to placebo at week 12, using Cohen-d demonstrated a strong treatment effect (Cohen-d value > 1.2). Cohen-d is a standard statistical measure used to assess and compare the effect size of the trial drug relative to the placebo.</p> <p>“I have been dedicated to the pursuit of a drug to treat NCP for a considerable period of time, and these top-line results, along with the findings of our previous in-house animal model study of urcosimod to treat NCP, are very exciting and extremely encouraging,” said Dr. Hamrah, Vice Chair of Research and Academic Programs for the Department of Ophthalmology at Tufts Medical Center and Principal Investigator of the phase 2 trial of urcosimod. “I find it particularly encouraging that the drug showed a dramatic reduction in VAS pain scores in patients who have particularly high VAS pain scores, indicating a more severe form of the disease.”</p> <p>“We are thrilled with these initial top-line results in patients treated with urcosimod from this first in-human phase 2 trial,” said Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma. “In particular, the results strengthen our conviction that this drug may be particularly effective at showing a significant reduction in pain in patients with a greater degree of neuropathic pain. Throughout the trial we were also pleased by the feedback from patients and are excited about the opportunity to provide relief to NCP patients currently living day-to-day with the life-altering effects of this relentless neuropathic pain. I want to thank Dr. Pedram Hamrah, one of the world’s foremost experts on NCP, and our patients and study site team for their participation and commitment to this important trial of urcosimod to treat NCP.”</p> <p>“I am very proud that OKYO Pharma is pioneering the development of the first topical drug with the potential to treat Neuropathic Corneal Pain, a debilitating disease, which currently has no FDA approved therapy,” said Mr. Gabriele Cerrone, Founder and Chairman of OKYO Pharma. “Our goal now is to bring this drug to the market as quickly as possible to help patients suffering from this terrible disease.”</p> <p>Significant interest in urcosimod has been brought to OKYO’s attention by sufferers of NCP during this phase 2 trial, and OKYO will be pushing to accelerate clinical development of urcosimod with further trials in the near future. In addition, several patients from the just completed trial have also requested availability of the drug through FDA’s “Expanded Access” program (also referred to as “Compassionate Use”) which the Company is planning to arrange, contingent on necessary FDA approvals, for those present patients and future patients who have specifically completed clinical trials on urcosimod.</p> <p>In line with earlier findings from a previously conducted Phase 2 trial to evaluate urcosimod to treat dry eye disease, results from the 0.1% drug treatment group in this trial also showed less efficacy than the 0.05% drug treatment group. OKYO is continuing to evaluate additional data and plans to present a larger data set from the study after ongoing analyses of the data have been completed.</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/okyo-pharma-unveils-strong-phase-2-clinical-trial-results-for-urcosimod-to-treat-neuropathic-corneal-pain/">OKYO Pharma Unveils Strong Phase 2 Clinical Trial Results for Urcosimod to Treat Neuropathic Corneal Pain</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></content:encoded> </item> <item> <title>Affidea Partners with Skin Analytics to Improve Access to Skin Cancer Assessment Across Europe Using AI Technology</title> <link>https://journalforclinicalstudies.com/affidea-partners-with-skin-analytics-to-improve-access-to-skin-cancer-assessment-across-europe-using-ai-technology/</link> <dc:creator><![CDATA[chloe euripides]]></dc:creator> <pubDate>Tue, 19 Aug 2025 12:23:55 +0000</pubDate> <category><![CDATA[Regional News]]></category> <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25051</guid> <description><![CDATA[<p>Affidea, a leading pan-European provider of community-based polyclinics, advanced diagnostics, and multi-specialist care, including oncology, has entered a strategic partnership with Skin Analytics, a pioneering AI company in dermatology care. This collaboration supports Affidea’s long-term vision of leveraging digital innovations to improve patient outcomes as part of its integrated skin cancer care pathway. As part […]</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/affidea-partners-with-skin-analytics-to-improve-access-to-skin-cancer-assessment-across-europe-using-ai-technology/">Affidea Partners with Skin Analytics to Improve Access to Skin Cancer Assessment Across Europe Using AI Technology</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></description> <content:encoded><![CDATA[<p>Affidea, a leading pan-European provider of community-based polyclinics, advanced diagnostics, and multi-specialist care, including oncology, has entered a strategic partnership with Skin Analytics, a pioneering AI company in dermatology care. This collaboration supports Affidea’s long-term vision of leveraging digital innovations to improve patient outcomes as part of its integrated skin cancer care pathway.</p> <p>As part of this partnership, Affidea has implemented Skin Analytics’ DERM, an AI medical device software for the automated analysis of skin lesions. The initial implementation of DERM began in Romania and Lithuania, with Greece to follow in September. These countries were selected based on market analysis, clinical readiness and innovation focus. The aim is to improve patient access to high quality care by introducing clinically validated AI technology into the gold standard skin care pathway already in place. This enables patients’ triage while streamlining workflows. Following this first phase, Affidea plans to roll out the AI solution across additional European markets.</p> <p><strong>Dr Charles Niehaus, Executive Director for Affidea Group, stated:</strong> “<em>Integrating cutting-edge digital innovations into clinical practice is essential to delivering the best possible care for our patients. Our partnership with Skin Analytics marks an exciting milestone, enabling us to leverage AI in supporting early detection of skin cancer </em><em>and to provide even more patients with access to the prevention, diagnosis, and treatment programs we already offer in our dermatology units. This collaboration is not just about introducing new technology — it’s about creating scalable, sustainable solutions that empower patients and clinical teams, address rising demand and bring timely, high-quality care across Europe.”</em></p> <p><strong><em>Neil Daly, Chief Executive Officer & founder, Skin Analytics, stated: </em></strong><em>“We’re incredibly proud to be partnering with Affidea as our first European partner. This collaboration represents a major milestone in our mission to transform access to dermatology care using AI. By combining Affidea’s clinical excellence and pan-European reach with our proven technology, DERM, we have an opportunity to reimagine how skin cancer is identified and managed across the continent. At scale, this partnership will drive earlier diagnoses, improve access to care and support dermatology teams facing rising demand – ultimately marking history for how skin cancer care is delivered and improving outcomes for patients across Europe.”</em></p> <p>Skin cancer remains a significant public health challenge across Europe. According to GLOBOCAN 2022 data, Europe accounts for approximately 10.4 melanoma cases per 100,000 people. Non-melanoma skin cancers were even more prevalent, with over 1.15 million cases in Europe in 2022<sup>1</sup>. This burden continues to grow <em>—</em> age-standardised incidence rates for melanoma have risen sharply over the past decades, and non-melanoma cases now represent nearly 78% of all skin cancer diagnoses.</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/affidea-partners-with-skin-analytics-to-improve-access-to-skin-cancer-assessment-across-europe-using-ai-technology/">Affidea Partners with Skin Analytics to Improve Access to Skin Cancer Assessment Across Europe Using AI Technology</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></content:encoded> </item> <item> <title>ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System</title> <link>https://journalforclinicalstudies.com/onward-medical-receives-fda-ide-approval-to-initiate-the-empower-bp-pivotal-study-with-the-arc-im-system/</link> <dc:creator><![CDATA[chloe euripides]]></dc:creator> <pubDate>Tue, 19 Aug 2025 12:18:42 +0000</pubDate> <category><![CDATA[Regional News]]></category> <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25049</guid> <description><![CDATA[<p>ONWARD Medical N.V. (Euronext: ONWD and US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury and other movement disabilities, today announces that the US Food and Drug Administration (FDA) has approved an investigational device exemption for the ARC-IM System. With this approval, the […]</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/onward-medical-receives-fda-ide-approval-to-initiate-the-empower-bp-pivotal-study-with-the-arc-im-system/">ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></description> <content:encoded><![CDATA[<p></p> <p>ONWARD Medical N.V. (Euronext: ONWD and US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury and other movement disabilities, today announces that the US Food and Drug Administration (FDA) has approved an investigational device exemption for the ARC-IM System. With this approval, the Company can initiate the Empower BP pivotal study to assess the safety and efficacy of its implantable spinal stimulation system to address blood pressure instability after SCI.</p> <p>Empower BP is the Company’s second global pivotal study, and the first to evaluate the implantable ARC-IM System. The randomized, double-blinded, sham-controlled study is expected to involve approximately 20 leading neurorehabilitation and neurosurgical research centers across the US, Canada and Europe, with first patient enrollment anticipated before the end of the year. The study will target participants with injuries at spinal cord levels C2-T6, injury severities of AIS A-D, and blood pressure instability characterized by chronic orthostatic hypotension (OH) and episodes of autonomic dysreflexia (AD).</p> <p>“This is an important milestone for ONWARD and the SCI community,” said Dave Marver, CEO of ONWARD. “Our ARC-IM System is designed to address several unmet needs, including blood pressure instability which is a major recovery target after spinal cord injury. With this IDE approval, we continue to advance our innovation pipeline and inspire realistic hope in restoring autonomic functions and independence after SCI and other movement disabilities.”</p> <p>Over 50% of people with SCI experience blood pressure instability, affecting nearly 350,000 people in the US and Europe. Blood pressure instability and persistent low blood pressure can threaten neurological recovery and negatively impact cardiovascular health and quality of life. The most frequent symptoms include dizziness, lightheadedness, blurred vision and fatigue.</p> <p>“Blood pressure instability, especially chronic low blood pressure, is one of the most hidden and unrecognized functional complications of spinal cord injury,” explains Dr. James Guest, neurosurgeon and Professor of Neurological Surgery at the University of Miami. “It leaves people feeling unwell and can significantly impact their overall quality of life. Blood pressure instability also increases the risk of cardiovascular disease, making addressing this unmet need critical for improving the long-term outcomes of SCI.”</p> <p>The ONWARD ARC-IM System is an implanted neuromodulation platform designed to deliver targeted and personalized spinal cord stimulation. It is the first neuroprosthetic system designed to manage blood pressure instability in people with SCI. It comprises the implanted ONWARD Neurostimulator (IPG) and the ARC-IM Thoracic Lead. The ARC-IM Thoracic Lead is optimized for surgical placement in a specific region of the thoracic spinal cord, called the “<em>Hemodynamic Hotspot</em>“. The location was first discovered by the Company’s research partners at the Swiss Federal Institute of Technology Lausanne (EPFL), Centre Hospitalier Universitaire Vaudois (CHUV), and the University of Calgary in a study published in <em>Nature</em> in January 2021.</p> <p>In December 2022, the Company announced positive top-line interim clinical results from its feasibility studies showing improved blood pressure regulation and improved hemodynamic stability after SCI. In addition to immediate and sustained improved blood pressure levels, participants taking anti-hypotension drugs prior to the study significantly reduced or discontinued their medication. Participants also reported improved general well-being and a reduction in orthostatic hypotension, including reduced dizziness and increased energy. Detailed interim results from these studies are expected to be published later this year.</p> <p>Managing blood pressure instability is among the major unmet needs for which the FDA has awarded the Company one of its 10 Breakthrough Device Designations. This award is reserved for novel, cutting-edge therapies addressing unmet needs and provides potential regulatory and reimbursement benefits.</p><p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/onward-medical-receives-fda-ide-approval-to-initiate-the-empower-bp-pivotal-study-with-the-arc-im-system/">ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>]]></content:encoded> </item> </channel></rss> If you would like to create a banner that links to this page (i.e. this validation result), do the following:
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