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  31. <title>KLIFO Receives Regulatory Approval for New State-of-the-Art Clinical Trial Supply Facility in Copenhagen</title>
  32. <link>https://journalforclinicalstudies.com/klifo-receives-regulatory-approval-for-new-state-of-the-art-clinical-trial-supply-facility-in-copenhagen/</link>
  33. <dc:creator><![CDATA[theArchitect]]></dc:creator>
  34. <pubDate>Thu, 30 Oct 2025 10:56:06 +0000</pubDate>
  35. <category><![CDATA[Regional News]]></category>
  36. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25225</guid>
  37.  
  38. <description><![CDATA[<p>Copenhagen,  Denmark  –  KLIFO,  Europe’s largest independent provider of Clinical Trial Supply (CTS) packaging and distribution services, has announced that its new 6,500 sqm (65,000  sq ft) Abildager facility, in Copenhagen, has received official Manufacturing and Importation Authorisation from the Danish Medicines Agency. This authorisation marks a significant milestone in KLIFO’s continued growth and its commitment [&#8230;]</p>
  39. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/klifo-receives-regulatory-approval-for-new-state-of-the-art-clinical-trial-supply-facility-in-copenhagen/">KLIFO Receives Regulatory Approval for New State-of-the-Art Clinical Trial Supply Facility in Copenhagen</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  40. ]]></description>
  41. <content:encoded><![CDATA[
  42. <p>Copenhagen,  Denmark  –  <a href="http://www.klifo.com/" target="_blank" rel="noopener">KLIFO</a>,  Europe’s largest independent provider of Clinical Trial Supply (CTS) packaging and distribution services, has announced that its new 6,500 sqm (65,000  sq ft) Abildager facility, in Copenhagen, has received official Manufacturing and Importation Authorisation from the Danish Medicines Agency.</p>
  43.  
  44.  
  45.  
  46. <p>This authorisation marks a significant milestone in KLIFO’s continued growth and its commitment to delivering innovative, flexible, and sustainable CTS solutions for the pharmaceutical and biotech industries.</p>
  47.  
  48.  
  49.  
  50. <p>The purpose-built facility is designed to meet the increasing demand for advanced clinical trial supply services and includes:</p>
  51.  
  52.  
  53.  
  54. <ul class="wp-block-list">
  55. <li>Significantly expanded capacity to support small-scale studies through to global Phase III and post-marketing trials </li>
  56.  
  57.  
  58.  
  59. <li>Comprehensive  temperature  management  from  controlled  room  temperature  to  -80°C for storage, primary and secondary packaging, and distribution</li>
  60.  
  61.  
  62.  
  63. <li>Low-light capabilities for light-sensitive products.</li>
  64. </ul>
  65.  
  66.  
  67.  
  68. <p>&#8220;Approval of our new facility represents a major step forward for KLIFO, and the site has already attracted significant interest from Nordic and international clients, reinforcing Copenhagen’s position as a leading life science hub in Europe,&#8221; said René Pedersen, CEO, KLIFO.</p>
  69.  
  70.  
  71.  
  72. <p>&#8220;We can now offer even greater capacity to meet complex clinical trial supply chain needs globally while maintaining our focus on quality, compliance, and flexibility.&#8221;</p>
  73.  
  74.  
  75.  
  76. <p>The new facility, combined with KLIFO’s experienced team, growing international reach, highly flexible solutions, and compliance with global requirements, means that&nbsp; KLIFO can accelerate project setup, reduce turnaround times, and minimise clinical supply chain issues.</p>
  77.  
  78.  
  79.  
  80. <p>About KLIFO&nbsp;</p>
  81.  
  82.  
  83.  
  84. <p><a href="http://klifo.com/" target="_blank" rel="noopener">KLIFO</a>&nbsp;is an integrated drug development clinical supply trial services provider and consultancy with more than 30 years of expertise in offering end-to-end solutions across all drug development areas through our Advisory and CTS business areas.&nbsp;</p>
  85.  
  86.  
  87.  
  88. <p>KLIFO CTS is the largest independent provider of end-to-end clinical trial supply services in Europe, offering proactive management throughout the clinical supply and logistics process.</p>
  89.  
  90.  
  91.  
  92. <p>KLIFO Advisory is an integrated North&nbsp; European drug development consultancy with significant experience in partnering with biotech, biopharma, and pharmaceutical companies, offering end-to-end solutions across all drug development areas.</p>
  93.  
  94.  
  95.  
  96. <p></p>
  97. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/klifo-receives-regulatory-approval-for-new-state-of-the-art-clinical-trial-supply-facility-in-copenhagen/">KLIFO Receives Regulatory Approval for New State-of-the-Art Clinical Trial Supply Facility in Copenhagen</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  98. ]]></content:encoded>
  99. </item>
  100. <item>
  101. <title>Certara Joins Veeva AI Partner Program to Simplify and Expedite Regulatory Submissions for Life Sciences</title>
  102. <link>https://journalforclinicalstudies.com/certara-joins-veeva-ai-partner-program-to-simplify-and-expedite-regulatory-submissions-for-life-sciences/</link>
  103. <dc:creator><![CDATA[theArchitect]]></dc:creator>
  104. <pubDate>Thu, 30 Oct 2025 10:51:59 +0000</pubDate>
  105. <category><![CDATA[Regional News]]></category>
  106. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25223</guid>
  107.  
  108. <description><![CDATA[<p>RADNOR, PA– Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced it has joined the Veeva AI Partner Program. The planned integration by Certara with Veeva RIM aims to significantly enhance document automation by simplifying digital data flows between existing content stored in Veeva RIM and CoAuthor’s generative AI technology. Rapidly changing [&#8230;]</p>
  109. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/certara-joins-veeva-ai-partner-program-to-simplify-and-expedite-regulatory-submissions-for-life-sciences/">Certara Joins Veeva AI Partner Program to Simplify and Expedite Regulatory Submissions for Life Sciences</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  110. ]]></description>
  111. <content:encoded><![CDATA[
  112. <p><strong>RADNOR, PA– </strong>Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced it has joined the Veeva AI Partner Program. The planned integration by Certara with Veeva RIM aims to significantly enhance document automation by simplifying digital data flows between existing content stored in Veeva RIM and CoAuthor’s generative AI technology.</p>
  113.  
  114.  
  115.  
  116. <p>Rapidly changing study data often poses a significant roadblock for regulatory writers – from preparing first drafts to submission ready documents. This scenario costs the industry valuable time and creates tension between writers and the individuals in charge of preparing data for submission. In addition, the application of generative AI requires access to relevant data in near real time to provide acceptable results. Providing seamless access to content between data preparer, technology, and writer is critical to meeting shrinking submission deadlines.</p>
  117.  
  118.  
  119.  
  120. <p>By joining the Veeva AI Partner Program, Certara will allow its customers using CoAuthor and Veeva RIM to seamlessly work in both systems. Using CoAuthor, regulatory writers can directly link their source files from Veeva RIM, eliminating the need to import them into CoAuthor. This integration will streamline the initial content sourcing process, improving collaboration between data providers and regulatory writers throughout the document draft life cycle.</p>
  121.  
  122.  
  123.  
  124. <p>“Medical writers are embracing generative AI like CoAuthor to cut first-draft time by 30%. The integration with Veeva Rim allows us to deliver a seamless, end-to-end regulatory writing experience that drives greater value,” said Christopher Bouton, Chief Technology Officer at Certara.</p>
  125.  
  126.  
  127.  
  128. <p>To learn more, visit the&nbsp;<a href="https://www.certara.com/coauthor/" target="_blank" rel="noopener">CoAuthor webpage</a>.</p>
  129.  
  130.  
  131.  
  132. <p><strong></strong><strong>About Certara</strong></p>
  133.  
  134.  
  135.  
  136. <p><a href="https://www.certara.com/" target="_blank" rel="noopener">Certara</a>&nbsp;accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Learn more at certara.com.</p>
  137.  
  138.  
  139.  
  140. <p><strong></strong><strong>Certara Contact:</strong></p>
  141.  
  142.  
  143.  
  144. <p>Sheila Rocchio <a href="mailto:Sheila.rocchio@certara.com">Sheila.Rocchio@certara.com</a></p>
  145. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/certara-joins-veeva-ai-partner-program-to-simplify-and-expedite-regulatory-submissions-for-life-sciences/">Certara Joins Veeva AI Partner Program to Simplify and Expedite Regulatory Submissions for Life Sciences</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  146. ]]></content:encoded>
  147. </item>
  148. <item>
  149. <title>DNAnexus Honoured with Frost &#038; Sullivan’s 2025 Technology Innovation Leadership Award</title>
  150. <link>https://journalforclinicalstudies.com/dnanexus-honoured-with-frost-sullivans-2025-technology-innovation-leadership-award/</link>
  151. <dc:creator><![CDATA[theArchitect]]></dc:creator>
  152. <pubDate>Thu, 30 Oct 2025 10:48:32 +0000</pubDate>
  153. <category><![CDATA[Regional News]]></category>
  154. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25221</guid>
  155.  
  156. <description><![CDATA[<p>MOUNTAIN VIEW, Calif. — DNAnexus, Inc., global provider of the leading enterprise platform for precision health data, today announced it has been recognized by Frost &#38; Sullivan with the prestigious 2025 Technology Innovation Leadership Award for excellence in best practices within the global precision health informatics industry. This accolade highlights DNAnexus’ groundbreaking contributions to integrating [&#8230;]</p>
  157. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/dnanexus-honoured-with-frost-sullivans-2025-technology-innovation-leadership-award/">DNAnexus Honoured with Frost &amp; Sullivan’s 2025 Technology Innovation Leadership Award</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  158. ]]></description>
  159. <content:encoded><![CDATA[
  160. <p><strong>MOUNTAIN VIEW, Calif. — </strong>DNAnexus, Inc., global provider of the leading enterprise platform for precision health data, today announced it has been recognized by Frost &amp; Sullivan with the prestigious 2025 Technology Innovation Leadership Award for excellence in best practices within the global precision health informatics industry. This accolade highlights DNAnexus’ groundbreaking contributions to integrating and synchronizing diverse clinical, multi-omics, and real-world data to accelerate innovation in life sciences.</p>
  161.  
  162.  
  163.  
  164. <p>Frost &amp; Sullivan Best Practices awards recognize companies each year in various regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices.&nbsp;</p>
  165.  
  166.  
  167.  
  168. <p>“Being recognized by Frost &amp; Sullivan validates our efforts to lead the precision health industry with innovation and impact,” said Thomas Laur, CEO, DNAnexus. “DNAnexus has established the market standard for multi-omics advanced analytics, and we will continue to prioritize expertise, collaboration, and speed as the market becomes increasingly reliant on our platform to deliver actionable insights without compromising compliance, control or security.”&nbsp;</p>
  169.  
  170.  
  171.  
  172. <p>Frost &amp; Sullivan’s rigorous evaluation process identified DNAnexus as a technology leader for its ability to make complex health data accessible, actionable, and secure. The company’s enterprise platform empowers pharmaceutical companies, biotech firms, healthcare providers, clinical diagnostics, and academic researchers to collaborate, innovate and accelerate the development of personalized treatments through scientific discovery.&nbsp;</p>
  173.  
  174.  
  175.  
  176. <p>“Since 2009, DNAnexus has demonstrated exceptional staying power in a space where many competitors failed to gain traction,” said Surbhi Gupta, Industry Principal at Frost &amp; Sullivan. “A key reason for this is DNAnexus’ combination of scientific fluency, user-centered design, and strategic responsiveness that defines its brand and underpins its expansion potential. This ensures long-term momentum in an increasingly complex and competitive landscape and positions DNAnexus as a cornerstone of the precision health informatics ecosystem.”</p>
  177.  
  178.  
  179.  
  180. <p>To access the report detailing Frost and Sullivan’s evaluation of DNAnexus, click <a href="https://www.dnanexus.com/resources/report/frost-sullivan-2025-industry-report-informatics" target="_blank" rel="noopener">here</a>. For more information about DNAnexus and its award-winning platform, visit <a href="https://www.dnanexus.com/" target="_blank" rel="noopener">https://www.dnanexus.com/</a>.</p>
  181.  
  182.  
  183.  
  184. <p><strong>About DNAnexus</strong></p>
  185.  
  186.  
  187.  
  188. <p>DNAnexus, the enterprise platform for precision health data, is on a mission to accelerate the development, approval, and delivery of personalized treatments. Building on more than 15 years of bioinformatics innovation and genomics expertise, DNAnexus powers a connected data ecosystem trusted by the world’s precision health leaders. This flexible ecosystem makes omics and real-world data accessible, actionable, and secure while unlocking insights that improve patient lives. For more information, visit <a href="http://www.dnanexus.com/" target="_blank" rel="noopener">www.dnanexus.com</a> or follow @DNAnexus on social media.</p>
  189.  
  190.  
  191.  
  192. <p><strong>About Frost &amp; Sullivan</strong></p>
  193.  
  194.  
  195.  
  196. <p>Frost &amp; Sullivan, the Growth Partnership Company, collaborates with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today&#8217;s market participants. For more than 50 years, Frost &amp; Sullivan has been developing growth strategies for the global 1000, emerging businesses, the public sector, and the investment community.</p>
  197.  
  198.  
  199.  
  200. <p><strong>Media Contact:</strong></p>
  201.  
  202.  
  203.  
  204. <p>Meredith Schwenk<a href="mailto:press@dnanexus.com">press@dnanexus.com</a></p>
  205. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/dnanexus-honoured-with-frost-sullivans-2025-technology-innovation-leadership-award/">DNAnexus Honoured with Frost &amp; Sullivan’s 2025 Technology Innovation Leadership Award</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  206. ]]></content:encoded>
  207. </item>
  208. <item>
  209. <title>Sharp Services Invests $100 million in US and European facilities to Increase Capacity and Service Offerings</title>
  210. <link>https://journalforclinicalstudies.com/sharp-services-invests-100-million-in-us-and-european-facilities-to-increase-capacity-and-service-offerings/</link>
  211. <dc:creator><![CDATA[theArchitect]]></dc:creator>
  212. <pubDate>Thu, 30 Oct 2025 10:46:36 +0000</pubDate>
  213. <category><![CDATA[Regional News]]></category>
  214. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25219</guid>
  215.  
  216. <description><![CDATA[<p>Sharp Services, a leader in pharmaceutical packaging, clinical trial services &#38; sterile manufacturing has announced a $100 million investment across its global facility network to address increasing market demand for established and new medicines.  With six GMP facilities in the US and three in Europe, Sharp is strategically positioned to provide clinical and commercial solutions worldwide. [&#8230;]</p>
  217. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/sharp-services-invests-100-million-in-us-and-european-facilities-to-increase-capacity-and-service-offerings/">Sharp Services Invests $100 million in US and European facilities to Increase Capacity and Service Offerings</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  218. ]]></description>
  219. <content:encoded><![CDATA[
  220. <p><a href="https://www.sharpservices.com/" target="_blank" rel="noopener">Sharp Services,</a> a leader in pharmaceutical packaging, clinical trial services &amp; sterile manufacturing has announced a $100 million investment across its global facility network to address increasing market demand for established and new medicines. </p>
  221.  
  222.  
  223.  
  224. <p>With six GMP facilities in the US and three in Europe, Sharp is strategically positioned to provide clinical and commercial solutions worldwide. Expanding its services across its facility network will further extend the company’s capabilities to meet the needs of clients.&nbsp;</p>
  225.  
  226.  
  227.  
  228. <p>Kevin Orfan, President &amp; CEO of Sharp, commented: “These multi-site investments at Sharp reflect our ongoing commitment to support the evolving needs of our pharma and biopharma clients in each of our core businesses. We are strengthening our service offerings across our entire network to provide more capacity, new capabilities and greater efficiency thereby reinforcing our role as a trusted and experienced partner to our clients as we help them bring important medicines to patients around the world.&#8221;</p>
  229.  
  230.  
  231.  
  232. <p>The investment in new injectable capacity in the US and Europe is in response to strong market demand for assembly and packaging of pre-filled syringes and autoinjectors, along with ancillary services. Sharp’s Netherlands facility is increasing GMP production capacity to accommodate new vial labeling, syringe assembly and injectables packaging, which is due to come online in 2026.&nbsp; In Belgium, Sharp has begun a significant warehouse expansion which will include additional cold-chain and ambient storage, and is building out a new syringe blistering production suite.</p>
  233.  
  234.  
  235.  
  236. <p>As part of this global investment strategy, Sharp’s Allentown campus will add a new pre-filled syringe assembly, labeling and packaging line, a vial labeler and high-speed cartoner, a mid-speed bottling and packaging line for OSD products, and automated pouch filling lines for powder and OSD products. This new equipment will add capacity to support exiting products as well as provide capacity for new opportunities.&nbsp;&nbsp;</p>
  237.  
  238.  
  239.  
  240. <p>These investments at Allentown complement the recent $20 million investment announcement for&nbsp;<a href="https://www.sharpservices.com/about-us/news/sharp-invests-20-million-in-autoinjector-pen-assembly-lines-to-meet-rising-demand-for-injectables/" target="_blank" rel="noopener">autoinjector and pen assembly services at Macungie</a>. The plan includes installation of two autoinjector and pen assembly, labeling and packaging lines at its facility in Macungie, US.&nbsp;&nbsp;</p>
  241.  
  242.  
  243.  
  244. <p>Sharp’s Bethlehem, PA, site which offers clinical services from preclinical through to commercial has commenced the installation of a 2-8 C production room with refrigerator and -15 C to -25 C walk-in freezer, two new capsule filling machines and an additional blister line to package OSD products. These new clinical and commercial capabilities will be operational at the site by end of 2025.</p>
  245.  
  246.  
  247.  
  248. <p>Sharp has also committed $28 million to significantly increase capacity at its sterile manufacturing facility in Lee, MA. The investment will support the installation of a fourth state-of-the-art isolator-based sterile filling line with lyophilization and several related infrastructural upgrades.</p>
  249.  
  250.  
  251.  
  252. <p>Discover more about Sharp’s services&nbsp;<a href="https://www.sharpservices.com/connect/contact/" target="_blank" rel="noopener">here.</a>&nbsp;</p>
  253. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/sharp-services-invests-100-million-in-us-and-european-facilities-to-increase-capacity-and-service-offerings/">Sharp Services Invests $100 million in US and European facilities to Increase Capacity and Service Offerings</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  254. ]]></content:encoded>
  255. </item>
  256. <item>
  257. <title>Ansa Biotechnologies Redefines What’s Possible in DNA Synthesis with 50 kb Sequence-Perfect Clonal Product</title>
  258. <link>https://journalforclinicalstudies.com/ansa-biotechnologies-redefines-whats-possible-in-dna-synthesis-with-50-kb-sequence-perfect-clonal-product/</link>
  259. <dc:creator><![CDATA[theArchitect]]></dc:creator>
  260. <pubDate>Thu, 30 Oct 2025 10:43:33 +0000</pubDate>
  261. <category><![CDATA[Regional News]]></category>
  262. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25217</guid>
  263.  
  264. <description><![CDATA[<p>EMERYVILLE, Calif. Ansa Biotechnologies, the trusted partner for DNA synthesis, today announced the global launch of its 50 kilobase (kb) Clonal DNA product, the longest sequence-perfect synthetic DNA commercially available. Powered by the company’s proprietary enzymatic synthesis platform and backed by the unique Ansa On-Time Guarantee, the new product allows scientists to design and obtain complete, [&#8230;]</p>
  265. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/ansa-biotechnologies-redefines-whats-possible-in-dna-synthesis-with-50-kb-sequence-perfect-clonal-product/">Ansa Biotechnologies Redefines What’s Possible in DNA Synthesis with 50 kb Sequence-Perfect Clonal Product</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  266. ]]></description>
  267. <content:encoded><![CDATA[
  268. <p><strong>EMERYVILLE, Calif.</strong> Ansa Biotechnologies, the trusted partner for DNA synthesis, today announced the global launch of its <a href="http://ansabio.com/product/50kb" target="_blank" rel="noopener">50 kilobase (kb) Clonal DNA product</a>, the longest sequence-perfect synthetic DNA commercially available. Powered by the company’s proprietary enzymatic synthesis platform and backed by the unique Ansa On-Time Guarantee, the new product allows scientists to design and obtain complete, error-free DNA constructs in 25 days or less, eliminating the compromises that have defined gene synthesis for decades.</p>
  269.  
  270.  
  271.  
  272. <p>Traditional chemical DNA synthesis rarely produces sequences beyond 10 kb, forcing researchers to assemble fragments manually — a process prone to errors and delays. Ansa’s enzymatic platform eliminates these barriers, enabling direct synthesis of long, complex sequences with unmatched precision and sustainability. Every construct undergoes rigorous verification with long-read sequencing and proprietary informatics quality control to ensure accuracy. The Ansa On-Time Guarantee gives customers confidence that they will receive their complete orders on time, or they will get their DNA for free.</p>
  273.  
  274.  
  275.  
  276. <p>“Ansa has provided us with extremely long and complex constructs we couldn&#8217;t get anywhere else,” said Molly Gasperini, PhD, Associate Director of Genome Engineering at the Allen Institute’s Seattle Hub for Synthetic Biology. “For these types of sequences, as long as 50 kb, other providers often reject or quote an extremely long ETA. Without Ansa, we couldn&#8217;t obtain them so efficiently, affordably, and reliably — or at all!”</p>
  277.  
  278.  
  279.  
  280. <p>The new Ansa product launch follows a successful&nbsp;<a href="https://www.businesswire.com/news/home/20250506331443/en/Ansa-Biotechnologies-Breaks-Traditional-Synthetic-DNA-Length-Barriers-and-Redefines-Future-of-Life-Science-Research" target="_blank" rel="noopener">early access program</a>&nbsp;involving more than 20 leading institutions. Participants used Ansa’s long synthetic DNA to overcome traditional synthesis barriers and to accelerate breakthroughs in synthetic genomics, metabolic engineering, agriculture, and cell and gene therapy development. The ultra-long, fully sequence-verified DNA constructs are now available to customers around the world for as little as&nbsp;28 cents per base pair with&nbsp;turnaround times less than 25 business days. Ansa offers a fully transparent pricing strategy in which the average cost per base pair decreases as the sequence length increases.&nbsp;</p>
  281.  
  282.  
  283.  
  284. <p>“We are very excited about the Ansa technology, which has derisked timelines for creating our TARGATT<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;" /> donor plasmids,&#8221; said Dolores Baksh, PhD, CEO of Applied StemCell. &#8220;Ansa&#8217;s large DNA synthesis capabilities align well with the strength of our TARGATT<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;" /> technology, which efficiently and site-specifically inserts multi-protein constructs into the H11 safe harbor site in mammalian cells. We find that Ansa can even do difficult and complex sequences that can be challenging to clone or synthesize, and the inserted DNA always expresses well.”</p>
  285.  
  286.  
  287.  
  288. <p>“For years, scientists have been limited by what they could build, not what they could imagine,” said Jason T. Gammack, Chief Executive Officer of Ansa Biotechnologies. “By delivering 50 kb sequence-perfect DNA in weeks, and guaranteeing it on time, we’re unlocking the next era of biological design, where imagination, not manufacturing, sets the limits.”</p>
  289.  
  290.  
  291.  
  292. <p>The 50 kb launch builds on Ansa’s rapid commercial growth and recent&nbsp;<a href="https://ansabio.com/news-events/pr/ansa-biotechnologies-secures-54-4-million-in-series-b-financing/" target="_blank" rel="noopener">$54.5 million Series B financing</a>, reinforcing the company’s mission to accelerate discovery through next-generation DNA synthesis.<em>&nbsp;</em>Exclusively manufactured in the United States, Ansa’s DNA products integrate seamlessly into existing workflows and are designed to empower the next wave of biological discovery. The company follows a stringent biosecurity framework and fully complies with all requirements outlined in the U.S. Office of Science and Technology Policy Framework for Nucleic Acid Synthesis Screening. For more information about Ansa’s products, please visit&nbsp;<a href="http://www.ansabio.com/products" target="_blank" rel="noopener">www.ansabio.com/products</a>.<em></em></p>
  293.  
  294.  
  295.  
  296. <p><strong>About Ansa Biotechnologies</strong></p>
  297.  
  298.  
  299.  
  300. <p>Ansa Biotechnologies is redefining DNA synthesis with a bold commitment to quality, customer satisfaction, and success. The Ansa On-Time Guarantee is simple and straightforward: your complete order on time or it’s free. This unprecedented level of service reliability and predictability is made possible by Ansa’s dedicated team of experts and proprietary enzymatic synthesis platform, which can rapidly and accurately produce even the highly complex DNA elements that stymie legacy approaches. Products are delivered as sequence-perfect clonal DNA or sequence-verified linear double-stranded DNA fragments. Headquartered in Emeryville, Calif., Ansa is empowering a global community of scientists to accelerate breakthroughs in healthcare, life sciences, and other industries powered by synthetic DNA.&nbsp;Discover more at&nbsp;<a href="http://www.ansabio.com/" target="_blank" rel="noopener">ansabio.com</a>&nbsp;or follow the company on&nbsp;<a href="https://x.com/AnsaBio" target="_blank">X</a>,&nbsp;<a href="https://bsky.app/profile/ansabio.bsky.social" target="_blank" rel="noopener">Bluesky</a>, and&nbsp;<a href="https://www.linkedin.com/company/ansabio/" target="_blank" rel="noopener">LinkedIn</a>.</p>
  301. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/ansa-biotechnologies-redefines-whats-possible-in-dna-synthesis-with-50-kb-sequence-perfect-clonal-product/">Ansa Biotechnologies Redefines What’s Possible in DNA Synthesis with 50 kb Sequence-Perfect Clonal Product</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  302. ]]></content:encoded>
  303. </item>
  304. <item>
  305. <title>AI in Clinical Trial Recruitment: Proceed with Cautious Optimism</title>
  306. <link>https://journalforclinicalstudies.com/ai-in-clinical-trial-recruitment-proceed-with-cautious-optimism/</link>
  307. <dc:creator><![CDATA[theArchitect]]></dc:creator>
  308. <pubDate>Fri, 24 Oct 2025 10:20:38 +0000</pubDate>
  309. <category><![CDATA[Current features]]></category>
  310. <category><![CDATA[Volume 17 Issue 3]]></category>
  311. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25212</guid>
  312.  
  313. <description><![CDATA[<p>Artificial Intelligence (AI) is rapidly reshaping the landscape of clinical research, offering transformative solutions to longstanding challenges in trial design, execution and data management. As of 2025, AI is no longer a futuristic concept; it is a practical tool driving efficiency, precision and innovation across the clinical trial ecosystem. But what does AI mean in [&#8230;]</p>
  314. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/ai-in-clinical-trial-recruitment-proceed-with-cautious-optimism/">AI in Clinical Trial Recruitment: Proceed with Cautious Optimism</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  315. ]]></description>
  316. <content:encoded><![CDATA[
  317. <p>Artificial Intelligence (AI) is rapidly reshaping the landscape of clinical research, offering transformative solutions to longstanding challenges in trial design, execution and data management. As of 2025, AI is no longer a futuristic concept; it is a practical tool driving efficiency, precision and innovation across the clinical trial ecosystem. But what does AI mean in the context of practical applications for day-to-day clinical development activities? And does its potential have any limits?</p>
  318.  
  319.  
  320.  
  321. <p>Patient recruitment remains one of the most persistent challenges in clinical research, with up to 80% of trials failing to meet enrolment timelines and nearly one-third of Phase III trials being terminated due to insufficient accrual. In this context, AI offers a compelling opportunity to reimagine how patients are identified, engaged and retained. Yet, as with any powerful tool, its use must be tempered with ethical foresight and operational realism. This editorial explores the promise, limitations and future direction of AI in clinical trial recruitment.</p>
  322.  
  323.  
  324.  
  325. <p>The Evolution of Recruitment Challenges Historically, patient recruitment has been a consistent operational challenge in clinical trials. Traditional methods including physician referrals, site databases and advertising campaigns, often resulted in slow enrolment, high dropout rates and underrepresentation of diverse populations. Despite incremental improvements, recruitment delays continue to cost sponsors millions annually and jeopardise study timelines. These persistent challenges underscore the need for innovative, data-driven approaches to recruitment, where AI, in particular, is emerging as a transformative force in this space.</p>
  326. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/ai-in-clinical-trial-recruitment-proceed-with-cautious-optimism/">AI in Clinical Trial Recruitment: Proceed with Cautious Optimism</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  327. ]]></content:encoded>
  328. </item>
  329. <item>
  330. <title>Clinical Trials: A Logistical Nightmare?</title>
  331. <link>https://journalforclinicalstudies.com/clinical-trials-a-logistical-nightmare/</link>
  332. <dc:creator><![CDATA[theArchitect]]></dc:creator>
  333. <pubDate>Thu, 23 Oct 2025 12:24:52 +0000</pubDate>
  334. <category><![CDATA[Current features]]></category>
  335. <category><![CDATA[Volume 17 Issue 3]]></category>
  336. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25173</guid>
  337.  
  338. <description><![CDATA[<p>For clinical trial managers, the list of planning variables can seem endless. Cohort selection and patient recruitment, regulatory engagement and compliance, data management and security; each aspect presents unique challenges that could result in trial failure if not well managed. Logistics is another potential headache, with trials requiring global transport of medicines, hazardous materials, patient [&#8230;]</p>
  339. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/clinical-trials-a-logistical-nightmare/">Clinical Trials: A Logistical Nightmare?</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  340. ]]></description>
  341. <content:encoded><![CDATA[
  342. <p>For clinical trial managers, the list of planning variables can seem endless. Cohort selection and patient recruitment, regulatory engagement and compliance, data management and security; each aspect presents unique challenges that could result in trial failure if not well managed. Logistics is another potential headache, with trials requiring global transport of medicines, hazardous materials, patient cells and samples. </p>
  343.  
  344.  
  345.  
  346. <p>Clinical trials are one of the most demanding areas within life science logistics, requiring efficient delivery of novel, sensitive medicines all over the world. These trials often involve numerous cross-border shipments with associated customs requirements. Whatever the shipment type, it is crucial to protect the integrity and quality of the medicine or sample, to ensure that the clinical trial is safe and that data generated from the trial is accurate. </p>
  347.  
  348.  
  349.  
  350. <p>So, is clinical trial logistics as nightmarish as it sounds or could it actually present an opportunity for the industry?</p>
  351. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/clinical-trials-a-logistical-nightmare/">Clinical Trials: A Logistical Nightmare?</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  352. ]]></content:encoded>
  353. </item>
  354. <item>
  355. <title>Beyond Manufacturing: Strategic Clinical Supply Management for Global Trial Success</title>
  356. <link>https://journalforclinicalstudies.com/beyond-manufacturing-strategic-clinical-supply-management-for-global-trial-success/</link>
  357. <dc:creator><![CDATA[theArchitect]]></dc:creator>
  358. <pubDate>Thu, 23 Oct 2025 12:24:00 +0000</pubDate>
  359. <category><![CDATA[Current features]]></category>
  360. <category><![CDATA[Volume 17 Issue 3]]></category>
  361. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25171</guid>
  362.  
  363. <description><![CDATA[<p>Clinical trials are the critical stages in which scientific innovation is tested and validated in patients, collecting data that will transform experimental therapies into approved treatments. While therapeutic efficacy remains the ultimate driver, the practical execution of packaging, labelling and distribution determine whether an investigational therapy reaches trial participants on time, in stable condition and [&#8230;]</p>
  364. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/beyond-manufacturing-strategic-clinical-supply-management-for-global-trial-success/">Beyond Manufacturing: Strategic Clinical Supply Management for Global Trial Success</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  365. ]]></description>
  366. <content:encoded><![CDATA[
  367. <p>Clinical trials are the critical stages in which scientific innovation is tested and validated in patients, collecting data that will transform experimental therapies into approved treatments. While therapeutic efficacy remains the ultimate driver, the practical execution of packaging, labelling and distribution determine whether an investigational therapy reaches trial participants on time, in stable condition and in full regulatory compliance. Selecting the right partner to execute these activities is not simply a procurement exercise. It is a strategic decision that directly influences patient safety, cost control and trial continuity. </p>
  368.  
  369.  
  370.  
  371. <p>The critical clinical trials needed to establish safety and efficacy as well as providing registration data, are typically large, global and complex, in design. This complexity heightens operational risk from supply chain disruptions to regulatory misalignment. The ability to anticipate and manage these risks is now a differentiator between trials that run smoothly and those that stall.</p>
  372. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/beyond-manufacturing-strategic-clinical-supply-management-for-global-trial-success/">Beyond Manufacturing: Strategic Clinical Supply Management for Global Trial Success</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  373. ]]></content:encoded>
  374. </item>
  375. <item>
  376. <title>Harnessing Transformative Data Visualisation for Clinical Research: From Insights to Action</title>
  377. <link>https://journalforclinicalstudies.com/harnessing-transformative-data-visualisation-for-clinical-research-from-insights-to-action/</link>
  378. <dc:creator><![CDATA[theArchitect]]></dc:creator>
  379. <pubDate>Thu, 23 Oct 2025 12:23:15 +0000</pubDate>
  380. <category><![CDATA[Current features]]></category>
  381. <category><![CDATA[Volume 17 Issue 3]]></category>
  382. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25169</guid>
  383.  
  384. <description><![CDATA[<p>In the complicated realm of clinical research, data abounds – yet, in its raw form, this data remains scattered, isolated and often difficult to use. The true power of clinical research lies not in the sheer volume of data amassed, but in the clarity and actionable insight that can be extracted from it. The act [&#8230;]</p>
  385. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/harnessing-transformative-data-visualisation-for-clinical-research-from-insights-to-action/">Harnessing Transformative Data Visualisation for Clinical Research: From Insights to Action</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  386. ]]></description>
  387. <content:encoded><![CDATA[
  388. <p>In the complicated realm of clinical research, data abounds – yet, in its raw form, this data remains scattered, isolated and often difficult to use. The true power of clinical research lies not in the sheer volume of data amassed, but in the clarity and actionable insight that can be extracted from it. The act of transforming raw numbers into meaningful information is akin to assembling an immense puzzle, where each piece represents patient data, outcomes, disease patterns and operational metrics. Only when these pieces are connected does a coherent picture emerge – one that can guide decision-making and drive innovation. This is critical as we keep in mind more than the day-to-day, but the bigger picture of the patients we serve – be those strangers, friends, neighbours, or ourselves to ensure we ultimately improve patient outcomes. This article explores the pivotal role of data visualisation in clinical research, advocating for a strategic, people-centric approach that translates insights into decisive action.</p>
  389.  
  390.  
  391.  
  392. <p>The Puzzle of Clinical Data The analogy of clinical research as a puzzle is more than metaphor; it is a defining challenge across the industry. Every clinical trial generates thousands of data points – demographics, lab results, safety signals, efficacy outcomes, operational timelines. When these data points remain unintegrated, the potential for insight remains dormant. Data visualisation is the act of fitting these pieces together, revealing patterns, trends and stories that would remain invisible in the raw, numeric form. Without visualisation, clinical data is fragmented and its true value – its ability to inform and transform – is left unrealised.</p>
  393. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/harnessing-transformative-data-visualisation-for-clinical-research-from-insights-to-action/">Harnessing Transformative Data Visualisation for Clinical Research: From Insights to Action</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  394. ]]></content:encoded>
  395. </item>
  396. <item>
  397. <title>Reimagining Clinical Trial Management: AI as the Virtual Team Member</title>
  398. <link>https://journalforclinicalstudies.com/reimagining-clinical-trial-management-ai-as-the-virtual-team-member/</link>
  399. <dc:creator><![CDATA[theArchitect]]></dc:creator>
  400. <pubDate>Thu, 23 Oct 2025 12:22:06 +0000</pubDate>
  401. <category><![CDATA[Current features]]></category>
  402. <category><![CDATA[Volume 17 Issue 3]]></category>
  403. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25167</guid>
  404.  
  405. <description><![CDATA[<p>Currently, clinical trials face challenges such as complex protocols, extended timelines, substantial costs and increasing regulatory requirements. As these trials become increasingly complex, costly and subject to stricter regulations, sponsors are exploring innovative methods to enhance trial planning, execution and oversight. Historically, the management of clinical trials has relied heavily on labour-intensive procedures, including the [&#8230;]</p>
  406. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/reimagining-clinical-trial-management-ai-as-the-virtual-team-member/">Reimagining Clinical Trial Management: AI as the Virtual Team Member</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  407. ]]></description>
  408. <content:encoded><![CDATA[
  409. <p>Currently, clinical trials face challenges such as complex protocols, extended timelines, substantial costs and increasing regulatory requirements. As these trials become increasingly complex, costly and subject to stricter regulations, sponsors are exploring innovative methods to enhance trial planning, execution and oversight. Historically, the management of clinical trials has relied heavily on labour-intensive procedures, including the use of spreadsheets, reports and periodic status meetings, as well as fragmented technological systems. With the rising complexity of clinical trials, the workload on clinical project teams correspondingly increases. Furthermore, the clinical research ecosystem is under increasing pressure to conduct trials more efficiently and cost-effectively.</p>
  410.  
  411.  
  412.  
  413. <p>The transition towards digital transformation presents an opportunity to reconsider methodologies for conducting trials through the integration of Artificial Intelligence (AI)-driven, automated and data-centric systems. Conventional manual procedures are increasingly insufficient in maintaining efficiency and cost-effectiveness. Artificial Intelligence (AI) is progressing beyond just being a tool for data analysis and forecasting, emerging as an active participant within the clinical project team. AI is no longer a distant concept; it is becoming a virtual team member capable of enhancing or even autonomously executing a broad spectrum of roles traditionally carried out by members of the clinical operations team. By employing machine learning, natural language processing (NLP) and real-time analytics, AI enhances essential functions such as patient recruitment, site selection, data monitoring, risk assessment and protocol adherence. It facilitates expedited decision-making, predictive risk management and increased operational efficiency. As the complexity and scale of clinical trials expand, AI offers an intelligent, scalable solution to streamline workflows, improve data quality and accelerate timelines, redefining the future landscape of the drug development process.</p>
  414. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/reimagining-clinical-trial-management-ai-as-the-virtual-team-member/">Reimagining Clinical Trial Management: AI as the Virtual Team Member</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  415. ]]></content:encoded>
  416. </item>
  417. </channel>
  418. </rss>
  419.  

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