Latest news with #eClinical
Miami Herald
5 days ago
- Business
- Miami Herald
Yunu Unveils Next-Gen Trial Imaging with New eCRF Builder, Custom Dashboards & Universal Integration Portal
CARY, NC / ACCESS Newswire / May 29, 2025 / Yunu, the creator and leader in cloud-native imaging workflows for clinical trials, today announced a major new software release that empowers pharma sponsors to configure studies in minutes, enforce consistency, and deliver imaging data straight into their primary data systems - while simplifying work for site staff. Yunu's unified cloud-SaaS platform powers end-to-end imaging workflows for thousands of clinical trials worldwide. From de-identification and site assessments to blinded reads with adjudication and real-time data delivery to sponsors, Yunu harmonizes multi-site trials, reduces complexity, and accelerates timelines, thereby reducing costs for both sponsors and sites. Expanding these capabilities, Yunu's new eCRF builder, enhanced sponsor dashboards, and native integration portal deliver a new realm of possibilities for trial sponsors who have previously been limited to inefficient and expensive manual workflows, long timelines, and disconnected data. "To deliver better outcomes for patients, we have to be more protective of the imaging data that will define tomorrow's treatments," said Jeff Sorenson, CEO & Co-founder of Yunu. "With our new eCRF builder, intuitive dashboards, and seamless integration portal, sponsors gain full control over imaging endpoints - while sites benefit from a simpler, guided workflow and access to expert reading resources." KEY SPONSOR BENEFITS Rapid Customization of Imaging eCRFsProvides flexible capture of trial-specific data from directly within the QC and reading process, easily defined during the 30-minute study setup process, with no coding or Data, Custom Dashboards1,300+ standard data elements deliver unmatched context, traceability, and value with active monitoring of imaging schedules, scan availability, read status, and response rates across any combination of trials, therapeutic areas, participating sites, or Data IntegrationThe Yunu integration portal supports user-defined and configured APIs, allowing for easy integration between other eClinical and data systems and your Yunu imaging source of truth. Imaging eCRF outputs and all other captured data are sent directly from Yunu into your clinical data warehouse or EDC system in real time - eliminating manual handoffs and file transfers. SITE ADVANTAGES Guided, Error-Free WorkflowsRadiologists, whether onsite or remote, follow the same step-by-step process, delivering complete, standardized, harmonized, protocol-conformant imaging endpoints that eliminate cumbersome and error-prone manual paper forms or Read TurnaroundBy streamlining end-to-end imaging workflows and data management tasks, Yunu frees up site staff to focus on patient care rather than paperwork. All new features are available immediately to every Yunu customer and may be activated on any new or ongoing trial. Yunu will be exhibiting at the American Society of Clinical Oncology's (ASCO) Annual Meeting this weekend from Saturday, May 31st - Monday, June 2nd, at Booth #10080. Visit Yunu at ASCO or connect with the team by visiting ABOUT YUNUYunu enables life sciences organizations to streamline imaging workflows, improve accuracy, and accelerate timelines. Yunu's platform supports clinical trials across various therapeutic areas, offering scalability and flexibility for organizations of all sizes. For more information, visit and follow us on LinkedIn or X @Yunu_Inc.
Yahoo
13-05-2025
- Business
- Yahoo
AO Foundation Selects Trial Interactive to Digitize Clinical Trial Operations
NEW YORK and DAVOS, Switzerland, May 13, 2025 (GLOBE NEWSWIRE) -- TransPerfect Life Sciences, a leading provider of content solutions and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced that the AO Foundation selected its award-winning Trial Interactive platform, including eISF, Study Collaborate, and eTMF, to support the foundation's upcoming clinical trials. Based in Davos, Switzerland, the AO Foundation is a not-for-profit organization that focuses on improving the treatment of musculoskeletal disorders and trauma. By integrating Trial Interactive's eClinical solutions, the AO Foundation is taking a significant step toward supporting its project managers and data scientists with a fully digital and inspection-ready infrastructure. "Our collaboration with the AO Foundation reflects a shared commitment to advancing healthcare through innovation," commented Michael Smyth, Division President of Trial Interactive. "By transitioning from legacy systems and paper-based processes to our robust and interoperable eClinical platform, the AO Foundation is well-positioned to achieve operational excellence and regulatory compliance." 'Trial Interactive's expertise is an excellent match to our engagement in clinical trials,' remarked Dr. Katrin Simioni, Deputy Head of Clinical Operations at the AO Foundation. 'Their platforms offer all features we need to improve our workflows, ensuring high-quality studies for our mission to improve patient treatment.' About the AO Foundation The AO Foundation is a medically guided, not-for-profit organization, a global network of surgeons, and the world's leading education, innovation, and research organization specializing in the surgical treatment of trauma and musculoskeletal disorders. Founded by a group of Swiss surgeons in 1958, the AO has established specialty areas for trauma, spine, craniomaxillofacial (CMF), veterinary (VET), and reconstructive surgery (Recon). The AO's clinical specialties continually redefine the state-of-the-art in their fields, maintaining activities in research, development, clinical investigation, innovation, and education. Today, the AO fosters one of the most extensive global networks of over half a million health-care professionals. Each year we offer over 850 educational events around the world, supported by around 8,000 faculty and attended by over 70,000 participants. To date, the AO has trained more than one million course participants. We have over 20,000 surgeon members working in the fields of trauma, spine, CMF, VET, and Recon. The AO has world-leading institutes in research and innovation, delivering value-added products and services to the AO's clinical specialties, its global network of surgeons and operating room personnel, and to its partners. They create new concepts for improved fracture care, deliver evidence-based decision-making, guarantee rigorous concept and product approval, and ensure the timely and comprehensive dissemination of knowledge and expertise. Innovation at the AO goes from bench to bedside, including basic research, product development, clinical validation, and more information, visit About Trial Interactive Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11-compliant, AI-powered platform delivers an author-to-archive collaboration experience with solutions for clinical document management, site selection, site activation, e-learning, compliance training, quality, and CTMS with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. For more information on Trial Interactive, please contact info@ or +1 212.400.8848, or visit About TransPerfect Life Sciences TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc.), pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 140 cities worldwide, TransPerfect Life Sciences is the ideal partner to simplify your path from lab to launch by driving quality, mitigating compliance risk, and enhancing patient engagement. For more information, please visit our website at Contact: Ryan Simper +1 212.689.5555mediainquiry@
Yahoo
06-05-2025
- Business
- Yahoo
eClinical Solutions Market Size to Lead USD 40,500 Million by 2034, Growth in the Biopharmaceutical and Pharmaceutical Industry
By development phase, the Phase I segment is projected to experience the highest growth rate in the market between 2024 to 2034. By delivery mode, the on-premises segment is observed to grow at a notable rate during the forecast period. By delivery mode, the web and cloud-based segment accounted the highest market share in 2024. By end use, the pharma & biotech organizations segment is predicted to grow with the fastest CAGR in the market from 2025 to 2034. By end use, the Contract Research Organizations (CROs) segment registered the maximum market share in 2024. By product, the electronic clinical outcome assessment (eCOA) segment is predicted grow at the fastest rate in the market between 2025 and 2034. By product, the clinical trial management system (CTMS) segment captured a significant portion of the eClinical solutions market in 2024. Asia Pacific is projected to expand at the fastest CAGR during the forecast period. Received $8 million strategic investment from Mitsui & Co. Ltd. to expand in Asia Pacific. In November 2024, several AI-based Healthcare Innovations were introduced by a leading provider of cloud-based electronic health records (EHR) and practice management solutions, eClinicalWorks. The eClinical solutions market refers to the production, distribution, and use of eClinical solutions, which firstly targets physician practices and allows physicians to view and use as much or as little personal wellness data, with the patient's consent, as they want. eClinical solutions include electronic data capture (EDC), clinical trial management systems (CDMS), randomization and trial supply management (RTSM), and electronic patient-reported outcomes (ePRO). Integration of advanced technologies like machine learning (ML), artificial intelligence (AI), and cloud computing in eClinical solutions improves trial management and data processing modeling continually. eClinical solutions' industry-leading data and analytics platform and biometrics services experts help biopharma researchers at mid-size, large, and emerging life sciences organizations manage trial complexity with fewer resources and less time. The benefits of eClinical solutions include improving trials from acquisition to submission, quickening cycle times, improving productivity, and bringing out tomorrow's breakthroughs. Ottawa, May 06, 2025 (GLOBE NEWSWIRE) -- According to Statifacts, the global eClinical solutions market size surpassed USD 10,730 million in 2024 and is estimated to attain USD 40,500 million by 2034, growing at a CAGR of 14.2% during the forecast period from 2025 to 2034. The eClinical solutions market growth is driven by rising R&D expenditure across the globe, rising adoption of software solutions across the globe, and increasing demand for clinical trials outsourcing. The global eClinical solutions market size is predicted to increase from USD 12,260 million in 2025 and is anticipated to be worth around USD 40,500 million by 2034, expanding at a CAGR of 14.2% from 2025 to 2034. A study published by Statifacts a sister firm of Precedence Research. Story Continues Major Key Trends in the eClinical Solutions Market: Focus on patient-oriented solutions: eClinical solutions improve data accuracy, efficiency, and patient engagement in decentralized clinical trials for more efficient, faster research that brings hope to those who need it most. As compared to traditional trials, patients need to go to a specific clinical site, eClinical solutions, like virtual tools and technologies, making it easier for patients to participate from the comfort of their homes. Rising adoption of telemedicine and remote monitoring: Telemedicine improves self-management, physical activity, and rehabilitation. Telemedicine increases access to continuity and care services for cancer patients, reduces ED times, better medication adherence, and enhances satisfaction scores. Order the Premium Databook Today at the Discounted Rate of $1550! Limitations & Challenges in the eClinical Solutions Market: Data security and privacy issues: Data security and privacy issues in clinical trials can be caused by many behaviors, including significant carelessness, intentional or unintentional non-compliance, misconduct, and fraud. They can compromise the validity of the study results. Lack of awareness of eClinical solutions: Lack of awareness of clinical trials can be a reason for lower patient participation. Lack of awareness can reduce recruitment for cancer clinical trials. Development of eClinical Solutions Platforms: Market's Largest Potential eClinical solutions platforms are a type of randomized clinical trial that enables the simultaneous comparison of many intervention groups against a single control group that acts as a common based on a prespecified interim analysis plan. eClinical solutions platform transforms healthcare management with HMS/HER software, pharmacy management system, and LIMS. eClinical solutions platform built for IVF/fertility, dental, mental health, and medical health clinics. In September 2023, the eClinical Platform App in China, ensuring full compliance and accessibility, was launched by a leading global provider of innovative solutions for patient engagement and data collection in clinical trials, Datacubed Health. eClinical Solutions Market Scope Report Attribute Key Statistics Market Size in 2025 USD 12,260 Million Market Size by 2034 USD 40,500 Million Growth Rate from 2025 to 2034 CAGR of 14.2% Largest Market North America Fastest Growing Market Asia Pacific Base Year 2024 Forecast Period 2025 to 2034 Segments Covered By Product, By Delivery Mode, By Development Phase, By End-use, and By Region Regions Covered North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa Regional Analysis: North America held the Dominant position: Technological Advancement to Support Growth North America dominated the global eClinical solutions market in 2024. Changing lifestyle, rising target population, rising adoption of information on patient health through eClinical solutions, and rising digitalization are driving the growth of the market in North America. Major Factors for the Market's Expansion in North America In June 2024, a new digital bank for the US healthcare industry, powered by Finastra, was launched by Bank Midwest. In April 2025, the launch of the CORE 500 Digital Stethoscope and Eko+ membership in Canada was announced by Eko Health. Strategic Investments & Acquisitions in North America Ascertain: In May 2025, Ascertain, a healthcare startup led by former Amazon executive Dr. Mark Michalski, secured $10 million in Series A funding . The investment was led by Deerfield Management and aims to enhance healthcare administration using AI agents. Science 37: In March 2024, Science 37, a company specializing in decentralized clinical trials, was acquired by eMed, LLC. This acquisition enhances eMed's capabilities in telehealth and diagnostics, expanding its reach in the e-clinical solutions market. Syneos Health: In March 2023, Syneos Health signed a multi-year deal to collaborate with Microsoft Research in developing a platform to leverage machine learning for the optimization of clinical trials. This partnership aims to enhance Syneos Health's capabilities in providing e-clinical solutions. What Expect from Asian Countries till 2034? Asia Pacific is projected to host the fastest-growing market in the coming years. Rising R&D spending across the globe, rising software solutions adoption in clinical trials, and increasing government funding in clinical trials are driving the growth of the eClinical solutions market in the Asia Pacific region. Top Asian Countries for eClinical Solutions India: In February 2025, the India Digital Health Activator, a new initiative to accelerate digital health adoption, interoperability, and innovation through public-private collaboration, was launched by the World Economic Forum (WEF). Japan: In February 2025, to revolutionize digital transformation in Japan's life sciences sector, the global leader in enterprise validation lifecycle management systems (VLMS), ValGenesis Inc., and Hitachi Industry & Control Solutions, Ltd., collaborated. eClinical Solutions Market Segmentation Insights Product Insights The clinical trial management system (CTMS) segment held a dominant presence in the eClinical solutions market in 2024. The benefits of CTMS include access to up-to-date and accurate study information. A CTMS automates and centralizes various trial management functions from planning to study closure. CTMS helps teams ensure regulatory compliance, reduce errors, and enhance collaboration by providing a single source of truth for all trial data. The electronic clinical outcome assessment (eCOA) segment is expected to grow at the fastest rate in the market during the forecast period of 2025 to 2034. The eCOA application is designed to accurately capture PRO data. It offers a range of customizable assessments and diaries tailored to meet the specific requirements of each clinical trial. End Use Insights The Contract Research Organizations (CROs) segment accounted for a considerable share of the eClinical solutions market in 2024. The CRO provides clinical, scientific, and business continuity for clinical trial sponsors. In advancing clinical research, CRO play an important role. They provide a controlled and structured environment to test new drugs, treatments, and other medical devices before being approved for widespread use. The pharma & biotech organizations segment is projected to experience the highest growth rate in the market between 2024 to 2034. Pharma & biotech organizations have a major role in drug discovery and development for the understanding of many diseases and their new treatment strategies and therapeutic interventions. Delivery Mode Insights The web and cloud-based segment led the eClinical solutions market. The benefits of web and cloud-based clinical solutions include reducing the risk of data loss, reducing network equipment & staff costs, increasing patient data accessibility, automating data scalability & processing, and accelerating clinical analyses and care processes. On-premises segment is set to experience the fastest rate of market growth from 2025 to 2034. On-premises storage can ensure the security and accessibility of sensitive patient data. It offers full control over data, customization options, and improved security. Development Phase Insights The Phase III segment registered its dominance over the eClinical solutions market in 2024. Phase III trial collects comprehensive safety data, enabling researchers and regulatory authorities to make informed decisions about the benefits of the drug versus its potential risks. The Phase I segment is anticipated to grow with the highest CAGR in the market during the studied years. Phase I studies of a new drug are generally the first that involve people. Phase I studies are used to find the highest dose of the new treatment that can be given safely without causing severe side effects. Browse More Research Reports: The U.S. eClinical solutions market size surpassed USD 3,840 million in 2024 and is predicted to reach around USD 13,010 million by 2034, registering a CAGR of 12.98% from 2025 to 2034. The U.S. preclinical CRO market size accounted for USD 2,120 million in 2024 and is expected to exceed around USD 4,660 million by 2034, growing at a CAGR of 8.2% from 2025 to 2034. The global medical device clinical trials market size was valued at USD 17.19 billion in 2024 and is expected to hit around USD 31.34 billion by 2034 with a CAGR of 6.19% from 2025 to 2034. The U.S. clinical workflow solutions market size is calculated at USD 3,600 million in 2024 and is predicted to reach around USD 16,160 million by 2034, expanding at a CAGR of 16.2% from 2025 to 2034. Order the Premium Databook Today at the Discounted Rate of $1550! eClinical Solutions Market Top Companies: Fountayn, formerly known as Datatrak International, Inc. Oracle Calyx, formerly part of Parexel International Corporation Medidata (Dassault Systemes) CRF Health (Signant Health) Clario (ERT and Bioclinica) eClinicalWorks Merative (IBM Watson Health) Anju Software eClinical Solutions MaxisIT IQVIA Castor Veeva Systems Recent Breakthroughs in the Global eClinical Solutions Market: In March 2025, the tech-driven Aayu Chemist app and Medcords platform from Medcords Healthcare Solutions were launched by Entero Healthcare. In July 2024, the North American launch of the Integrated Solution for Digital Transformation in Pathology was announced by AGFA HealthCare and Corista. Segments Covered in the Report By Product Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS) Clinical Trial Management Systems (CTMS) Clinical Analytics Platforms Randomization and Trial Supply Management (RTSM) Clinical Data Integration Platforms Electronic Clinical Outcome Assessment (eCOA) Safety Solutions Electronic Trial Master File (eTMF) Electronic Consent (eConsent) By Delivery Mode Cloud and Web Based On-Premise By Development Phase Phase I Phase II Phase III Phase IV By End-use Hospitals/Healthcare providers Contract Research Organizations (CROs) Academic Institutes Pharma & Biotech Organizations Medical Device Manufacturers By Region North America Europe Asia Pacific Latin America Middle East & Africa You can place an order or ask any questions, please feel free to contact us at sales@ Statifacts offers subscription services for data and analytics insights. This page provides options to explore and purchase a subscription tailored to your needs, granting access to valuable statistical resources and tools. Access here - Contact US Ballindamm 22, 20095 Hamburg, Germany Web: Europe: +44 7383 092 044 About US Statifacts is a leading provider of comprehensive market research and analytics services, offering over 1,000,000 market and custoer data sets across various industries. Their platform enables businesses to make informed strategic decisions by providing full access to statistics, downloadable in formats such as XLS, PDF, and PNG. Our Trusted Data Partners: Precedence Research | Towards Healthcare | Towards Packaging | Towards Automotive | Towards Food and Beverages | Towards Chemical and Materials | Towards Dental | Towards EV Solutions | Nova One Advisor
Associated Press
27-03-2025
- Business
- Associated Press
Crucial Data Solutions Launches Industry-First Subscription Model to Modernize Clinical Trial Contracting and Pricing
New model empowers CROs to grow revenue, reduces costs for sponsors, and accelerates time to market 'Technology should help sponsors and CROs do more with less, not pay more to work harder.' — Jim Bob Ward, CEO RENO, NV, UNITED STATES, March 27, 2025 / / -- Crucial Data Solutions, Inc. (CDS), provider of TrialKit, the only mobile-first, AI-powered eClinical platform, today announced a bold transformation of its pricing and contracting model. With a new subscription-based model designed to lower costs, simplify workflows, and speed up study timelines, CDS is tackling one of the most entrenched inefficiencies in the life sciences industry: outdated business models and fragmented technologies. 'Technology should help sponsors and CROs do more with less, not pay more to work harder,' said Jim Bob Ward, CEO of Crucial Data Solutions. 'We believe modernization extends beyond software. It must also reshape how studies are contracted, priced, and delivered.' This announcement comes at a pivotal moment, following FDA guidance calling for modernization through decentralized trial strategies and digital health technologies (DHTs). While regulatory initiatives have ignited demand for hybrid trials, many organizations remain burdened by high-cost, piecemeal tech stacks patched together by APIs, custom integrations, and per-study contracts. CDS is responding with a unified platform and transparent pricing model that gives customers full access to all eClinical products without the added complexity. After 15 years of investment in a single-platform architecture that supports both web and native mobile environments (iOS and Android), CDS is making its full TrialKit platform—including EDC, eCOA/ePRO, eConsent, RTSM, eTMF, and AI-powered analytics—available through a monthly subscription. Pricing starts at $1,350/month for one study, scaling up to $90,000/month for unlimited studies. 'There's no need for lengthy RFIs, RFPs, or repeated contract negotiations,' said Ward. 'We build the first study with our customers, guide them through the second, and then hand over the keys. This model enables our partners to scale their operations while dramatically reducing per-study costs.' TrialKit remains the only platform that enables full customer control over study configuration via a drag-and-drop designer across both desktop and mobile, backed by integrated AI analytics and the ability to private-label and localize the experience. Used by more than 40,000 users to build over 10,000 studies, TrialKit's proven foundation makes this shift to subscription-based pricing a natural extension, and one CDS can offer while remaining profitable and debt-free. Crucial Data Solutions is publicly publishing its subscription pricing to bring full transparency to the industry. To explore pricing tiers and learn more about the model, visit About Crucial Data Solutions Founded in 2010, Crucial Data Solutions (CDS) is the provider of TrialKit, the most innovative eClinical platform on the market. Trusted by sponsors, CROs, and research institutions worldwide, TrialKit supports the end-to-end management of clinical trials and non-interventional studies. CDS is committed to making advanced data collection and management solutions accessible to all, combining affordability, scalability, and cutting-edge technology to meet the evolving needs of the life sciences industry. Carley Nolan, Director of Marketing Legal Disclaimer:
Yahoo
14-03-2025
- Health
- Yahoo
Sooma gains FDA approval to commence study of tDCS device
Sooma Medical has received the approval of an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), allowing the company to initiate a pivotal study of its transcranial direct current stimulation (tDCS) medical device, Sooma 2GEN, as a home-based treatment for major depressive disorder (MDD). The study will evaluate the efficacy and safety of the device, which is designed as a wearable cap that enables low-level electrical current delivery to the brain leveraging tDCS therapy. This non-invasive technique aims to ease symptoms of depression eliminating the need for pharmaceuticals. In collaboration with Lindus Health, Sooma Medical will conduct the trial involving 200 subjects across the US. Lindus Health will leverage its virtual site offerings for subject recruitment and trial management, employing Citrus, its eClinical platform, for study-related activities. Sooma's portable neuromodulation device provides a flexible and accessible treatment option for individuals with MDD. The device has already received breakthrough device designation from the US regulator. It claims to be a brain stimulation treatment that patients can utilise safely at home. Sooma 2GEN is already cleared for treating the condition in 35 countries The US trial's positive outcomes are expected to further substantiate the device's safety and efficacy, backing the company's efforts to gain clinical validation for the tDCS therapy in the US market. Sooma Medical CEO and co-founder Tuomas Neuvonen stated: 'Until now, early-stage treatment options have been limited for patients who don't respond to medication or lack access to therapy. Those who have tried several antidepressants without success are considered treatment-resistant, which affects their prognosis and hope for improvement. 'We're excited to partner with Lindus Health to generate the US data that will demonstrate Sooma 2GEN's capabilities in improving the quality of life in depression patients.' "Sooma gains FDA approval to commence study of tDCS device" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
