CluePoints Supports Launch of RBQMLive 2024 as Premier Event Sponsor
KING OF PRUSSIA, Pa., Sept. 4, 2024 /PRNewswire/ — CluePoints, the premier sponsor of RBQMLive and provider of Risk-Based Quality Management (RBQM) and Data Quality Oversight Software, has revealed the full agenda and speaker line up for the award-winning RBQMLive event. RBQMLive is the industry-leading event for anyone working with, or interested in risk-based quality management approaches.

RBQMLive, taking place on September 24-25, 2024, is a free, virtual event offering attendees the opportunity to immerse themselves in cutting-edge discussions, workshops and networking opportunities. From transformative shifts in RBQM to global regulatory updates and the emergence of new technologies, this virtual event equips attendees with all they need to continue their RBQM journey and drive further efficiency gains across all clinical trials.
Last year’s event was attended by more than 1,000 delegates from over 375 organizations. RBQMLive 2024 is set to be even bigger and better with new opportunities to collaborate and drive positive change within the clinical trial landscape.
On day one, the keynote address, Unlocking the Path to RBQM Maturity, will again be delivered by Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development. Ken will explore evidence-based insights showcasing the increase in RBQM adoption, uncover factors driving and hindering RBQM usage and share actionable insights from the recent empirical research findings.
Other day one highlights include:
Taking RBQM into New Dimensions – Understanding the Risk-Based Data Management (RBDM) Revolution with Miguel Valenzuela, Associate Director of Clinical Operations, RBQM at Alnylam, Paul MacDonald, Senior Director Vault CDMS Strategy at Veeva and Patrick Nadonly, Global Head, Clinical Data Management, Sanofi.The Emergence of AI & ML in RBQM: What’s here now and what is to come? with Marcin Makowski, Head of Centralized Monitoring & Data Analytics, GSK and Bob Zambon, Vice President, Technology Strategy & Strategic Partnerships, Syneos Health.Key themes on day two include the future of RBQM, enhanced data quality and optimizing study oversight. Highlights include:
RBQM Industry Guidance Evolution – Adapting to Modernization with Olivia Feiro, Director, Risk Management & Analytics at CSL Behring, Lotte Smets, Director of Data Management at Julius Clinical and Daniel DiJohnson, Risk-Based Quality Management SME, Senior Manager, Parexel.Enhancing Data Quality through Advanced Audit Trail Review with Paola Peshkepija, Senior Associate Central Monitor, Pfizer and Jennifer Nielsen, Senior Specialist, Clinical Data Management, Lundbeck.Integrated Data Review: Optimizing Study Oversight with Brian Barnes, Director of Risk Management Strategy – Process Excellence & Oversight at BioNTech, Jess Thompson, Founder of Clinical Research Project Management Association and Alaine Heffernan, Director Centralized Monitoring, Allucent.Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, commented, “Risk-based quality management is evolving, and industry adoption is increasing fast. RBQMLive is a unique event which brings together global specialists, industry experts and anyone who is interested in finding out more about this transformative approach to managing clinical trials. This year’s exciting program looks set to make RBQMLive 2024 bigger and better than ever and we urge everyone to register for their free place.”
RBQMLive 2024 takes place virtually from September 24-25. Visit rbqmlive.com/rbqm-live-2024-agenda for more information and to register.
About CluePoints
CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. We are leveraging the potential of Artificial Intelligence using Advanced Statistics and Machine Learning to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.
 

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PHILADELPHIA, Sept. 4, 2024 /PRNewswire/ — Signant Health, the leader in evidence generation for modern clinical trials, announced today it has joined IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, in its One Home for Sites™ initiative. 

IQVIA One Home for Sites is an industry-wide collaboration designed to simplify site conduct when clinical research staff leverage multiple eClinical technologies from multiple solution providers on a trial. Through single sign-on to a common platform, sites enjoy simplified access to trial technologies from IQVIA and other technology partners that have taken the steps to participate in One Home.  
One such technology solution that will appear on the One Home for Sites platform is Signant SmartSignals® Unified Platform, itself a fully integrated solution consisting of eCOA, EDC, RTSM, eConsent, and telemedicine.
“We are very pleased to have our Unified Platform now available within One Home for Sites,” said Sanjiv Waghmare, Signant’s chief product officer. “IQVIA’s industry-wide, collaborative approach aligns well with our overall product strategy to homogenize access to all our products through a single environment we call Signant SmartSignals® ID Portal. We applaud IQVIA’s efforts to extend this philosophy by consolidating multiple solution providers into one ecosystem for easy access by sites.”   
“Signant Health quickly recognized the power of One Home for Sites to capture synergies across the industry and deliver a better experience to sites,” said Melissa Easy, VP of Commercialization for IQVIA Technologies Digital Products and Services. “We welcome Signant to One Home and look forward to their continued contribution to building the next-generation clinical trial ecosystem that benefits all stakeholders – especially the patients we serve.”
About Signant Health
Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 25 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, EDC, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at www.signanthealth.com.
About IQVIA
IQVIA (NYSE: IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.
Contact:Heather [email protected]+1 610.400.4141

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Phesi’s Trial Accelerator™ Platform empowers trial sponsors to make informed decisions swiftly, expediting drug development timelines while upholding the highest standards of data integrity and patient-centricity
SAN ANTONIO, Sept. 4, 2024 /PRNewswire/ — Frost & Sullivan has recognized Phesi with the 2024 Global Enabling Technology Leadership Award after analyzing the AI-enabled clinical trial design industry. Phesi delivers clinical development analytical products and services to biopharmaceutical companies worldwide. Employing cutting-edge technologies, the company offers the world’s largest contextualized clinical development database through its Trial Accelerator™ platform, alongside sophisticated patient-centric analytics tools. Phesi aggregates global data and develops integrated algorithms to analyze patient data, trial protocols and execution strategies to optimize trial designs for improved outcomes. Its AI-driven solutions for clinical trial simulation, patient profiling, program and protocol design, trial execution, and digital twins, support life sciences companies in accelerating drug development and commercialization.

Frost & Sullivan presents this annual award to a company that has developed pioneering technology that not only enhances current products but enables the development of new products and applications.
Aarti Siddhesh Chitale, healthcare senior industry analyst at Frost & Sullivan, observed, “We are pleased to recognize Phesi as the deserving recipient of the Global Enabling Technology Leadership Award. Phesi has revolutionized clinical development with its industry-leading Trial Accelerator Platform. By empowering sponsors and equipping them with advanced analytics and contextualized data, Phesi is enabling clients in pharmaceutical and biotech firms to improve efficiency in trial design and execution.”
“For two decades, we’ve been supporting the clinical development industry to adopt a data-driven approach that accelerates innovation,” commented Dr Gen Li, CEO and Founder, Phesi. “This award from Frost & Sullivan is reflective of our ongoing efforts to help the industry conduct smarter trials to achieve faster cures for patients in need. Trial Accelerator drives unrivaled precision and insight and delivers a comprehensive patient view from the outset, enabling sponsors to optimize trial design, reduce patient burden, and select investigator sites and countries with precision across all indications and patient subpopulations. Using patient-centric data to inform and optimize trial protocol design will lay the groundwork to successfully deploy external control arms and digital twins, minimizing the burden on patients and investigators even further. Our future-proof platform will eventually lead to replacing clinical trial control arms with digital twins.”
The SaaS AI-driven Trial Accelerator consolidates patient data from 120 million individuals globally in more than 4,000 indications. Clients are equipped with insight across all indications at a granular level, including subpopulations driven by medical need and medical profile. Phesi’s platform and services also equip sponsors with the tools to utilize study and control arm data, and to create digital twins. The Health Check and Trial Rescue service identifies and resolves issues to ensure seamless progression of clinical trials. Using Trial Accelerator, Phesi evaluates trial synopses, protocols or amendments from patient, country, investigator sites, and KOL perspectives; offering insights on crucial design elements to address persistent clinical trial challenges. Given that Phase III trial protocols undergo an average of 3.3 significant amendments, incurring costs of up to $1.5 million per trial, Phesi’s innovative approach offers a cost-effective solution for optimizing trial efficiency and success. Its unique industry position and ability to provide digital twins and external control arms distinguish it from competitors, as do its precise and comprehensive datasets.
“Phesi guides clients towards innovative trials and faster cures, solidifying its status as a trailblazer in AI-enabled patient centric data software services. Trial Accelerator has consistently been proven to minimize amendments and shorten cycle times, helping companies deliver lifesaving medicines to patients. We believe Phesi is poised to shape the future of healthcare through its data-driven innovation and patient-centric outlook,” added Norazah Bachok, best practices research analyst at Frost & Sullivan.
Each year, Frost & Sullivan presents this award to a company that has developed a pioneering technology that not only enhances current products, but also enables the development of new products and applications. The award recognizes the high market acceptance potential of the recipient’s technology.
Frost & Sullivan Best Practices awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in 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 in the industry.
About Frost & SullivanFor six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, megatrends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion. Contact us: Start the discussion.
Contact:Camila TinajeroE: [email protected]
About PhesiPhesi is a global provider of AI-powered patient-centric data analytics, and clinical development products and solutions to the biopharmaceutical industry. The company’s integrated offerings cover the entire clinical development process — from development planning and indication assessment to protocol evaluation, site selection, and trial implementation management. Phesi has the world’s largest and most dynamic real-time clinical development database; delivering patient-centric data science that enables biopharmaceutical companies to predict and optimize clinical development outcomes in any indication. Its database integrates data from 90,000 sources; consisting of records from 120+ million patients, 485,000+ curated clinical trials, 604,000 completed research projects, 4.2 million physicians, 600,000 investigator sites in 195 countries, and 4,000+ disease indications. Phesi delivers data, insights and answers, enabling smarter trials and faster cures. Visit www.phesi.com for more information.
ContactSpark [email protected]+44 207 436 0420
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