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Curavit to lead US trial of Nestmedic's prenatal monitoring solution
Curavit to lead US trial of Nestmedic's prenatal monitoring solution

Yahoo

time7 days ago

  • Business
  • Yahoo

Curavit to lead US trial of Nestmedic's prenatal monitoring solution

Polish medtech company Nestmedic has chosen Curavit Clinical Research to spearhead the US clinical study of the remote prenatal monitoring solution, PregnaOne. The non-significant risk (NSR) trial is set to enrol 50 expectant mothers over 11 months across the country to assess the effectiveness and safety of the solution when used at home. This foundational study aims to gather evidence to facilitate upcoming regulatory clearance in the US. Curavit will oversee all trial aspects, including institutional review board (IRB) submissions, site choosing, data management, contract and monitoring, selection of clinical data capture software, data analytics, as well as the clinical study report (CSR) preparation. Nestmedic CEO Jacek Gnich said: 'We are building technology with empathy at its core. Curavit's innovation-forward approach, medical device expertise, and deep clinical trial experience make them the ideal partner to run this pivotal study in the US.' At least three clinical sites will be chosen, focusing on participant diversity in terms of geography and demographics. Curavit noted that a centralised healthcare provider (HCP) data review and adjudication process implementation will take place to ensure the quality and consistency of the data. Curavit Clinical Research CEO and co-founder Joel Morse said: 'We are honoured to support Nestmedic in bringing PregnaOne to market. 'Their mission to improve prenatal care through remote monitoring perfectly aligns with Curavit's vision to partner with innovative medical device companies that are working to expand access to healthcare.' In 2023, Curavit Clinical Research introduced a Health Economics and Outcomes Research (HEOR) service for clinical studies. In the same year, MedRhythms chose Curavit as its virtual contract research organisation (VCRO) for a trial of its MR-001 neurorehabilitation system. "Curavit to lead US trial of Nestmedic's prenatal monitoring solution" 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. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Analysis Group Co-Authors Examine the Advancements in and Application of Health Economics and Outcomes Research to the Evaluation of Cell and Gene Therapies for Rare Diseases
Analysis Group Co-Authors Examine the Advancements in and Application of Health Economics and Outcomes Research to the Evaluation of Cell and Gene Therapies for Rare Diseases

Yahoo

time22-07-2025

  • Health
  • Yahoo

Analysis Group Co-Authors Examine the Advancements in and Application of Health Economics and Outcomes Research to the Evaluation of Cell and Gene Therapies for Rare Diseases

BOSTON, July 22, 2025 /PRNewswire/ -- In a new article published in Value in Health, researchers from Analysis Group, a global leader in health economics and outcomes research (HEOR), collaborated with Novartis to examine how HEOR is transforming the evaluation and access pathways for cell and gene therapies (CGTs) for rare diseases. As CGTs move from experimental to increasingly approved treatments for rare diseases, health systems face urgent questions about how to evaluate, reimburse, and scale their access equitably. In their article, the authors spotlight five key HEOR innovation areas that are enhancing the generation of real-world evidence (RWE), supporting novel endpoints, and shaping future models of affordability and access. Because of small patient populations, heterogeneous disease presentations, a lack of effective alternative treatments, and hence, ethical concerns, gold standard randomized double-blind controlled clinical trials are often not suitable for establishing efficacy and safety for CGT treatments. Consequently, traditional economic models are not able to capture the holistic value of CGTs, given that the true benefits associated with such treatments are subject to a much longer time outside of the trial periods. For example, for patients with rare hereditary genetic disorders, timely access to CGTs can yield real differences in meaningful gains in life years. To address these challenges, researchers are increasingly relying on innovations in HEOR to inform proper clinical and economic evaluation of CGTs. An Analysis Group team led by Managing Principal Min Yang, Manager Su Zhang, and affiliate Lou Garrison collaborated with researchers from Novartis, led by Dr. Walter Toro, to examine the advancements in the evaluation of CGTs made possible by HEOR innovations, including the design and collection of long-term real-world data (RWD) for CGT efficacy extrapolation, justification for use of novel endpoints, integration of patient voices and preferences, and application of sophisticated statistical methodology, sometimes augmented with artificial intelligence (AI) or natural language processors. These advances are reflected in regulators' and health technology assessment (HTA) agencies' growing openness to the acceptance of RWE and patient-centered endpoints in their evaluations, marking a shift from traditional standards that may not suit CGTs. The authors note that emerging value assessment frameworks and novel reimbursement models offer solutions and adaptability to decision makers with enhanced ability to manage health equity and affordability.

ISPOR UAE Chapter and AbbVie announce intent to collaborate on healthcare advancement
ISPOR UAE Chapter and AbbVie announce intent to collaborate on healthcare advancement

Khaleej Times

time21-04-2025

  • Health
  • Khaleej Times

ISPOR UAE Chapter and AbbVie announce intent to collaborate on healthcare advancement

The ISPOR UAE Chapter, the local chapter of the leading international scientific and educational organization for health economics and outcomes research (HEOR), and AbbVie, a global biopharmaceutical company, have announced their intent to explore collaborative opportunities aimed at enhancing healthcare outcomes in the UAE. The Letter of Intent (LOI) was signed during the Abu Dhabi Global Health Week in the presence of senior board members from the ISPOR UAE Chapter and senior leadership from AbbVie Gulf. The LOI signifies a mutual commitment to work together in key areas including Health Technology Assessment (HTA) and policy shaping, as well as research and evidence generation. This collaboration aims to leverage the ISPOR UAE Chapter's extensive network and knowledge in HEOR and AbbVie's scientific expertise to contribute to a more robust and evidence-based healthcare system in the UAE. Prof. Nadia Al Mazrouei, ISPOR UAE Chapter President, emphasised that 'The ISPOR UAE Chapter is dedicated to fostering excellence in health economics and outcomes research to inform healthcare decisions in the UAE. This Letter of Intent with AbbVie, formalized during the prestigious Abu Dhabi Global Health Week, marks an important step in bridging our network of researchers, policymakers, and healthcare professionals with industry expertise. We are enthusiastic about the potential of this collaboration to generate impactful research and contribute to the development of evidence-based policies that benefit patients across the UAE.' Elhussein Abdellatif, General Manager Gulf Levant AbbVie, stated, 'We are proud to reaffirm our commitment to elevating the standards of care and enhancing patients' lives. We understand the vital importance of Health Technology Assessment (HTA) and health policy in supporting access to essential therapies. Our collaboration with the ISPOR UAE Chapter provides us with an opportunity to share our expertise and collectively advance toward a more sustainable and patient-focused healthcare ecosystem in the UAE.'

ISPOR UAE Chapter and AbbVie announce intent to collaborate on healthcare advancement at Abu Dhabi Global Health Week
ISPOR UAE Chapter and AbbVie announce intent to collaborate on healthcare advancement at Abu Dhabi Global Health Week

Zawya

time18-04-2025

  • Health
  • Zawya

ISPOR UAE Chapter and AbbVie announce intent to collaborate on healthcare advancement at Abu Dhabi Global Health Week

Abu Dhabi, UAE: The ISPOR UAE Chapter, the local chapter of the leading international scientific and educational organization for health economics and outcomes research (HEOR), and AbbVie, a global biopharmaceutical company, today announced their intent to explore collaborative opportunities aimed at enhancing healthcare outcomes in the UAE. The Letter of Intent (LOI) was signed during the Abu Dhabi Global Health Week in the presence of senior board members from the ISPOR UAE Chapter and senior leadership from AbbVie Gulf. The LOI signifies a mutual commitment to work together in key areas including Health Technology Assessment (HTA) and policy shaping, as well as research and evidence generation. This collaboration aims to leverage the ISPOR UAE Chapter's extensive network and knowledge in HEOR and AbbVie's scientific expertise to contribute to a more robust and evidence-based healthcare system in the UAE. Prof. Nadia Al Mazrouei, ISPOR UAE Chapter President, emphasized that 'The ISPOR UAE Chapter is dedicated to fostering excellence in health economics and outcomes research to inform healthcare decisions in the UAE. This Letter of Intent with AbbVie, formalized during the prestigious Abu Dhabi Global Health Week, marks an important step in bridging our network of researchers, policymakers, and healthcare professionals with industry expertise. We are enthusiastic about the potential of this collaboration to generate impactful research and contribute to the development of evidence-based policies that benefit patients across the UAE.' Elhussein Abdellatif, General Manager Gulf Levant AbbVie, stated, 'We are proud to reaffirm our commitment to elevating the standards of care and enhancing patients' lives. We understand the vital importance of Health Technology Assessment (HTA) and health policy in supporting access to essential therapies. Our collaboration with the ISPOR UAE Chapter provides us with an opportunity to share our expertise and collectively advance toward a more sustainable and patient-focused healthcare ecosystem in the UAE.' About ISPOR UAE Chapter: The ISPOR UAE Chapter is the local chapter of ISPOR – the International Society for Pharmacoeconomics and Outcomes Research. It serves as a platform for researchers, policymakers, healthcare professionals, and industry stakeholders in the UAE to advance the science and application of HEOR to improve healthcare decisions. About AbbVie: AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio.

Turacoz Group Leads the Future of Evidence Synthesis With AI-Powered Living Systematic Reviews at World Evidence, Pricing and Access (EPA) Congress, Europe 2025
Turacoz Group Leads the Future of Evidence Synthesis With AI-Powered Living Systematic Reviews at World Evidence, Pricing and Access (EPA) Congress, Europe 2025

Associated Press

time12-03-2025

  • Business
  • Associated Press

Turacoz Group Leads the Future of Evidence Synthesis With AI-Powered Living Systematic Reviews at World Evidence, Pricing and Access (EPA) Congress, Europe 2025

UTRECHT, Netherlands, March 12, 2025 /PRNewswire/ -- Turacoz Group, a leader in real-world evidence (RWE) and health economics and outcomes research (HEOR), showcased insights on AI-powered living systematic reviews (LSRs) at the World EPA 2025 Conference. The event brought together global healthcare leaders to discuss evolving market access strategies and AI-driven innovations in evidence synthesis. Dr. Namrata Singh, Founder and CEO of Turacoz Group, delivered a compelling oral presentation titled 'Revolutionizing Evidence Synthesis – The Role of Artificial Intelligence in Living Systematic Reviews (LSRs).' Turacoz also presented a scientific poster on AI-driven methodologies, further demonstrating its commitment to advancing evidence synthesis. The presentation explored how machine learning and automation transform evidence synthesis, enable real-time literature updates, and improve healthcare decision-making. Additionally, Turacoz shared findings from an HCP survey, assessing knowledge, attitudes, and practices related to living publications. As the demand for real-time, high-quality healthcare data continues to grow, AI-driven systematic literature reviews, bias detection algorithms, and adaptive meta-analyses are revolutionizing post-market surveillance, health technology assessments (HTAs), and comparative effectiveness research (CER). These innovations enhance the efficiency and accuracy of healthcare insights, supporting informed decision-making across the industry. Dr. Namrata Singh emphasized the critical role of AI in modern evidence-based medicine, stating, 'In an era of rapid advancements and vast data sources, it is essential to develop innovative methodologies for gathering, synthesizing, and disseminating high-quality evidence. AI-powered solutions enhance the accuracy, timeliness, and accessibility of medical insights, empowering healthcare professionals to make well-informed, data-driven decisions that improve patient care and drive scientific progress.' Turacoz Group leveraged its expertise in AI-driven RWE and HEOR services to provide strategic support in real-world data analytics, systematic reviews, medical writing, and regulatory submissions. By generating high-quality evidence and conducting comprehensive health economics research, Turacoz helps organizations navigate complex healthcare landscapes, demonstrating the value and impact of medical interventions. Committed to innovation, Turacoz empowers pharmaceutical, biotechnology, and healthcare stakeholders to make data-driven decisions that enhance patient outcomes, improve healthcare efficiencies, and optimize market access strategies. About Turacoz Group Turacoz Group partners with biopharma companies, medtech firms, healthcare professionals, and research institutes, offering expert guidance in product and service development. Specializing in clear, cohesive, complete, concise, and concrete scientific communication, we ensure complex data are effectively conveyed across print and digital formats. With deep expertise in RWE and HEOR, we provide AI-driven insights, systematic reviews, and real-world data analysis, enabling clients to make evidence-based decisions that drive innovation, improve patient care, and enhance market access.

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