Beyond Headlines Into Insight
CluePoints is a cloud-based software platform specializing in Risk-Based Quality Management (RBQM) and data quality oversight in clinical trials. The platform is designed to streamline processes, improve data integrity, and ensure risk compliance, making clinical trials safer and more efficient. The investment by EQT, a firm with a strong track record in healthcare and technology,
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This guideline, which ensures regulatory compliance with the requirements of ICH GCP E6, came into effect on 9 September 2023. It introduced a new consolidated framework of standards for computerised systems and electronic data in clinical trials. It is a unique guideline in its thoroughness and extent on the matter. OSP had a conversation with Vesta
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IQVIA recognized the intricate challenges associated with participant payments in clinical trials, which often involve cumbersome processes and multiple vendors, leading to delays and dissatisfaction among participants. Jim provides insights into the motivations and objectives behind launching this comprehensive solution. Can you explain the core motivations behind launching IQVIA’s participant payments service? IQVIA recognized the
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In an interview with Biopharma Reporter, Mainz Biomed CEO Guido Baechler explains how his company’s stool test for colorectal cancer compares with well known, multicancer blood tests like Galleri. Early detection blood tests such as Grail’s Galleri typically involve isolating DNA from the blood and deploying machine-learning algorithms to scan the DNA for early signs
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The panel featured Ariel Berger, executive director of integrated solutions and real-world evidence at Aventura; John Van Hoy, executive director of AI and advanced analytics at PPD; and Gino Pirro, vice president of product and technology at PPD. The conversation highlighted how AI and real-world data are transforming the landscape of clinical trials. Disease models
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Last year, Astellas Pharma established a behavioral science consortium to perform research aimed at better understanding what matters to patients and their carers, findings that will be channeled into drug development. Health organizations are developing a keen interest in behavioral science too. The World Health Organization (WHO) recently appealed for experts to join its global
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This first-of-its-kind phase 2 grant will expedite the commercialization of cannabinoid ingredient production via precision fermentation. The funding aims to develop cost-effective active pharmaceutical ingredients for treating conditions such as appetite suppression, obesity, inflammation, and diabetes. Cellibre, established in 2019 by a team of biomanufacturing innovators, is dedicated to creating a sustainable manufacturing company that
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In a groundbreaking development, Systech, a subsidiary of Markem-Imaje and Dover, has introduced a turnkey manual aggregation and rework solution tailored for pharmaceutical manufacturers, CMOs, CDMOs, re-packagers, and wholesalers.
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Spectrum supports study teams by providing real-time predictions and control over trial timelines and costs, ensuring successful trials in today’s complex landscape. Clinical trials today are more intricate than ever. Late-phase studies now collect over 3.5 million data points, triple the amount from a decade ago, and must juggle an average of 26 endpoints, including
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This key study explores the influence of CYP2C9 genetic polymorphisms on the pharmacokinetics (PK) of delta-9-tetrahydrocannabinol (THC) and its active metabolites in Alzheimer’s disease (AD) patients. Titled ‘A study on CYP2C9 polymorphism, in Puerto Rican Alzheimer’s patients and its role in the Pharmacokinetics of ∆-9-tetrahydrocannabinol,’ it is accessible at the European Society of Medicine website.
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