Search

Reading Time: 3 minutesBreast Cancer Awareness Month has occurred every October for over four decades. The month seeks to promote awareness and education about early detection, treatments, symptoms, and risk factors for breast cancer. Increased overall awareness has helped to improve mortality rates and prognoses, but there’s still work to be done to fight against this disease. Due […]

Article

Reading Time: 5 minutesWhat Are Medical Devices? As defined in Section 201 of the Federal Food, Drug, and Cosmetic Act, a medical device is: “An instrument...intended for use in the “diagnosis...cure, mitigation, treatment or prevention of disease...and primary purpose not through chemical action within or on the body...” This differs from in vitro diagnostics (IVD) products, which are defined […]

Article

Reading Time: 4 minutesThis blog was written by Sheri Lillis, RTSM Solution Services Principal at Medidata. Clinical trials continue to rapidly grow in complexity, largely driven by increasingly sophisticated protocols, both from scientific and operational perspectives. As sponsors adopt more diverse designs, their randomization and trial supply management (RTSM) systems (sometimes referred to as interactive response technology [IRT]) […]

Article

Reading Time: 2 minutes Glioblastoma (GBM) is the most common form of brain cancer in adults. Glioblastoma is extremely aggressive, with disease recurring in virtually all patients and a median survival rate of ~8 months following recurrence. The currently approved standard of care has not changed in over a decade, and eligible patients are recommended to seek treatment by […]

Article

Reading Time: 3 minutesInvestigators gain deeper insights into treatment outcomes when linking their clinical trial data to real-world data (RWD) at the patient level. RWD can provide additional evidence on benefits, risks, and cost of care, ultimately accelerating patients’ access to potentially life-saving treatments while lowering the administrative and financial burden of clinical trials. To evaluate the real-world […]

Article

Reading Time: 4 minutesThis blog was authored by Kelly McKee, VP, DCTs and Patient Registries at Medidata. Despite ongoing efforts by regulators and industry stakeholders, many clinical trials continue to lack sufficient diversity, perpetuating inequitable access to novel therapeutics. Historically, trial patients have been primarily white and male, which fails to reflect real-world patient populations. Specific subgroups, such […]

Article

Reading Time: 4 minutesMedidata Solutions is excited to present three posters at the 65th American Society of Hematology (ASH) annual meeting, Dec 9–12 in San Diego, CA. The research highlights the clinically impactful results made possible by our academic-industry collaborations, and the need to continue advancing the field’s understanding of the CAR-T (and broader immunotherapy) landscape collectively. This work […]

Article

Reading Time: 3 minutes Medidata NEXT New York 2023 was an unforgettable experience that brought together 800 life sciences leaders to learn, network, and explore! NEXT featured 40+ sessions across 2 days of can’t-miss content—including keynotes, roundtables, panels, and more. Check out some of the key takeaways from the industry’s premier event. Welcoming a New Paradigm for Clinical […]

Article

Reading Time: < 1 minuteMedidata AI recently presented a research poster, “Pooled Clinical Trial Data Analyses Comparing the Biology of HER2-low vs HER2-0 Breast Cancer in Patients with Metastatic Breast Cancer Following Treatment with Standard Single Agent Chemotherapy”, at the San Antonio Breast Cancer Symposium. This study aimed to further existing research about potential differences in the biology of […]

Article

Reading Time: 2 minutes This blog was authored by Kim Worner, Global Partner Initiatives Director at Medidata. In the coming year, CROs will face a dynamic landscape with multifaceted challenges—escalating costs, scarcity of skilled professionals, regulatory changes around diversity, and questions about leveraging artificial intelligence (AI) for trials. In this setting, cutting-edge technology will play a pivotal role. So […]

Article

Reading Time: 3 minutesGenerative AI has quickly become a buzzword of 2023 because of its exponential growth and fast adoption. So far, generative AI leverages data-driven algorithms to create new content, such as text, images, audio, and synthetic data that can uncover hidden insights. These models learn from the input of information and data in which they are […]

Article

Reading Time: 5 minutesAccessing data from multiple electronic health record (EHR) systems results in challenges caused by duplication, gaps, or inconsistencies in data. The lack of standards and interoperability between EHRs and other systems in the healthcare ecosystem can have dire consequences. For example, critical information from a patient’s medical history might not be visible to hospital staff […]

Article