Authors
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New Regulations for Medical Devices in IndiaSudhakar Bangera and Latha MS discuss how in the past medical devices in India were clubbed with regulations for new drugs, biologicals and vaccines, but how new regulations are bringing new and more devices to the area.
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New Regulations for Medical Devices in IndiaSudhakar Bangera and Latha MS discuss how in the past medical devices in India were clubbed with regulations for new drugs, biologicals and vaccines, but how new regulations are bringing new and more devices to the area.
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A Movement in Diabetes: Using Time-in-RangeLearn how the diabetes management space is evolving with new metrics such as time in range (TIR), time below range (TBR) and time above range (TAR) growing prominence and the potential benefits that can be achieved by improvements in these metrics Live: Thursday, Dec. 12, 2019 at 11am EST On demand available after airing until Dec. 12, 2020. Register free
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Implementing RWE to Advance Innovative MedicineDrug development in oncology continues to evolve, Sarah Alwardt, VP of Data, Evidence, and Insight Operations for McKesson, discusses the shift to highly personalized therapies, including new modalities like cell and gene therapies.
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GlaxoSmithKline Tackling Data Challenges to Streamline Drug DevelopmentAt some point in every organization’s life, they come to realize that their data environment isn’t set up for success. Adrian Cottrell, PhD, VP of clinical, medical, and regulatory tech for GlaxoSmithKline writes about when his company came to that very conclusion in 2017.
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Research in the United KingdomThe current initiatives and a historical overview of the clinical trial landscape.
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What’s Next for Drug Validation in the Age of Precision Medicine?The case for evaluating drugs with real-world digital health data.
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What’s Next for Drug Validation in the Age of Precision Medicine?The case for evaluating drugs with real-world digital health data.
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What’s Next for Drug Validation in the Age of Precision Medicine?The case for evaluating drugs with real-world digital health data.
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What’s Next for Drug Validation in the Age of Precision Medicine?The case for evaluating drugs with real-world digital health data.
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Tackling the Challenges of Transitioning to RBMMethods sponsors and CROs can use to minimize the growing pains associated with RBM implementation.
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Tackling the Challenges of Transitioning to RBMMethods sponsors and CROs can use to minimize the growing pains associated with RBM implementation.
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ePRO Not Profitable? Consider a Revenue-Generating Delivery ModelKyle Hogan, Director, eClinical Solutions, Clinical Ink, writes how however promising ePRO may be - its benefits may not be enough to overcome concerns that take an significant period of investment before generating business, patient benefits, and financial returns.
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Randomization Revolution is BrewingSystems that support automated processes have begun to transform the conduct of clinical trials.
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The Cancer Trial Paradox: Too Few Patients to Some, Too Few Trials to OthersWhile obstacles may persist with limited access for patients and researchers, technology can help with this cancer clinical trial paradox.
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Master Protocol Guidance in Cancer R&D: Impact on IndustryFDA draft guidance for modernizing the approach to clinical trial design for oncology drugs and biologics look to make clinical trials more efficient while maintaining patient safety.
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The Importance of Site SelectionCase study focused on quest for potential Parkinson’s biomarker highlights opportunities and challenges in site selection.
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Clinical Data Manager: A Roadmap for the FutureBreaking down the evolving role of today’s clinical data manager-and its importance as a key cog in the clinical research ecosystem of tomorrow.
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Risk-Based Quality Management: The Importance of Risk CommunicationAmid the recently released ICH E8 (R1) draft guidelines further supporting RBM strategies, practical methods for integrating critical-to-quality (CTQ) factors within the operational execution life cycle of a clinical trial are presented.
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How to Address—and Overcome—Operational Challenges in Master Protocol StudiesTrials that address multiple questions simultaneously using a master protocol can be operationally complicated. These complexities can be managed, even in studies used to support a marketing application.
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Technology-Based Patient Focus to Improve Clinical TrialsExploring ways technology can help sponsors improve their outcomes, focusing on the essential but often-undervalued player in clinical research: the patient.
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To Extrapolate Site Enrollment or Not To Extrapolate? That is the Question.Analysis of over 330,000 Phesi trial protocols shows predicting future enrollment performance by extrapolating data is flawed.
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The Well-Adjusted Statistician: Analysis of Covariance ExplainedHow to account and adjust for covariates in clinical trial randomization-and be confident about uncertainty.
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The Case for Response Adaptive Trial Design for Rare DiseasesAs pharma businesses shift their focus away from ‘blockbusters’ to treatments for rare diseases, clinical trial design must also go through a period of change and should consider response-adaptive over traditional randomized controlled trial designs.
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Moving From Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research ProfessionalMedicines development and clinical research are among the most heavily regulated activities on a global basis.
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MyStudies Platform Brings Patient Experience to Drug DevelopmentMyStudies, introduced by the FDA, bridges data streams to real world evidence by facilitating the collection of real-world data directly from patients in conjunction with a variety of data sources.
