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Relying on Data and Behavior Science to Unlock Real ChangeWhat small “nudges” can serve as reminders and relevant motivators to help patients meet their goals, talk to a physician, explore a clinical trial, or stick with a treatment?
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Primed for Progress: FDA’s Pre-Cert Program for Digital Health DevicesExecutives from DIA, Ranjini Prithviraj and Sudip Parikh discuss documents the FDA released that further detail the agency’s implementation plan for its Software Precertification Pilot Program.
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Primed for Progress: FDA’s Pre-Cert Program for Digital Health DevicesExecutives from DIA, Ranjini Prithviraj and Sudip Parikh discuss documents the FDA released that further detail the agency’s implementation plan for its Software Precertification Pilot Program.
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Managing Clinical Trial Complexity as Gene Therapy ProgressesThe history of gene medicine is filled with hope, tragedy, and successes. VP of Rare Diseases & Pediatrics for Premier Research, Angi Robinson, writes how patient well-being must always prevail, and challenges mustn’t stop us from helping solve unmet medical needs.
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The Transformation of Clinical Trials from Writing on Papyrus to the World of TechnologyNew requirements must be put in place to ensure data quality and integrity.
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Advantages of Outsourcing IRB & IBC ReviewsSeeking faster startup for cell and gene therapy studies? Sponsors can streamline IRB and IBC reviews by coordinating the committees’ activities via a vendor offering both resources in-house.
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A Roadmap for Implementing RBM and Quality ManagementThe importance of applying change management techniques throughout the preparation, planning, and execution of RBM and RBQM approaches.
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A Roadmap for Implementing RBM and Quality ManagementThe importance of applying change management techniques throughout the preparation, planning, and execution of RBM and RBQM approaches.
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A Roadmap for Implementing Risk-Based Monitoring and Quality ManagementIntegrating a systemic risk management strategy for identifying clinical trial risks-and the importance of applying change management techniques throughout the preparation, planning, and execution stages.
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Clinical Research as a Care Option: Optimizing ApproachesExamining the fundamental changes required to successfully integrate clinical research into mainstream healthcare.
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Re-Imagining Integration for Quality Clinical TrialsVice President of Global Technology and Product Management, Chris Dailey, and Enterprise Architect at Cenduit LLC, Chris Driver, encourage all sponsors and CROs to take a strategic view of how to make an eClinical ecosystem function at its highest level.
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Re-Imagining Integration for Quality Clinical TrialsVice President of Global Technology and Product Management, Chris Dailey, and Enterprise Architect at Cenduit LLC, Chris Driver, encourage all sponsors and CROs to take a strategic view of how to make an eClinical ecosystem function at its highest level.
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Turn to ClinRegs for International Clinical Research RequirementsAfter launching as a free online resource for country-specific, clinical research regulatory information in 2014, ClinRegs has grown to over 68,000 users from 157 countries.
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Turn to ClinRegs for International Clinical Research RequirementsAfter launching as a free online resource for country-specific, clinical research regulatory information in 2014, ClinRegs has grown to over 68,000 users from 157 countries.
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Turn to ClinRegs for International Clinical Research RequirementsAfter launching as a free online resource for country-specific, clinical research regulatory information in 2014, ClinRegs has grown to over 68,000 users from 157 countries.
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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.
