Authors
Latest:
A New Approach to Temperature Monitoring in a Changing Clinical Supply Chain EnvironmentExamining the implications of shipping temperature-sensitive clinical supplies in an evolving clinical supply chain, including shipments direct to patient homes (DTP) and the need for temperature monitoring thereof.
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Introducing PALADINFirst-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.
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The Rise of Shared Digital Health Economy and Promise of Accelerated Clinical ResearchPatient advocacy organizations are swaying away from a traditional model of granting academic researchers to now supporting biotechnology and pharma companies.
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Importance of Diversity in Parkinson’s ResearchEliminating barriers to engage underrepresented populations.
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Developing a Logical Sourcing StrategyThe four essential steps to ensuring optimal clinical deliverable specifications and process controls.
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The Evolution of Patient-centric Technology for Clinical ResearchA look at what patient centricity in clinical research means and how it has evolved.
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Do Oncology Clinical Trials Need PR?Designing protocols to maintain a trial's validity while enabling seriously ill and informed participants to receive both SOC and investigational products will help to improve patient participation in oncology clinical trials.
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RAPS Statement - BREXIT delayRegulatory Affairs Professionals Society's Executive Director, Paul Brooks, discusses the looming uncertainty about what will happen after the UK leaves the European Union as many important details remain unclear.
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Work Planning & Approaches to Overcome BottlenecksOutlining a resource planning and scheduling model, using the example of an analytical department in drug development.
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Moving Clinical Operations Forward During PandemicLockstep with regulatory guidance on conducting trials amid crisis, here are four key actions sponsors can take to minimize disruptions.
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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.
Latest:
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.
