Authors
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The Framework for FDA’s Real-World Evidence ProgramA look at the scope of the agency’s draft framework for evaluating the use of RWE to support new drug approvals and the implications for sponsors.
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Latin America Research StatsStarting with Eastern European sites in the 1990s, companies have increasingly selected investigator sites outside of North America and Western Europe.
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Antimicrobial Resistance and the Role of VaccinesAntimicrobial resistance remains a health and financial danger worldwide. Vaccines can both help reduce disease and combat antimicrobial resistance. Despite advancements, making antibacterial vaccines remains challenging.
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Portfolio Approach to Optimize Site SelectionOptimization model evaluates the benefits of selecting a portfolio of investigative sites based on advanced analytical models.
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Simulation Model for Productivity, Risk and GDP Impact Forecasting of the COVID-19 Portfolio VaccinesPortfolio simulation may be an effective tool to forecast achievability of COVID-19 portfolio strategic goals, including risk mitigation to boost vaccines development and production.
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Finding Ways to Finance the Growing Costs of Clinical TrialsOver the past few months the majority of the news coming out of the pharmaceutical industry has been a refrain of slashing R&D spending as a result of increasingly competitive drug development.
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Categorical Data AnalysisA review of different statistical methods for data types and models used during research.
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The Patient Perspective on Clinical TrialsSurvey uncovers deeper learnings of patient perceptions of clinical research and the motivations to participate.
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The Patient Perspective on Clinical TrialsSurvey uncovers deeper learnings of patient perceptions of clinical research and the motivations to participate.
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Free-to-Use eLearning ModulesApart from training and certifying individual EC members, the Dutch Central Committee on Research involving Human Subjects (CCMO) recently added training of investigators to its repertoire.
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Lifecycle Modeling and Simulation in Clinical TrialsHow the application of evolving M&S models are transforming full-research design strategies.
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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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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.
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.
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.
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.
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.
