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How Technology Can Help ClinOps Leaders Build a Quality CultureClinical trials are time sensitive, costly endeavors with high-risk and high-expectations at every juncture.
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A Look at Independent E-Signatures to Limit the Paper Burden in Clinical TrialsAcross the pharmaceutical industry, advances in digital technology play a key role in driving the efficiency of the drug development process, particularly for clinical trials.
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Barriers to Trial Recruitment and Possible SolutionsSurvey takes deep dive into enrollment hurdles, aims to inform future recommendations for improvement.
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Models of Engagement: Patients as Partners in Clinical ResearchExploring three distinct patient partnership models to help researchers assess which methods of engagement could work best for their clinical programs.
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Barriers to Trial Recruitment and Possible SolutionsSurvey takes deep dive into enrollment hurdles, aims to inform future recommendations for improvement.
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Barriers to Trial Recruitment and Possible SolutionsSurvey takes deep dive into enrollment hurdles, aims to inform future recommendations for improvement.
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Barriers to Trial Recruitment and Possible SolutionsSurvey takes deep dive into enrollment hurdles, aims to inform future recommendations for improvement.
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Designing Alzheimer’s Disease Clinical Trials For SuccessAlzheimer’s disease (AD) is and will remain one of the most unyielding public health crises of the 21st century. Aging global populations translate to a constantly growing prevalence of a disease with no cure and an immense cost of care. In the United States alone, recent estimates1 suggest that 28 million people will develop AD by midcentury. Approximately 25% of the annual Medicare budget will be spent treating the disease – a projected $330B in 2040 – with hundreds of billions more in indirect costs.
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Site Challenges in Eastern EuropeSurvey sheds light on the regional-specific risks of managing clinical trial sites in Eastern Europe.
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Site Challenges in Eastern EuropeSurvey sheds light on the regional-specific risks of managing clinical trial sites in Eastern Europe.
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Site Challenges in Eastern EuropeSurvey sheds light on the regional-specific risks of managing clinical trial sites in Eastern Europe.
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Is a Bigger CRO Better?Much of the growth that has taken place in the top tier of CROs in recent years has been in the acquisition of some of the smaller, more innovative companies, rather than an increase in the number of compounds under study.
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The Basics of Clinical Trial Centralized MonitoringExamining the practicality of implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs.
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Clinical Trial Data StewardshipAmid the push for clinical trials to adopt more modern digital data technologies, the job of assuring adherence to key data quality and integrity principles is achievable under current regulations governing electronic record-keeping. Doing so, however, will require a new and reinvented framework: data stewardship.
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Mobile Medical Apps as Investigational DevicesConsiderations for Using a Mobile Medical App as an Investigational Device
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Mobile Medical Apps as Investigational DevicesConsiderations for Using a Mobile Medical App as an Investigational Device
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Assessing Suicidality in Clinical Trials: Paxil's Wakeup CallThe authors concluded that its secondary analysis of existing data from Study 329 demonstrated clinically significant increases in harms, including suicidal ideation and behavior (SIB) and other serious adverse events in individuals taking paroxetine.
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Equip Sites in Emerging Markets for RBMInvestigator sites in emerging markets have a different set of challenges from those in developed regions. They cater to significantly larger patient populations, and are often not as well organized for clinical trial conduct.
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Real-World Evidence StudiesReal-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization. The growing industry need for broader information on real-world effectiveness and safety-both of which will impact the eventual reimbursement and utilization of new products-is driven by regulators, public and private payers, and prescribers, all of whom seek to better understand the impact of a new product in a real-world setting. The result is that real-world evidence is now included earlier in the research and development phase.
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Real-World Evidence StudiesReal-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization. The growing industry need for broader information on real-world effectiveness and safety-both of which will impact the eventual reimbursement and utilization of new products-is driven by regulators, public and private payers, and prescribers, all of whom seek to better understand the impact of a new product in a real-world setting. The result is that real-world evidence is now included earlier in the research and development phase.
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Empower Centralized Monitoring with the Right Mix of KRI and CSM ReportsCentralized monitoring is the core of RBM and helps study teams decide on on-site monitoring activities and site intervention. Thus, the right mix of KRIs and Central Statistical Monitoring Reports is crucial for trial success.
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Expanding Data Management Services in China: Additional Insights Into a Rapidly Growing MarketEven with the rapid increase in clinical trials and demand for cloud-based systems, doing business in China is not easy if you are unfamiliar with the territory.
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Placebo Effect of Transdermal NSAIDSThe implications and challenges of the placebo effect on regulatory agency product approval.
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Risk-Based Monitoring Case Study: Lessons from a 3,389-subject Global Phase III TrialA snapshot of one novel approach in RBM implementation and the data and site performance lessons learned.
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Developing New Alzheimer’s Drugs With a Focus on Patient SafetyAligning patient-centric approaches with personalized medicine and biomarker use is transforming the design of Alzheimer's trials.
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Data Protection Regime Change in the EU: The Impact on the Pharmaceutical IndustryAlthough the devil will be in the detail of the final compromise text of the General Data Protection Regulation (GDPR), we have highlighted below how a few of the proposed changes could potentially impact the pharmaceutical industry.
