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At-home Self-collection of Blood Specimens for Safety Lab Testing in Clinical Trials via the Tasso+ DeviceLaboratory services organization focuses on easing patient and site burden with improved collection device.
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FDA Patient-Focused Drug Development Guidance Update: Incorporating Patient Experience Data in Clinical TrialsThe four new methodological Patient-Focused Drug Development guidance documents the FDA is currently developing for the industry that incorporate patient experience data into drug development, summarized.
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Considerations to Reach Underrepresented GroupsRegulatory compliance, collaboration, and effective use of technology among ways CROs can overcome challenges.
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Why Wearable DHTs are Bringing More Meaningful Data Collection to Patient-Centric Clinical TrialsWearable digital health technologies can enhance traditional clinical outcome assessments, such as for neurology, pulmonology, cardiology, and rheumatology.
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EU Perspectives: Guidance for Using Patient Experience Data in Real-World StudiesPatient insights are expected to become increasingly instrumental in optimizing medicine development and regulatory decision-making.
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Bridging the Gap Between Clinical Trial Stakeholders and PatientsNew online platform, Clinical Trial Guide seeks to improve access.
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Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 WorldRecognizing pre-pandemic pain points, such as patient engagement and protocol development, could lead to post-pandemic trial success.
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The Evolving Role of AI in Shifting the Bottleneck in Early Drug DiscoveryTesting in humans in clinical trials and the regulatory approval process itself are candidates for technology solutions where artificial intelligence is playing a role.
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Osteoarthritis: Is a Cure on the Launch Pad?Common advice for OA sufferers is joint replacement, but other options are on the horizon.
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Establishing a Basis for Secondary Use Standards for Clinical TrialsStudy seeks to understand how different forms of data meet the needs of researchers.
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Harness Technology to Scale Global Hybrid Decentralized StudiesThe industry wide shift to decentralized clinical trials includes considerations for sponsors and CROs such as global availability, global technology, and data integration.
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Agile Drug Development’s New RealityIn order to accelerate clinical R&D and bring drugs to the market quicker, it is imperative that science is complemented by new-age technology such as artificial intelligence and data-driven smart analytics.
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Overcoming the 7 Biggest Challenges in Launching Decentralized TrialsNew era of technology brings unique obstacles.
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From Regulation to Data Aggregation: Three Machine Learning Trends to WatchFoundational issues must be addressed to advance best practices.
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Real-World Use of an Artificial Intelligence-Supported Solution for Coding of Adverse Events in Clinical TrialsStudy evaluates the use of AI-supported medical coding module.
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Clinical Trial Diversity: It’s Time to Stop Talking the Talk and Start Walking the WalkThe first step is admitting there's a problem, now what will the industry do about it?
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Accelerating Clinical Trial Design and OperationsFully-integrated, component-based CDMS offers flexibility, customization, and efficiency.
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Are Any Data in Clinical Trials Better than No Data At All?The answer comes down to context of use—and knowing the motives for "missingness."
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Decentralized Clinical Trials: What Therapeutic Areas are Ripe for All-Virtual?Five therapeutic areas that are apt for an all-virtual approach, and that can serve as an entry point for sponsors who are hesitant yet interested in exploring the growing DCT model.
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Data Integration Strategy: The Cornerstone Of A Successful Regulatory SubmissionThe data, not the plan, provide the direction.
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Unstructured Patient Diaries: To be, or not to be, that is the QuestionWhether unstructured patient diaries will be part of future clinical trials depends on three main factors, including answers around added value.
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Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce2020 Tufts CSDD study examines relationship between investigative site personnel diversity and study participant diversity.
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Optimizing Clinical Trial Efficiency: The Power of Simplicity for First-in-Human StudiesHow industry can increase the speed of these trials while continuing to meet patient needs.
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Importance of Diversity in Parkinson’s ResearchEliminating barriers to engage underrepresented populations.
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Assessing Sponsor Attitudes Toward Retail Pharmacy Involvement in Clinical Trial Recruitment and ExecutionAmid CVS’ surprise exit from the clinical research space and the ensuing broader questions, study investigates the benefits of pharmacy chain involvement—along with the concerns and barriers to adoption.
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Adapting Site Selection for Clinical Trial Decentralization and the Future LandscapeSites not expected to fade away even as DCTs continue to grow past COVID-19.
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Key Points to Success in Decentralized Alzheimer’s Diagnostic Clinical TrialThis article highlights how C2N Diagnostics and Firma Clinical Research teamed up to create a successful Alzheimer's diagnostic clinical trial while allowing participants to remain in their homes.
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Rethinking ECOG Scores to Improve Patient Access and Clinical Trials EligibilityRecent study results highlight need for new metrics in ECOG scoring to mitigate variability.
