Authors
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Trends in Radiopharmaceuticals That May Streamline Workflows, Optimize EfficiencyEnsuring equitable access to new technologies and integrating AI to benefit all communities remain critical challenges to overcome.
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Effective eConsent Strategies for Every Study: Utilizing the eConsent Fit-for-Purpose Study FrameworkDesigning eConsent for each study from a stakeholders’ value, not technology perspective.
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Implications of the U.S. Supreme Court’s Affirmative Action Ruling for Clinical ResearchIf a future Supreme Court ruling on diversity were to be applicable to clinical research, the FDA’s positions on diversity will take on even more importance.
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Decentralized Clinical Trials: Being Audit Ready and Avoiding PitfallsSite and project management teams play major roles in risk-management and monitoring performance.
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How to Increase Engagement at Investigator MeetingsIn new age of digital, investigators must carefully create strategies to keep engagement high.
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COVID-19: A New Era for Clinical Trial Research in Europe?A look at the issues in Europe affecting ongoing trials including data management, measures being taken by sponsors, and more.
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The Only Thing Certain is the Uncertainty: How to Re-Plan Future Clinical Trial Enrollment in Covid-19 TimesSponsors need to develop a strategy on how to evaluate the impact of the pandemic on the re-start of halted trials.
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Tips and Tools to Overcome DE&I Challenges in Clinical TrialsNavigating FDA’s draft guidance and heightened diversity recommendations.
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Advancing for PatientsThis November issue of ACT explores those technological innovations in clinical trial recruitment and data collection and management that are being geared toward empowering the research community's most important asset—the patient.
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Advanced Hybrid Closed-Loop Technology Could Improve Quality of Life in Type 1 DiabetesA 1-year observational follow-up of a 3-month RCT provides insight into he benefits of advanced hybrid closed-loop system use in people with type 1 diabetes using multiple daily injections and self-monitoring of blood glucose.
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Use of Televisits in Studies and Related PV ConcernsWhile televisits can address many medical concerns, one frequent reservation expressed by healthcare professionals is that patients during these televisits tend to present too narrow a picture of their clinical condition-resulting in non-comprehensive medical assessments.
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The Strategic Emergence of Site Networks in Clinical ResearchA data-fueled framework for sponsors and CROs in navigating this shifting terrain.
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The Future of Regulatory Intelligence With Conversational AIChatbots can benefit regulatory landscape in light of evolving standards and guidelines.
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Tackling Trial Diversity Through Higher Innovation StandardsAdvancing responsible AI innovation to help resolve patient disparities.
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Examining the Current Value of ClinicalTrials.gov Listings for Patients and the PublicLooking beyond regulatory compliance.
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Trends in Patient Recruitment Advertising From 2012-2019Despite the substantial advertising dollars spent annually, patient recruitment remains one of the most difficult challenges that clinical research professionals encounter.
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Revolutionizing Oncology: Insights on the FDA’s Project Optimus and Dose OptimizationFinal guidance suggests sponsors select two doses for Phase II trials with additional data requirements.
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Why We Need to Harness Real-Time Data to Truly Drive Diversity in Clinical TrialsA look at the lessons learned from one platform approach to study enrollment tracking—and the wider quest for accountability in achieving diversity and inclusion goals.
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FDA Issues Draft Guidance on Multi-Regional Clinical TrialsMulti-region clinical trials can provide for varied results, but may not paint a full picture for a specific population.
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Oversight Method Identifies Critical Errors Missed by Traditional Monitoring ApproachesStudy Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.
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Is Japan Leading a New Digital Health Movement?Factors that contribute to Japan's prominent position in the rapidly evolving field of digital therapeutics and why it matters to the global life sciences industry.
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Why Decentralized Clinical Trials Are the Way of the FutureAssessing the opportunities, considerations and implications of decentralized trials—and why they’re here to stay
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The Future of SDTM Transformation: AI and HITLUsing an AI + Human in the Loop (HITL) approach can be utilized for Study Data Tabulation Model (SDTM) transformation, potentially alleviating current challenges
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How Sponsors Can Use Health Decision Science to Improve Clinical Trial Recruitment and RetentionExamining the behaviors of clinical trial stakeholders to better understand challenges in patient participation.
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The MDR: Navigating Europe’s New Standard for Medical Device SafetyEurope’s new Medical Devices Regulation (MDR) is four times longer than the previous Medical Device Directive, and it has raised the bar for clinical evaluations. It’s imperative that manufacturers proactively identify the gaps in their data and take the necessary steps to fill them — from pre-clinical through post-market. Many companies are unprepared for this task. Our guest, Dr. Kim van Noort, will walk us through some of the biggest challenges that MDR poses, and tell us how to overcome them.
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Future of Clinical Trial Documentation Management: eTMF Integrated with BlockchaineTMF-blockchain technology offers a myriad of application benefits to data quality and integrity while ensuring compliance to ethical standards.
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Guiding Principles for Trial Participant CommunicationNine tips to help sites close the information and understanding gaps in their dealings with patients.
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Establishing Metrics and Standardization for Non-CRF Data in EDCWhile Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.
