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Accelerating Clinical Trial Design and OperationsFully-integrated, component-based CDMS offers flexibility, customization, and efficiency.
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Digital Measures of Health: What’s in it for Patients?Exploring the different stages in the development of a digital measure, and the activities and steps key to achieving meaningful impact for patients.
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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.
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A Guide to Protecting Data Integrity When Transitioning Rescue StudiesData validation, consistent communication, and meticulous documentation all keys to successfully switching CROs.
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Employing the Power of Bayesian Methods to Expedite LearningBayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research.
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Outsourcing Model Usage and its Relationship to Clinical Trial PerformancePilot study seeks to validate new and more granular outsourcing model classifications in differentiating performance across custom contract-service approaches.
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How Unified Insight Into Live Data Helped One Sponsor Succeed Where Many Others Failed***Live: Monday, December 7, 2020 at 2pm EST | 1pm CST | 11am PST***Discover how a North American pharmaceutical company succeeded where dozens of trial sponsors had failed. Leveraging innovative new clinical software, the company helped transition its breakthrough science into trial success, by delivering consistently impeccable data that accelerated the program with far less cost and effort – ultimately leading to a successful submission***On demand available after final airing until Dec. 7, 2021***
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A Look Back: How Far Clinical Trial Technology Has ComeDigitalization has revolutionized an industry once reliant on paper collection.
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An Adaptive-Block Randomization Method when Stratifying by Investigator in Small-to Medium-Sized StudiesA novel adaptive-block method of randomization to maximize the efficiency of overall treatment group balance, while maintaining balance at investigational centers in smaller sized studies, is proposed.
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Empowering Sites to Optimize Clinical Trial PerformanceSponsors and CROs can ease the burdens of patients, sites, and physicians by identifying these 3 key areas.
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Shortening Clinical Drug Supply Timelines Using AIAI can also help reduce waste from 70% to 25%.
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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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Accelerating Breakthroughs with Synthetic Clinical Trial DataThe emergence of AI-powered simulants in improving study efficiency.
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The Bridges We Must BuildImproving clinical trial diversity and health equity through strategic collaborations.
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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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The Answer to Streamlined Clinical TrialsCloud-based clinical metadata repositories can aid in accelerating clinops.
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Decibel Therapeutics case studyFounded in 2015, Decibel is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance. For this growth-stage biotech, Egnyte has been a valuable partner in supporting clinical and regulatory operations, medical writing, biostatistics and data management teams with a single repository for all documentation gathered from CROs and submitted to the FDA and other regulatory agencies.
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Overcoming the Pitfalls of Using Real-World Evidence in Regulatory SubmissionsUtilizing a broad network of provider sites is key in overcoming failure and enabling access to high quality data.
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How Digital Will Transform Product Development in 2022 and BeyondPandemic sparks new long-term plan for success in R&D.
