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Righting the Ship in 2024 and Beyond: Navigating the First Extended Workforce Recession in the History of the Life Sciences IndustryWebinar Date/Time: Tue, Tue, Nov 28, 2023 11:00 AM EST
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COVID-19 and Its Impact on the Future of Clinical Trial ExecutionFindings from a Tufts study examining the effects of COVID-19 on clinical trials.
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FDA Finalizes Decentralized Clinical Trial GuidanceThe FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
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Defining Quality Tolerance Limits and Key Risk Indicators that Detect Risks in a Timely Manner: Reflections from Early Adopters on Emerging Best Practices (Part 3)Series Part 3—Methods for early detection of risk and summary.
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A pathway for replacing costly TQT studiesBolstered by the recently approved S7B/E14 Q&A document, early-stage concentration-QTc analysis is emerging as a standard for assessing cardiac safety.
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Accelerating Research Site OperationsLessons learned during the pandemic from University of Louisville.
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COVID-19 Pandemic Exemplifies the Benefits of CROsThe adaptability and innovative capacity of CROs highlighted in EUCROF survey.
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The Argument for Data Alignment and Integration in Clinical Supply ManagementSiloed systems can make it difficult to marry data to support timely and informed decision-making and optimize clinical trial operations.
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Leveraging Lessons Learned From the First Decade of Modern Immuno-OncologyWhich new developments can help jump-start breakthroughs in immuno-oncology research? Understand the key scientific drivers, read peer-reviewed research, and get actionable ideas that can spur innovation in this must-read paper for clinical leaders.
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Consequences of Brexit for Clinical Trials in EuropeHigher costs headline list of new challenges faced by CROs and sponsors.
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The Role of Transferable Skills and Data Science in the Move to Digitally-Enabled Clinical ResearchSimultaneous and niche skills sought amid evolution in clinical data management.
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Combating the ‘Talent Wars’ in BiopharmaCompetency-based and other creative approaches are needed to address the battle for talent in the clinical research workforce.
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Winning the Competition for Clinical Sites By Reducing Site User BurdenWith the number of clinical trials and sponsors increasing every year, meeting enrollment requirements and timelines becomes harder and harder. Please join Almac Clinical Technologies and Exostar as they discuss solutions to attract and retain the right resources to meet your requirements and timelines. Live: Thursday, Aug. 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Aug. 27, 2021.
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Reducing Patient Dropout Rates and Accelerating Trial CompletionJon Ernst (Vice President, In-Home Solutions, Decentralized Clinical Trials) discusses today's clinical trial landscape.
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The impact an eClinical Supply Chain Management platform can have on your next clinical trialSponsors and CROs have historically been responsible for ensuring full chain of custody for their own clinical supply even though the clinical supply is typically outside of their control. It is the burden of the Sponsors and CROs to determine the most efficient way to do that. An eClinical Supply Chain Management platform provides Sponsors and CROs with the assurance that they are meeting their regulatory requirement of full chain of custody and more importantly ensures that all needed clinical supplies are available and all samples get where and when they are needed.
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Harmonizing Outsourcing to Keep Clinical Trials on TrackA shared partnership culture is critical in navigating today’s complex terrain.
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Navigating the Future of Decentralized Clinical TrialsAlthough executive enthusiasm for decentralization of clinical trials has grown significantly, operationalizing these models requires meticulous planning and risk-based quality management.
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Modernizing Patient-Reported Outcomes: Bridging the Gap Between Legacy Measures and Contemporary HealthcareStrategies for ensuring that innovation with PROs remains parallel with advancements in disease detection and progression.
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A Market Failure for Antimicrobial Resistant MedicinesWhile the world focuses on COVID-19, this article provides insight on the current state of the market for antimicrobial resistant (AMR) medicines.
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Challenges in Conducting Multicentric Infectious Giardia Diarrhea Clinical Studies in IndiaMulticentric studies on diarrhea are essential for comprehending its epidemiology, causes, and treatment outcomes.
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Oncolytic Virus Immunotherapy: A Brief Overview and Considerations for Clinical Trial PlanningSuccessful oncolytic virus immunotherapy clinical development requires unique features that focus on viral biology and host immune response.
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Clinical Trial Matching Solutions: Understanding the LandscapeA framework to understand the different approaches of trial matching solutions and the major operational and workflow challenges that all matching solutions share.
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Phase III SELECT-GCA Trial Results Lead to FDA Approval of Rinvoq for Giant Cell ArteritisRinvoq (upadacitinib) becomes the first oral JAK inhibitor approved by the FDA for the treatment of giant cell arteritis in adults, following robust data from the Phase III SELECT-GCA trial demonstrating its efficacy in achieving sustained remission and reducing glucocorticoid exposure.
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Workforce Trends in Drug DevelopmentTufts CSDD study breaks down state of the talent pipeline from lens of senior leaders.
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Accelerate Inclusive Enrollment and Delivery with LightshipDavid MacMurchy, Chief Executive Officer at Lightship, offers some insights into the company's mission toward improving equity and diversity in clinical trials.
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De-Risking Trials with Science-Driven OversightIdentifying the ‘significant six’ areas of clinical study conduct to mitigate risk.
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When Should the Audit Trail Begin?A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
