Authors
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COVID Challenges for Trials in Low-to-Middle-Income CountriesOutlining the five critical hurdles faced by clinical teams conducting studies in these nations amid quarantine and other restrictions.
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10 Questions to Consider With eTMF Vendor SelectionThe many different shapes and sizes of vendors requires a thoughtful process for selection.
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How NLP, OCR, and Social Graphs Accelerate Subject Recruitment for Clinical TrialsExplore how natural language processing and social graph techniques help to tackle the challenge of patient and investigator recruitment and raise the success rate of clinical trials.
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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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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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Using Real-World Data in Patient RecruitmentGrowing availability of RWD leads new drug development process.
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Solutions to Accelerate Data-Driven Chemicals and Materials InnovationTeams need to keep close track of ingredients, processing parameters, and material performance so that they can use their R&D data to decide exactly which materials to make next.
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Evaluating Global Regulatory Landscape for Driving Digital Innovation in Supply ManagementRecent updates from regulatory bodies are providing more confidence in integrating different forms of trials and technology.
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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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Executing Trial Design With Patients—Not For PatientsApproaching protocol design and operational planning with patient empathy.
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Importance of Diversity in Parkinson’s ResearchEliminating barriers to engage underrepresented populations.
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FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug DevelopersJanuary 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.
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What the Future of Study Review Processes Should Look LikeInsights from Bayer’s study review process showcases importance of incorporating feedback from a wider audience of stakeholders.
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Generational Differences Among African Americans, Their Experiences with the Healthcare SystemA study exploring healthcare preference and experience in this population group uncovers new insights and opportunities related to clinical research participation.
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Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial DataPresenting how data transformation is measured as part of the SAFE Data Standard, which data variables influence the rating and, how the appropriate level of data transformation is calculated.
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Clinical Trials Diversity and InclusionChairman and Founder of MJH Life Sciences, Mike Hennessy Sr. explores the main discussion points covered in the June issue of ACT.
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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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Effective regulatory strategies for rare diseaseIn the rare disease issue of New Medicines, Novel Insights from Parexel, experts and former regulators share insights for developing effective regulatory strategies earlier.
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Targeting Patient PopulationKeys to ensuring your clinical trials better reflect your target population.
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Budgets and Billing in Clinical Trials: DCT ConsiderationsCost strategies for medical device trials in the new era of digital health.
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Precision Medicine in Clinical Trials: Adapting to the New Demands of Clinical Research TodayWebinar Date/Time: Thursday, May 25th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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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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Post-Pandemic: An Argument for Protocol SimplicityWhat does the industry have to lose in pursuing a more straightforward path?
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AI/ML Approaches to Assisted Medical Writing—Part 2Following a discussion around summarization in Part 1, Part 2 discusses the method of pure abstraction in light of recent advances in deep learning and AI.
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Breathing New Life into Respiratory Clinical Trials with Digital BiomarkersIncreased data output from the use of devices can accelerate trials for this therapeutic area in need of new therapies.
