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Considering Patient Burden in OncologyImplementing new strategies with the use of patient-reported outcomes.
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Virtual Medical Affairs Audits: A Viable AlternativeVirtual audits proving to be beneficial post-COVID despite continuing challenges.
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Facilitating Adoptive Cell Therapy Clinical TrialsEvolving technologies include modification of receptors on T cells to better target tumor microenvironments and minimize off-tumor cross-reactivity.
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eCOA Studies: Tackling the Barriers to Adopting ‘Bring Your Own Device’ StrategiesAn increasing number of patients report looking for more simplicity and less burden related to a clinical trial, and a "bring your own device" option is one of the ways to meet this need
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Clinical Study Audits: The Quality Management ApproachAdvancing risk-based auditing one step further by identifying the underlying process deficiencies to enable improved corrective and preventive actions.
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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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Bringing AI Out of the Shadows and into the Physical World of Drug DevelopmentWhile many groups rely on manual chemistry processes, innovative platforms have emerged that allow these protocols to be executed on custom automation systems.
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The Use of Artificial Intelligence in Clinical Trial EnrollmentIn an interview with Applied Clinical Trials Associate Editor Don Tracy, Sonia Lwoff, director, clinical operations, Rho, discusses the potential for artificial intelligence in clinical trial decision-making and enrollment.
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Facilitating Adoptive Cell Therapy Clinical TrialsEvolving technologies include modification of receptors on T cells to better target tumor microenvironments and minimize off-tumor cross-reactivity.
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The Current Status of European Research Related to COVID-19: The EUCROF PerspectiveSuccessful collaborations between Pharma/Biotech/Device industries and CROs will play a key role in an effective fight against the global COVID-19 pandemic.
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Preparing for Pivotal: Solving Challenges in Scale for Cell and Gene Therapy Clinical TrialsTuesday, June 22, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
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Sticking to the Plan: Undue Burden Created by Protocol DeviationsMinimizing protocol deviations is a simple, yet effective way for sites to keep trials patient-centric.
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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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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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AI Adoption for Clinical Trial Design, PlanningAn overview of the advantages of implementing AI into clinical development and the obstacles that prevent its widespread adoption.
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Master Protocols: Implementing Effective Treatment Adaptations in the RandomizationIt is unrealistic to include infinite adaptations in an IRT system, thus identifying the optimal level of adaptations requires examination of the study’s characteristics and planning phase considerations.
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COVID-19 Will Have a Heterogeneous Impact on Clinical Trials, BiopharmasA discussion of how the coronavirus pandemic will have a multitude of impacts on the conduct of trials, as well as on the industry itself.
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The EU Regulations Catching US Pharma Companies Off GuardCompanies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.
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Towards a Global Implementation of eConsent in Clinical TrialsAll stakeholders must play part in increasing implementation.
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Diversity and Inclusion in Clinical Trials: Tangible Progress and Strategies for the FutureThe clinical research industry is increasingly leveraging insights, experience, and advanced solutions to better implement diversity and inclusion initiatives.
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AI Already Starting to Deliver Faster, Safer, More Effective Clinical TrialsFrom design and trial start-up to conduct and analysis, there is enormous potential for applications of artificial intelligence within clinical trials to have a profound impact on human health.
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Accelerated Approval and the Promise of Gene TherapyExploring the implications of FDA’s renewed focus and commitment to expand the use of accelerated approval for gene therapy products.
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How to Improve Quality of Study Delivery? Work with Technology-enabled SitesPractical ways CROs and sponsors can support sites and improve quality.
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Five Key Considerations for Designing and Implementing Decentralized Clinical TrialsStrategies and considerations for adopting decentralized clinical trials.
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Thinking Big for Small and Mid-Sized Biotechs: How Applying Modeling Technologies Can Improve Drug DevelopmentAllucent’s Katy Moore, Pharm. D., R.Ph. President, Clinical Pharmacology Modeling and Simulation, offers insightful commentary for small and mid-sized biotechs developing scientific breakthroughs. Learn from Katy’s expertise how applying modeling and simulation can improve drug development and help bring new therapies to light.
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Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.
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The Impact of Trial Design on Interest by Race and EthnicitySurvey examines trial enrollment motivation among diverse populations.
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Clear Scope of Work Specifications Makes for Strong CRO/Sponsor PartnershipsTo optimize the Sponsor/CRO relationship, the final proposal must represent a win for both parties.
