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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.
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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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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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Considerations to Reach Underrepresented GroupsRegulatory compliance, collaboration, and effective use of technology among ways CROs can overcome challenges.
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Clinical Strategies to Optimize Software as a Medical Device to Treat Mental HealthWith close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.
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Why Wearable DHTs are Bringing More Meaningful Data Collection to Patient-Centric Clinical TrialsWearable digital health technologies can enhance traditional clinical outcome assessments, such as for neurology, pulmonology, cardiology, and rheumatology.
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EU Perspectives: Guidance for Using Patient Experience Data in Real-World StudiesPatient insights are expected to become increasingly instrumental in optimizing medicine development and regulatory decision-making.
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Bridging the Gap Between Clinical Trial Stakeholders and PatientsNew online platform, Clinical Trial Guide seeks to improve access.
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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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The Evolving Role of AI in Shifting the Bottleneck in Early Drug DiscoveryTesting in humans in clinical trials and the regulatory approval process itself are candidates for technology solutions where artificial intelligence is playing a role.
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Osteoarthritis: Is a Cure on the Launch Pad?Common advice for OA sufferers is joint replacement, but other options are on the horizon.
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Establishing a Basis for Secondary Use Standards for Clinical TrialsStudy seeks to understand how different forms of data meet the needs of researchers.
