Authors
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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.
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Harness Technology to Scale Global Hybrid Decentralized StudiesThe industry wide shift to decentralized clinical trials includes considerations for sponsors and CROs such as global availability, global technology, and data integration.
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Agile Drug Development’s New RealityIn order to accelerate clinical R&D and bring drugs to the market quicker, it is imperative that science is complemented by new-age technology such as artificial intelligence and data-driven smart analytics.
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Overcoming the 7 Biggest Challenges in Launching Decentralized TrialsNew era of technology brings unique obstacles.
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From Regulation to Data Aggregation: Three Machine Learning Trends to WatchFoundational issues must be addressed to advance best practices.
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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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Clinical Trial Diversity: It’s Time to Stop Talking the Talk and Start Walking the WalkThe first step is admitting there's a problem, now what will the industry do about it?
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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.
