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Evolving Tools and Perspectives for the Development of Cell and Gene TherapiesStakeholders must alter their mindsets when it comes to early-phase design and interpreting regulatory guidance for CGT trials.
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Applied AI and Advanced Automation in Clinical TrialsUse cases spotlight the growing potential of generative AI in the CRO space.
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Scaling eSource-Enabled Clinical Trials: Hospital PerspectivesThe challenges, opportunities, and strategic outlook for oncology research centers.
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Self-collection of Blood Specimens in Clinical TrialsOperational and patient burden considerations for self-collection of blood specimens in clinical trials
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Cancer Won’t Wait for COVID to End: Conducting Trials Amid the Coronavirus PandemicThousands of trials have been halted as a consequence of the coronavirus pandemic, slowing the pace of scientific progress dramatically.
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5 Reasons Physicians Should Integrate Clinical Trials Into Their PracticeUsing IROs can offer the opportunity for doctors to incorporate clinical research as a care option in their practices.
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Streamlining Clinical Trials: Mitigation and ManagementHow service providers are helping to accelerate drug development.
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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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What Do COVID-19 Vaccine Timelines Mean For Clinical Development?The pandemic spurred an urgency to innovate that improved clinical development in ways that should benefit the industry beyond COVID-19.
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Towards a Global Implementation of eConsent in Clinical TrialsAll stakeholders must play part in increasing implementation.
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America’s Vanishing Scientific Research Workforce is a Threat to Public HealthAs biotech innovation accelerates, the clinical research workforce is rapidly eroding—threatening the future of drug development. From workforce burnout to training program cuts and talent pipeline collapse, clinical trial professionals must confront this escalating crisis head-on to sustain progress and protect public health.
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Creating Strategic Relationships: The Changing Face of Contract Research Organizations and Sponsor PartnershipsBy taking on tasks such as clinical trial management, logistics, statistics, and data management, contract research organizations have helped expand the capabilities of their sponsor partners and accelerate drug development timelines.
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Helping Rescued Adjudication Committees Get Back on TrackDetermining if an EAC is at risk and key actions to mitigate trial impact.
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Where Innovation and Patients Meet to Improve Cancer CarePromising scientific advances are pacing oncology drug development.
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Clinical Trial Monitoring: Should Randomization Be Included?While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.
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Changing the Paradigm in AI ImplementationHow pharma companies can reduce the risk of failure with AI-based innovations.
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FDA’s New Diversity Plan Guidance, And What It Means for Sponsors Developing Cancer DrugsGuidance will compel sponsors to consider new enrollment strategies and to be more diverse.
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Community Pharmacies Can Help Bridge the Diversity GapThrough grassroots patient education, local pharmacies serve as a pivotal doorway to improving access to trials.
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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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Clinical Trials and TrustUnderstanding the role of social determinants on clinical trial participation and trust.
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Establishing Metrics and Standardization for Non-CRF Data in EDCWhile Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.
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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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Direct-to-Patient: At-Home Clinical Trials Are Here to StayThe success of the decentralized model hinges on coordination between stakeholders across the supply chain to ensure that date is secure, medication is delivered on time, and in proper condition.
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Prioritizing Patients: Strategies and eCOA Best Practices in Drug DevelopmentA more user-centered design can allow increased flexibility in the development of eCOA platforms, driving better engagement and participation.
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Changing the Digital Health Playing Field: A New EraMoving beyond the pill to extend the value being delivered to patients.
