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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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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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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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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.
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Increased Digitization in Clinical Trials: Expectations for the Year AheadTop predictions for the major trends that will shape clinical trial design in 2022.
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Early Protocol Assessment for Increased Patient CentricityHow novel clinical trial designs can help minimize patient burden.
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Harnessing Unstructured Data and Hospital InteroperabilityThe potential of next-generation platforms in transforming patient recruitment.
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Compliance Amid the ‘Great Resignation’Minimizing impacts through focus on employee wellness.
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Four Key Trends for Identifying Regulator and Payer Evidence Needs in Oncology Drug DevelopmentHow to leverage novel trial designs and real-world data to support a cancer drug submission with an evidence strategy that is both approvable and reimbursable.
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Rate of Patient Recruitment to International Multicenter Clinical Studies in Eastern Europe CountriesThe success of a clinical study depends on the possibilities to involve the patient in the study.
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Getting the Most From FSP ModelExamining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas.
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Getting to Clinical Trial DiversityDiffering levels of trust in clinical trials information channels across diverse populations is examined in this research.
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How to Determine ‘Good Science’ for Systematic Literature Reviews in Clinical Research and DevelopmentBest practices for assessing publications.
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Currency of Patient Engagement: Changing TidesMeeting patients at the point of care can increase trust and engagement.
