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Risk Assessment and MitigationA quantitative approach to enhancing risk assessment and mitigation in drug development.
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Understanding FDA’s Perspective on Precision DosingContinued embrace of precision dosing will reduce costs and optimize clinical outcomes.
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Drivers of Patient Interest in ReferralAnalysis suggests age, condition, and treatment satisfaction have most significant effect on participation.
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What We Can Anticipate from TransCelerateThe somewhat-awkwardly named TransCelerate BioPharma immediately got an enthusiastic reception from industry watchers and participants, mainly due to the perception that it was well poised to attack some of the systemic causes of delays and cost overruns that plague clinical trials today.
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ePRO Industry GrowthA countdown of the top 10 developments that have most influenced the ePRO industry over the past decade.
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Comparing the Five Methods to Collect Patient-Driven eDataThe specialized industry of collecting patient-driven eData is increasing exponentially. Patient-driven eData encompasses all electronic clinical outcome assessments - or eCOAs -- including patient reported (PRO), clinician reported (ClinRO) and observer or caregiver reported outcomes (ObsRO).
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PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
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Site-Driven MetricsThe clinical trials industry can benefit from site-driven metrics for process improvement and site scoring.
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Social Media RecruitmentThe opportunities and challenges social media provides in the realm of subject recruitment.
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Emerging Opportunity in GuatemalaGuatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.
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Demonstrating Biosimilarity: PK ConsiderationsProving a biosimilar's pharmacokinetic 'equivalence' requires adherence to several unique factors.
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Best Practices in Study FeasibilityThis Best Practice in Study Feasibility report covers techniques and innovations proffered by sponsors and CROs for conducting feasibility analyses.
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PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
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Using Public and Private Data for Clinical OperationsComparing mean vs. median to uncover the full data picture of site-level performance.
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PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
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Understanding Non-AdherenceInappropriate calendar pacakaging is a common occurrence leading to confusion and mistakes.
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Emerging Opportunity in GuatemalaGuatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.
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Risk Assessment and MitigationA quantitative approach to enhancing risk assessment and mitigation in drug development.
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Planning for Success: Global Oncology TrialsMany pharmaceutical, biotechnology and medical device companies have adopted globalization as a business model for their clinical trials. This model is especially pertinent within oncology with the number of competing trials consistently rising while patient access across North America and Western Europe has plateaued. While this geographic diversity of oncology trial sites has potential to open future markets, it also adds logistical hurdles ranging from import and export licenses to regulatory approval to variances in standard of care. This white paper explores several of the areas critical to the success of global oncology trials, including study planning, conducting feasibility and navigating regulatory submissions.
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Tailored Latino RecruitmentSurvey results show that the recruitment of Latino subjects requires specialized tactics.
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PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
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How to Address—and Overcome—Operational Challenges in Master Protocol StudiesTrials that address multiple questions simultaneously using a master protocol can be operationally complicated. These complexities can be managed, even in studies used to support a marketing application.
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PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
