Authors
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Emerging Opportunity in GuatemalaGuatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.
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Blockchain Use in ResearchThe core tenets of blockchain technology-a decentralized and encrypted way of distributing, sharing, and storing information-seem appealing for health data.
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Are Phase III Clinical Trials Really Consistently Behind Schedule?With a unique business model, pharmaceutical companies and their subcontractors need to find every way possible to shorten drug development times consistent with patient safety. The challenges facing commercially oriented organizations developing prescription drugs are substantial.
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Panel Discussion: Merck R&D’s Digitally-Enabled Clinical Trial Team***Tuesday, January 12, 2021 at 11am EST | 8am PST | 4pm GMT | 5pm CET***Merck’s Digitally-Enabled Clinical Trial Initiative Members or “Smart Team” will discuss their experiences introducing digital technologies into the clinical trial paradigm and within their function. *** On demand available after final airing until Jan. 12, 2021 ***
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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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Emerging Opportunity in GuatemalaGuatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.
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Developing Quality BiosimilarsBiosimilars are a steadily growing new field of biopharmaceutical development and clinical research.
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Using 505(b)(2) to Solve Shortfall from Generic CliffUnderstanding the benefits of this application route in helping companies withstand the hit of patent expiries.
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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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The Virtual Organization: Is It the Future Industry Landscape?Outsourcing and data-sharing technologies are creating virtual pharmaceutical companies. Soon, you may be only as good as your network.
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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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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.
