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TMF Reference Model Standard = Process EfficiencyOne of the many activities across the clinical development cycle that is non-negotiable is the creation, collection, management, and storage of the documents that are contained in the Trial Master File.
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Linking Leaders: Beyond the BoardroomA view on redefining key roles across the evolving clinical development landscape.
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Next-Generation Focus in Immuno-OncologyHow one biotech is tackling the unmet need for additional immunotherapies and combination approaches in cancer.
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Three-Pronged Approach to Optimizing Trial MonitoringStudy results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.
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Measurement and Analysis of Patient-Reported Outcomes to Provide the 'Patient Voice'Clinical trials today are more commonly assessing quality of life and other PRO measures as part of post-approval studies to present evidence on treatment effectiveness. It is crucial, therefore, that clinical teams have a strong plan for the capture and analysis of PROs data, and the resources required to draw clinically meaningful extrapolations.
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Developing a Logical Sourcing StrategyThe four essential steps to ensuring optimal clinical deliverable specifications and process controls.
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RBM in Late PhaseThe reality of risk-based monitoring: history and successful implementation for late phase research.
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Preserving Sight: A Deep Dive into ONL Therapeutics' Innovative Approach to Combat Retinal DiseasesIn this Q&A, David Esposito, CEO of ONL Therapeutics provides a glimpse into the company's mission, challenges, and strategies associated with clinical trials.
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Shifting the Large Simple Trials ParadigmConducting Large Simple Trials to answer questions about "real-world" medical interventions is not a recent concept.
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Sustaining InnovationConstant technological advancements continue to alter the compliance battle.
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Maximizing Oncology Imaging DataIncreasing development costs and high failure rates require earlier integration of imaging data in the Phase I setting.
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Cracking the Code on Study Start-UpNo matter how long you?ve been in the clinical trials business, the mantra is always the same: not enough investigators, not enough patients, enrollment falling behind, need for rescue sites, study budget overspend.
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Why are CRO Profits Shrinking While the Industry is Growing By Leaps And Bounds?The pharmaceutical industry continues to outsource more clinical trials to contract research organizations each year...
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5 Challenges in Site/CRO RelationshipsStrong working relationships between clinical trials sites and the CRO managing the study are critical to successfully executing a clinical trial.
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Implementation and Usage of Data Monitoring CommitteesExploring sourcing model options for appropriate incorporation of DMCs into a clinical program.
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Oversight Method Identifies Critical Errors Missed by Traditional Monitoring ApproachesStudy Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.
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Clinical Trial MobilizationWhy should sponsors and CROs consider using mobile nursing for clinical trials?
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It’s Time to Transform Clinical Trial OperationsThe need to move beyond a point-solutions approach to one built around applications designed to manage the end-to-end clinical trial process is crucial.
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European Pediatric Informed Consent and AF: Current Status of Country RequirementsThe Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.
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Risk Assessment and MitigationA quantitative approach to enhancing risk assessment and mitigation in drug development.
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Proven Methodologies Resulting in Effective and Efficient CTA ProcessThe management and oversight of clinical trials agreement contracts are still handled through spreadsheets or document management systems ill equipped for an efficient CTA lifecycle.
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Risk-Based ApproachesThe eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.
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Partnering Early for Successful Oncology Drug DevelopmentRising costs and evolving compound developments underline need for understanding at every step.
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Advancing Human Healthcare Through Accessible Trial Data and AnalyticsThe Clinical Study Data Request consortium is actively pursuing platform interoperability to allow data to be merged and analyzed as an important step for advancing human healthcare.
