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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.
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Clinical Supply Capabilities, Practices, and Perceptions Among Investigative SitesPressure to shorten study start-up timelines puts clinical supply management in the crosshairs.
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Fine-Tuning CRO/Sponsor InteractionPharma needs to find a balance in working with Sponsors and CROs in order to streamline the study processes.
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The Local TouchGlobal reach for at-home study visits can accelerate clinical trials, says CEO.
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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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Observations from AACR 2014This year the AACR conference was focused on "Harnessing Breakthroughs, Targeting Cures."
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Personalized HealthcareWhat works when and for whom in the era of comparative effectiveness research.
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Sustaining InnovationConstant technological advancements continue to alter the compliance battle.
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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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Objective Internal MonitoringSponsors are responsible for monitoring studies, patient safety, and data integrity.
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State of the industry: Data & Technology in Clinical TrialsTeaming up with Eli Lilly and DrugDev Advisory Board, eyeforpharma conducted a 'State of the Industry' survey to investigate how pharma is currently leveraging data and technology and how this will change over the next 2 years. Highlights include: - Adopt a risk based approach for a cheaper way to clean your data, ensure optimum data quality and patient safety - Integrate real world and real time data for faster data generation, to quickly demonstrate value to patients and find urgent answers to unmet needs - Overcome rising R&D costs by utilizing big data to identify patient sub groups, integrate patients into research stages to better identify new biomarkers and provide more personalized treatments - See how mobile and wearable devices encourage patient participation by virtualizing parts of trials, reduce patient burden and enhance data quality
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Strengthening the Links in the Clinical Supply Chain: Aim for Transparency throughout the ProcessMost business leaders acknowledge the pitfalls of organizational silos: they breed inefficiency and signal systemic malfunctioning.
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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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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.
