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Regulatory Considerations Surrounding Human Challenge Studies with the SARS-CoV-2 VirusA first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.
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Optimizing Trial Supplies Via Integrated e-PlatformseGSP-driven approach focuses on overcoming operational challenges through data integration.
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eSource Records in Clinical Research: Keeping it SimpleHow to satisfy regulatory concerns about EDC data integrity and site controls over its source records.
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Optimizing Trial Supplies Via Integrated e-PlatformseGSP-driven approach focuses on overcoming operational challenges through data integration.
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Risk Assessment and MitigationA quantitative approach to enhancing risk assessment and mitigation in drug development.
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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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Europe Recruiting Additional Healthcare Teams for Specialized Rare Disease NetworksWith a month left to join one of the 24 ERNs, Peter O'Donnell writes that this initiative is a welcomed demonstration of how cooperation can function in the common interest.
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Silver Linings of Post-Pandemic Trial DisruptionThough the global pandemic that has affected millions, the industry has shown resilience and demonstrated a shared commitment to improving patient care.
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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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A Closing Thought: Prescribing Fixes for a Broken SystemArthur L. Caplan, Ph.D., chair of the University of Pennsylvania's Department of Medical Ethics, expressed his frank views about issues that are ailing the drug industry today during his DIA Keynote Address in mid-June.
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Sample Banking for Future Clinical ResearchAs the pharmaceutical industry continues to face increasing cost of drug development, sample banking for future clinical research provides the pharmaceutical industry with new opportunities to obtain biological sample collections that will allow it to investigate safety and efficacy in future clinical research and answer regulatory authority questions related to safety and efficacy at the time of registration.
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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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How to Improve Clinical Research in Children: A Survey on the Perception of European Pediatricians and Industry/CROsThe Pediatric Working Group of the European CRO Federation conducted a follow-up survey on the status of pediatric clinical trials in Europe.
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Personalized HealthcareWhat works when and for whom in the era of comparative effectiveness research.
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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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Risk-Based ApproachesThe eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.
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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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Integrating Managed Access Programs: Global ConsiderationsMAPs can effectively address unmet patient needs and become a cornerstone of product strategy.
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Warning Letter StudyAn analysis of warning letters and the findings reported from 1996 to 2010.
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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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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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Everything You Need to Know About Imaging Analytics For Clinical TrialsThe image acquisition and analysis components of R&D and clinical trials can be quite complex...
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Leveraging Technology to Bridge Clinical Trial Processes and Real-World Health CareBuilding upon the usage of technology in health care delivery, integrating technology into clinical research as a care option will be a game changer in achieving greater participation in clinical research and decreasing the overall time for trial completion.
