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The Benefits of Advanced Imaging Management SystemsHow new technology can impact cardiac imaging in oncology clinical trials and have broader implications for patient safety.
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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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Collaboration PlanningSponsor-driven, CRO/recruitment provider collaborations propel cost-efficient study completion.
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Health Technology Assessment in Clinical Development: When to Bridge Research and Decision-MakingHealth technology assessment is a field of analysis that evaluates the medical, social, ethical, and economic implications of development, diffusion, and use of health technology.
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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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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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Driving Successful Clinical Trial Supply Management through Global Data CollaborationAn effective clinical trial is one of the most crucial stages in the creation of a new drug.
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Impact on the FutureThe use of RBM may be the only way forward as long as the development of medicines relies on clinical testing.
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Developing a Successful Peer-to-Peer Mentoring ProgramClinical research organizations should look to peer-to-peer mentoring for professional development.
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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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2020 Vision: Fulfilling the Future of Clinical ResearchIntroductionAfter decades of promise, we have begun to realize the fruit of “-omics” technology. Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels. Equally important, a growing suite of biomarkers now provides predictive value for diagnosis, disease progression and cure/remission.
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Getting to Clinical Trial DiversityDiffering levels of trust in clinical trials information channels across diverse populations is examined in this research.
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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.
