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Integrated Clinical Research Systems: A Chance to ReinventThe organization of healthcare is changing rapidly. The healthcare delivery system is increasingly powered by payers and regulators, and this directs both clinical medicine and drug development. Partly because of this change, the drug development process has been heavily scrutinized, and a great emphasis has been placed on more efficient translation of basic science into useful medicines.
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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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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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Eliminating ‘Disruption’ for Patients in Clinical TrialsExploring new ways to smooth the path toward better participation for patients and other research and healthcare stakeholders.
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Regulatory Approval in India: An Updated ReviewIssues concerning the drug approval process in India have occurred in clinical studies resulting in a reduced interest from sponsors. The Drug Controller General of India (DCGI) has been working to amend and update it’s policies to stimulate growth in this sector.
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Bring Your Own Device for Trial Outcome AssessmentSurvey uncovers the challenges, myths, and potential useful strategies associated with BYOD adoption.
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Syneos Health 2022 Health TrendsInsights from Syneos Health’s 2022 Health Trends: Insights for Industry Change Agent.
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Planning for Success in Late Phase Global Oncology TrialsFollowing four key study-design steps is crucial to the delivery of a successful cross-border cancer study
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Sweeping Aside the Hurdles of EMR and EDC IntegrationHistorically, some longstanding challenges have hindered efforts to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems.
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FDA’s Expedited Review Process: The Need for SpeedOutlining the requirements and benefits of FDA's four expedited drug approval pathways.
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FDA’s Expedited Review Process: The Need for SpeedOutlining the requirements and benefits of FDA's four expedited drug approval pathways.
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Global Biomarker and Companion Diagnostics Outsourcing MarketOver recent years global drug companies large or small have recognized that one root cause of the high failure rate in their clinical development lies in the selection of right therapeutic targets.
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Evaluating the Effects of Therapy MaskingUsing a specific trial, the importance of assessing the success of therapy masking is examined.
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Evaluating the Effects of Therapy MaskingUsing a specific trial, the importance of assessing the success of therapy masking is examined.
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Evaluating the Effects of Therapy MaskingUsing a specific trial, the importance of assessing the success of therapy masking is examined.
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Evaluating the Effects of Therapy MaskingUsing a specific trial, the importance of assessing the success of therapy masking is examined.
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Exploring the Role of the Regional CoordinatorHow one large academic trial adopted a coordinating center model-helping drive early-model RBM gains
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Where is the “Quality” in GCP?Over the years, clinical study management has become more fragmented. There are more organizations participating in a study, each bringing their own experiences, interpretations of requirements including how quality is defined. How is it possible that requirements and quality be interpreted so differently?
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Sentiment Analysis: Understand Your Healthcare CustomersSentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.
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Sentiment Analysis: Understand Your Healthcare CustomersSentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.
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Sentiment Analysis: Understand Your Healthcare CustomersSentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.
Latest:
Sentiment Analysis: Understand Your Healthcare CustomersSentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.
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Endpoint Adjudication of Events Charter Template: What Should Be Included?Endpoint adjudication is gaining importance in pharma today, however, no guidance on endpoint adjudication currently exists. The LinkedIn Endpoint Adjudication Community has generated an Events Charter Template to shed light on the subject for those in need of guidance.
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De-identifying Data in Clinical TrialsWhether we are referring to CSRs or to IPD, the personal information of trial participants needs to be de-identified prior to release. This article will describe the available methods for de-identifying clinical trial data, and the relative strengths and weaknesses of each.
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Bridging the Gaps in CAPA Planning in Clinical TrialsLeveraging approaches in RBQM to enable effective corrective and preventive action processes.
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Patient Safety Considerations for Follow-On Non-Biologic Complex DrugsBiologic drugs and non-biologic complex drugs have revolutionized the treatment of many difficult-to-treat diseases including cancer, multiple sclerosis, and chronic iron deficiency.
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Harnessing Patient-Centered Science to Improve Health Outcomes and Commercial Pharma SuccessGood scientific principles and practices are essential for maintaining quality data that patients can benefit from.
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Refined Safety AssessmentsA case study of how cardiac safety assessments can be enhanced with Holter Bin.
