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Data Protection Regime Change in the EU: The Impact on the Pharmaceutical IndustryAlthough the devil will be in the detail of the final compromise text of the General Data Protection Regulation (GDPR), we have highlighted below how a few of the proposed changes could potentially impact the pharmaceutical industry.
Latest:
Data Protection Regime Change in the EU: The Impact on the Pharmaceutical IndustryAlthough the devil will be in the detail of the final compromise text of the General Data Protection Regulation (GDPR), we have highlighted below how a few of the proposed changes could potentially impact the pharmaceutical industry.
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ICH GCP Goes Risk BasedIn this article, you will find a structured summary and critical review of the new addendum, and as well as ideas on how to prepare for these regulatory changes.
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A Centralized Monitoring Approach Using Excel for the Quality Management of Clinical TrialsPilot study evaluates the success of building quality into clinical trials using a plan-do-check-act (PDCA) approach to quality management.
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The Basics of Clinical Trial Centralized MonitoringExamining the practicality of implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs.
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Putting Our Shoulders to the Wheel: Thoughts on Data SharingData sharing in biomedical research has recently attracted widespread attention from physicians, scientists and stakeholders alike. DCRIs Dr. Eric Peterson discusses the context, flaws and positives of how this initiative could be implemented and the effects it can have on the industry.
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Interpretation of Regulatory Requirements by Technology Providers: The Case for Electronic Source DataThe authors contrast two views on the regulations concerning electronic source data.
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Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.
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Rare Diseases: Meeting the Unique Challenges of Orphan Drug DevelopmentPoor understanding of the natural history of the proposed indication due to few observational studies studying disease progression, heterogeneous patient populations with variable phenotypes and clinical courses, geographic dispersion of patients and investigators, regulatory uncertainties, and lack of prior clinical studies to establish a template for study execution, can all prove challenging in creating a pharmaceutical development program for the treatment of a rare disease.
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Africa a Ripe Proving Ground for Digital HealthA proposed operational framework to support digital- and mHealth-based clinical trials in Africa.
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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.
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Value-Based Planning & Drug Development ProductivityHow to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
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Value-Based Planning & Drug Development ProductivityHow to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
Latest:
Value-Based Planning & Drug Development ProductivityHow to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
Latest:
Value-Based Planning & Drug Development ProductivityHow to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
Latest:
Value-Based Planning & Drug Development ProductivityHow to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
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Stumbling Seven Times But Recovering EightJapan is increasingly a region where opportunities for global registration studies abound, supported by government policies as well as the medical community and its local population. However, incorporating Japan as an integral part of your global trial execution strategy does not come without its unique challenges.
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Could Gamification Improve Clinical Trials?Gamification is the application of game design principles and techniques to non-game contexts intending to create value for players and stakeholders alike. If applied, this principle can potentially drive greater innovation and efficiencies in clinical research.
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Engaging Physicians, Staff and Patients for Oncology TrialsAccruing patients depends greatly on engaged, enthusiastic PIs, as they are the gatekeepers in helping patients decide to participate in clinical trials. Building staff awareness and enthusiasm are also essential for retaining participants.
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How Will Technology Drive Global Clinical Trial Change by 2025?Exploring three pivotal technology areas that could reshape global studies over the next 10 years.
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Investigator Characteristics & Patient Recruitment in ALLHATAnalysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.
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Investigator Characteristics & Patient Recruitment in ALLHATAnalysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.
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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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Investigator Characteristics & Patient Recruitment in ALLHATAnalysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.
Latest:
Exploring the Role of the Regional CoordinatorHow one large academic trial adopted a coordinating center model-helping drive early-model RBM gains
Latest:
Investigator Characteristics & Patient Recruitment in ALLHATAnalysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.
Latest:
Exploring the Role of the Regional CoordinatorHow one large academic trial adopted a coordinating center model-helping drive early-model RBM gains
Latest:
Investigator Characteristics & Patient Recruitment in ALLHATAnalysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.
