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Benefits of a Combined eCOA/eConsent SolutionTechnology platforms are today continually being adapted into the clinical trial life cycle with the promise of efficiency and reduced risk. CRF Health believes its combined eCOA/eConsent solution could improve the flow of documentation between investigators and sponsors.
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GERD Treatment: Where We Went WrongPatients of gastroesophageal reflux disease (GERD) that have been frequently diagnosed, or misdiagnosed, have been dissatisfied with the available treatment. To resolve this issue, industry players must define meaningful endpoints for future trials, incorporate patient reported outcomes, and apply biomarkers.
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Interexpert Agreement on Adverse Events’ EvaluationStudy measures the differing judgment levels between clinical investigators and drug safety experts.
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Eyes Play a Focal Role in ResearchTwo unique techniques help characterize pharmacodynamic drug effects in healthy subjects.
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Smoother Regulatory Process for ChinaOne year ago, the China Food and Drug Administration (CDFA) was pushed to accelerate its activities to promote new or updated regulations and guidelines. Since then the results have been smoother processes for innovative drug development in China.
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Remote Monitoring of Patients in Clinical TrialsInvestment in mHealth and the adoption of wearables are significant initiatives that are changing the clinical trial process toward a more patient centered approach. These wearable technology initiatives have the potential to be the most innovative advances in drug development.
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Why CRCO is the Key to Increasing Patient-CentricityThe clinical trials space has shifted to a patient friendly, fast and easy process thanks to technological improvements, despite some gaps in the existing model. A Clinical Research Care Option (CRCO) can fill these gaps by fostering a more inclusive clinical research environment.
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UCLA Studies Participant PaymentA critical challenge that clinical trial researchers face is patient drop out. Why patients fail to complete studies can be attributed to a variety of reasons, and delays in compensation can often be one of them.
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Specialized Travel Services Can Help with Patient RetentionClinical trials endure high drop out rates due in part to long schedules, high travel costs and long reimbursement times. Outsourcing specialized clinical trial traveling services can help alleviate this concern by allowing sponsors to efficiently manage travel and other expenses.
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The Core of RBM is Centralized MonitoringThe use and awareness of risk-based monitoring is now impacting clinical trials of all sizes, indications and types as a core component more than ever before. Sponsors and sites are expected to expand its use to include all phases of clinical research and all therapeutics areas.
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Functional Dyspepsia: Can We Get the Trial Design Right?Functional dyspepsia is noted globally as being a common condition that currently has no specific therapy despite years of research. This condition is in need of an operational definition so that drug development and treatment trials can move forward with a more definitive trial design.
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Using Technology to Support NIH PolicyIndustry professionals are searching for new technologies to support their trials following approval of an NIH policy supporting single IRB practices. Transparent and auditable systems can offer stakeholders the ability to more effectively monitor and report regulatory responsibilities.
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What do Patients Want When Interacting with eDiaries? A 3-Part SeriesThis 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 3 covers how sponsors can humanize eCOA to help increase patient engagement during clinical trials.
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5 Reasons it’s Time for a Universal Standard of Knowledge in Clinical ResearchDue to mistakes by research professionals, clinical trials have been subject to delays or even cancellations. The National Board of Medical Examiners is working to reverse this trend by introducing an assessment to test the knowledge of clinical researchers.
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5 Reasons it’s Time for a Universal Standard of Knowledge in Clinical ResearchDue to mistakes by research professionals, clinical trials have been subject to delays or even cancellations. The National Board of Medical Examiners is working to reverse this trend by introducing an assessment to test the knowledge of clinical researchers.
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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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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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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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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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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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Top Three Translation Strategies for Global TrialsGlobalization has increasingly become a part of the clinical trial landscape as pharma sponsors conduct trials internationally. With language barriers being among the challenges of this process, translation management is now a must during the planning phase of a global trial.
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What Are You Wearing?While wearable devices are mainly an advantageous way to collect data from monitoring a trial participant’s progress, there are scientific and operational considerations to be aware of.
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The Growth of Direct-to-Patient TrialsQ&A explores the evolution of community-based studies-and the related sample management, regulatory, compliance, and logistics support considerations.
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Direct-to-Patient Clinical Trials: Strategies for SuccessThe exponential growth in the use of Direct-to-Patient clinical trials and the strategies pharmaceutical manufacturers should consider when implementing this model.
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Assessing Global Clinical Supply LogisticsStudy collects first comprehensive metrics on current supply management and distribution practices.
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Assessing Global Clinical Supply LogisticsStudy collects first comprehensive metrics on current supply management and distribution practices.
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Assessing Global Clinical Supply LogisticsStudy collects first comprehensive metrics on current supply management and distribution practices.
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Ensuring High-Quality Data in Complex, In-Home Clinical TrialsTo support complex in-home clinical research and investigative sites, well-designed trials must produce the same high-quality data as traditional sites.
