Authors
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An Assessment of AdaptiveUnderstanding and using adaptive trial design to achieve the most of its available advantages.
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Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
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Mandatory Certification—It’s TimeIt is time for mandatory certification to be required for everyone involved in a clinical study.
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Simulation: A Critical Tool in AdaptiveHow simulation can help in the planning and implementation of adaptive clinical trials.
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EHR and EDC Integration in RealityAn evaluation of the Munich Pilot and the affects of the EHR-EDC integration solution.
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Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
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Survey Reveals Patient Recruitment is the Biggest Challenge in Pediatric TrialsA new study by Premier Research shows that both American and European pharmaceutical companies are facing similar problems in regards to pediatric trial regulations.
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Mastering Currency FluctuationStep-by-step process for budgeting global trials that uses a Currency Risk Management method.
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Reviewing FDA’s Latest Guidance on RWDRoadmap of twists and turns that lie ahead following most recent draft issued in September.
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Operation AdaptiveA concise look at this nontraditional approach to clinical studies that explains the how and why of it.
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Financial Simulation ModelingWith a PC and some software you can generate realistic projections that save time and money.
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Analysis: FDA’s COVID-19 Accelerated PathwaysLessons learned from FDA’s current process and proposed alternative review strategies.
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Integrated Drug SafetyCreating a drug's safety profile through the use of benefit-risk assessments during development.
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Trial Recruitment Without Trial and ErrorValidating protocols and identifying investigators with secondary data sources.
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Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
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EHR and EDC Integration in RealityAn evaluation of the Munich Pilot and the affects of the EHR-EDC integration solution.
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Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
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Patients as Partners in the API EraThe availability of FHIR-based APIs enabling patients to access and use their healthcare data for multiple purposes has opened a door to an entirely new world of opportunities for partnering with patients on clinical studies.
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Data Integration in the Age of Global TrialsThe difference a clinical trial management system can make in integrating a global workforce.
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Today's Global Site LandscapeNew survey from Tufts CSDD and Applied Clinical Trials provides an inside look at global sites.
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Investigator Site SurveyResults reveal insight into the roles, activities, pressures, and priorities of study coordinators.
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Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
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Is It Safe to Outsource Safety?Knowing when to outsource and when to conduct pharmacovigilance in-house is a crucial decision.
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Improving Site Efficiency and ProductivityReal-life examples of how a clinical trial management system impacted work-life for the better at five sites.
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Recruiting Diabetes SubjectsThe disconnect coordinating and connecting interested patients to clinical trials is an ongoing struggle.
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EHR and EDC Integration in RealityAn evaluation of the Munich Pilot and the affects of the EHR-EDC integration solution.
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Spotlight on Open-Label Extension StudiesOpen-label extension (OLE) studies are common, but they do not receive as much attention as traditional Phase I through Phase IV studies. Enrollment into an OLE study typically follows enrollment into a randomized, blinded, well-controlled main study. Participants are usually informed at the time they are recruited into the main study that they may elect to enroll in an OLE study after completing the main trial. The stated objective of most OLE studies is to obtain long-term safety and tolerability data.
