Authors
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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.
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Waive Inclusion and Exclusion Criteria?Waiving inclusion/exclusion criteria affects investigators, subjects, sponsors, and the trial itself.
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Regulatory Considerations for Digitally Driven TrialsTech companies entering space must adapt and adhere to regulations set by FDA.
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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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Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
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Paperless Clinical Trial Optimization—Thinking Outside the BoxThe implementation of best practices for clinical study and development conduct can streamline administrative burdens for investigator staff as well as study teams, and hopefully yield reduced costs in conducting global clinical development.
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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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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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The Face of Partnering in IndiaHow leveraging local expertise can make the migration east smoother for companies.
