Authors
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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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The Quality CoachThe right person can successfully promote proper management of quality and compliance, leading to desired clinical trial outcomes.
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Direct-to-Patient Enrollment StrategiesA comparison of the yields and costs of online outreach methods to other recruitment techniques.
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New Ways to Recruit Trial SubjectsTo minimize time to market, sponsors must explore new subject recruitment techniques.
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Medical Device TrialsUnderstanding the United States' regulatory pathways and clinical operations.
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Perspective and Hope From the ‘Other Side’Jim Kremidas, former executive director, Association of Clinical Research Professionals, shares his experiences as a patient in clinical trials.
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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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Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
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Medical Device ComplianceA probability sampling assessment by FDA takes a look at compliance in the medical device world.
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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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Early Labeling PaysEven before trials start, compiling a "target label" can add value by helping steer product development.
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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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A Canary in a Coal Mine?How the ability to apply text mining and signal detection algorithms to social media's real-time data provides unheard of value.
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Growth for Welsh CompaniesA rising initiative in Wales led by the International Business of Wales (IBW) promotes company growth in the region.
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Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
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Innovative Early Phase Trial DesignIncorporating original study design accelerates better development decisions.
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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.
