Authors
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Trials in Latin AmericaAn overview of the clinical research landscape in this emerging region that also looks at its challenges.
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Outsourcing to CROs: Expediting Clinical Operations or Oversight Nightmare?Simply handing off multi-million-dollar studies to CROs without carefully crafted plans for communications and reporting operational data as the study unfolds is hardly a wise move, yet what kind of oversight is needed? Live: Tuesday, Apr. 28, 2020 1pm EDT | 12pm CDT | 10am PDT On demand available after airing until Apr. 28, 2021. Register free
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A Ten Step Trial Crisis PlanToday's drug sponsors need to prepare and practice for worst-case clinical trial scenarios.
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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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Interactive Informed Consent: Better Informed Patients, Better TrialsIn July, at a meeting called by the U.S. Department of Health and Human Services on Human Research Protections, I reviewed the fascinating results of a randomized study that recently compared paper-based informed consent to electronic informed consent.
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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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Language & Culture in Global Clinical TrialsWith more clinical trials conducted overseas, sponsors are facing new obstacles.
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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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Late Phase Patient Reported OutcomesPatient-level feedback from later studies provides a multitude of valuable answers to all stakeholders.
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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.
