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Cold Chain as a ServiceAccording to the IQVIA Institute for Human Data Science, the pharmaceutical industry loses roughly $35 billion annually as a result of temperature excursions, making transport one of the weakest links in many manufacturers’ supply chains.
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Multiple Expansion Cohort Clinical Trials: A Shorter Path to Success for Oncology DrugsThe rapid rise of targeted drugs and biologics in oncology has spurred sponsors and the FDA to innovate, leading to the creation of a variation to the typical trial design that can include multiple expansion cohorts.
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Want to Ensure Trial Success? Effective Management of Internal Team Calls may be a KeyIt is important to devote quality time to challenge yourself and your teams on whether there is a need to strategize and rethink the way you are conducting teleconferences for your clinical trials.
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The Ghost of Clinical Trials Past, Present, and FutureHave you seen many paradigm shifts lately?
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Data Dilemmas in Clinical Trials ContinueSurvey uncovers key findings amid today’s explosion of data volume and sources-and the added complexity in managing clinical data.
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Using Facebook Ads to Recruit Clinical Study ParticipantsFirst column in this series looks at the effectiveness of digital marketing as an outreach tool.
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Q&A: Capitalizing on Technology-Enabled Clinical ResearchIn the following Q&A, Guillaume Marquis-Gravel, MD, and Kevin Monroe discuss the advancements and related challenges of incorporating new technological tools in drug development, including eClinical approaches currently undertaken in the foundation’s own studies.
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Q&A: Capitalizing on Technology-Enabled Clinical ResearchIn the following Q&A, Guillaume Marquis-Gravel, MD, and Kevin Monroe discuss the advancements and related challenges of incorporating new technological tools in drug development, including eClinical approaches currently undertaken in the foundation’s own studies.
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How Tech and Data Enable Patient-Centric Clinical TrialsRemote trials have the potential to increase recruitment, reduce attrition, and make patients feel more engaged with the research.
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Non-Data Scientists: The Evolving Role of Clinical Data ManagementThe “citizen data scientist” is the person with no official data scientist training who uses the latest tools and technologies to handle data wrangling duties, analyze data, and create reports and models.
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Can Data from EHR Systems Be Trusted in a Trial Setting?An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.
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Can Data from EHR Systems Be Trusted in a Trial Setting?An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.
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Can Data from EHR Systems Be Trusted in a Trial Setting?An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.
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Can Data from EHR Systems Be Trusted in a Trial Setting?An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.
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Can Data from EHR Systems Be Trusted in a Trial Setting?An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.
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Breaking Down OHRP AssurancesThis article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).
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Breaking Down OHRP AssurancesThis article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).
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Breaking Down OHRP AssurancesThis article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).
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Breaking Down OHRP AssurancesThis article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).
Latest:
Breaking Down OHRP AssurancesThis article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).
Latest:
Breaking Down OHRP AssurancesThis article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).
Latest:
Breaking Down OHRP AssurancesThis article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).
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Optimizing Study Design in Real-World Evidence GenerationWith outcomes from “real life” a critical compliment to clinical trial data, the importance of involving an epidemiologist at study inception is explored.
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Weighing the Benefits of RBM ImplementationCase study demonstrates how one global mid-sized sponsor is testing the RBM waters.
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Analytics and Metrics Help Pinpoint Costs of Study Start-UpUsing data analytics to introduce parallel processes to optimize and accelerate clinical trials.
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Five Trends in Clinical Trials We’ll See in 2019Right now, we only seek “perfect patients” for our trials, rendering many drugs potentially less safe or effective for those in demographics the study was not designed for.
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Moving From Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research ProfessionalMedicines development and clinical research are among the most heavily regulated activities on a global basis.
