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The Enrollment Rescue Dilemma: How Sponsors and Sites Can Make the Most of a Tough SituationSurvey uncovers key best practices that sponsors, CROs, and sites should consider when faced with patient enrollment challenges.
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The Time is Now to Promote Clinical Trial Workforce DiversityThe pandemic has thus far disproportionally impacted minority populations, and our ongoing failure to adequately represent all patients regardless of demographic background has never been more important to remedy than it is today, writes ACRP Workforce Innovation Officer Beth Harper.
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Regulatory Changes Position China as a Global Clinical Trial DestinationGeorge Clinical's Managing Director discusses the concern biopharma companies have with CFDA's slow drug and medical device approvals.
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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.
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Supporting Marketing Authorization Applications with Non-Clinical OverviewsWith the ever changing regulatory landscape, outsourcing non-core activities is a flexible approach to managing resources and remaining compliant with NCO requirements for the entire generic portfolio.
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Sponsors—Can You Answer 6 Questions Regulators ask During Audits?During an audit, the FDA investigates six areas to determine whether a site is in compliance with federal drug accountability regulations-can sponsors answer them?
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Get Ready for mHealth to Revolutionize the Device MarketMobile health devices are poised to transform medical care-and with it the medical device market.
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Big Changes for EU Medical and In Vitro Diagnostic Device RegulationsThe EU is launching a major transition within their legislation for medical and in vitro diagnostic devices. This transition is important and should include assessing the financial viability of the pipeline, expanding data collection, and locking in soon-to-be-scarce notified body resources.
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In-Home Trial Supply ChallengesCRO's and sponsors are taking clinical trials to homes. These in-home trials can address participation issues and provide added convenience plus support for patients, but they also come with their own set of risks.
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Single IRB Review for All Multicenter Clinical TrialsSince the emergence of the independent IRB sector, sponsors have found that regulatory and ethical review by a single IRB yields important benefits with respect to efficiency, high quality, and consistency in human research protections.
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Single IRB Review for All Multicenter Clinical TrialsSince the emergence of the independent IRB sector, sponsors have found that regulatory and ethical review by a single IRB yields important benefits with respect to efficiency, high quality, and consistency in human research protections.
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Acquiring Medical Guidance in Clinical TrialsA critical part of clinical trial conduct is providing medical guidance by the responsible medical monitor to investigative sites and various operations team members, including, but not limited to, clinical research associates and clinical study managers.
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Tissue IHC: Translating Technology into Patient Testing After Biomarker Target is IDIn the discovery and investigation of novel biomarkers, tissue immunohistochemistry (IHC) studies are critical, but how do you translate the technology into the clinical laboratory for patient testing once a biomarker target has been identified?
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Clinical Trials in Kazakhstan: Open For BusinessThis brief overview of Kazakhstan presented by Vlad Bogin will help you get acquainted with this emerging clinical trial location.
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Cancer Immunotherapy Biomarkers: Four Trends to WatchHere are four trends to watch as researchers continue to make headway in the development of biomarkers for cancer immunotherapy.
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Overcoming Complexities of Clinical Trial Supplies in Latin AmericaSupply chain strategies require a close look at the regulatory factors and the drug import hurdles and hopes in the region.
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Overcoming Complexities of Clinical Trial Supplies in Latin AmericaSupply chain strategies require a close look at the regulatory factors and the drug import hurdles and hopes in the region.
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Monitoring Temperature Control Throughout IMP Supply JourneyHow a single-source temperature management strategy can support a drug’s quality and integrity in transit-a process as important as the destination.
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The Impetus for Natural History Studies in Rare Disease R&DThe use of natural history (NH) studies early in clinical research can help facilitate development programs for orphan drugs.
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The Impetus for Natural History Studies in Rare Disease R&DThe use of natural history (NH) studies early in clinical research can help facilitate development programs for orphan drugs.
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New Role To Improve Clinical Trial PerformanceWith several systems existing to measure performance, the most significant are the course of patient recruitment, how many patients complete the study, as well as the quality of the data generated.
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Four Pillars to Achieve Patient CentricityZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.
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How Pharma Can Work with the FDA to Embrace Innovation and Overcome Its “Adoptaphobia”FDA commissioner Scott Gottlieb criticized pharmaceutical companies and clinical research organizations for being slow to adapt innovations in clinical research, claiming that the business model adopted just isn’t compatible with the kind of changes that certain innovations can enable.
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Four Pillars to Achieve Patient CentricityZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.
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Four Pillars to Achieve Patient CentricityZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.
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RBM—An Update of Experiences Among European CRAsAn RBM survey conducted in 2014 was repeated in 2016 in order to find out, how knowledge and practical experience with RBM have changed over that time period.
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RBM—An Update of Experiences Among European CRAsAn RBM survey conducted in 2014 was repeated in 2016 in order to find out, how knowledge and practical experience with RBM have changed over that time period.
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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.
