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The PUEKS Project: Process Innovation in Clinical Trial MonitoringA look at the results of the recently completed project, which aimed to develop an holistic monitoring system via process integration to more effectively control clinical trial risks beyond isolated RBM strategies.
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The PUEKS Project: Process Innovation in Clinical Trial MonitoringA look at the results of the recently completed project, which aimed to develop an holistic monitoring system via process integration to more effectively control clinical trial risks beyond isolated RBM strategies.
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Unlocking the Potential of eClinical TechnologiesKey considerations for successful implementation in decentralized clinical trials.
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Improving Clinical Trial Delivery Times: Best PracticesFinalizing protocols, aligning teams, and staying engaged headline best practices.
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Clinical Trial TechnologyAlmac provides an overview of their clinical technologies branch, their IRT offerings, and the current changes to the clinical development industry.
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Rebadging Gains Momentum Amidst COVIDCapacity management and stability offer value for clients, their employees and FSP vendors.
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Rebadging Gains Momentum Amidst COVIDCapacity management and stability offer value for clients, their employees and FSP vendors.
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Functional Service Partnerships: A Case Study for CRO Resource ManagementA review of a recent FSP in which the CRO partner assumed clinical monitoring and site support responsibility for more than 50 ongoing trials.
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Making a Difference in Cancer Trials AccrualThe integration of pre-screening all patients for eligibility in oncology studies.
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Adoption of RBQM in Academic Settings: Lessons LearnedThis article discusses the adoption of RBQM in academic settings and the lessons that were learned.
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Pharmaceutical Leaders Call for the Use of GS1 Standards in Clinical ResearchThe GS1 Standards will enable more efficient processes at institutions that are already using an electronic inventory system to manage investigational products.
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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.
Latest:
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.
