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Archiving Approach in the UKThe proper storage of research documents remains an essential aspect of the clinical trials process.
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Exploring the Role of the Regional CoordinatorHow one large academic trial adopted a coordinating center model-helping drive early-model RBM gains
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Exploring the Role of the Regional CoordinatorHow one large academic trial adopted a coordinating center model-helping drive early-model RBM gains
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Exploring the Role of the Regional CoordinatorHow one large academic trial adopted a coordinating center model-helping drive early-model RBM gains
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Exploring the Role of the Regional CoordinatorHow one large academic trial adopted a coordinating center model-helping drive early-model RBM gains
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The Evolution of CRAACO: Gains and Lessons LearnedTracking efforts to advance the mission and concept of "clinical research as a care option."
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Clinical Trials Status in BRICWith North America and Europe accounting for the majority of active clinical trial sites in 2016, the need for globalization is increasing. Brazil, Russia, India and China are emerging markets with potential, but not without challenges.
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Medical Device Body of Knowledge Training StrategyTo provide more targeted training and validate understanding to employees, it is important to establish baseline knowledge. This case study explores how Chiltern developed its Medical Device Body of Knowledge training program.
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Clinical Trial Design & Management: Best Practices for Small Budget StudiesClinCapture hosts a panel discussion with experts from CROs and sponsor companies to discuss conducting quality clinical trials in a cost effective manner.
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Drug Development through Modeling and Simulation - the Business CaseThe drug development process has been seen as inefficient and disappointing by those in the R&D space. Model and Simulation provides a potential relief to these issues by delivering significant business, scientific and clinical value to drug developers.
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Drug Development through Modeling and Simulation - the Business CaseThe drug development process has been seen as inefficient and disappointing by those in the R&D space. Model and Simulation provides a potential relief to these issues by delivering significant business, scientific and clinical value to drug developers.
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Be Part of the MovementDespite the increasing number of clinical trials in the United States, still participation remains at an all-time low. You can make a difference with participation in INC Research and CISCRP’s “Inspiring Hope’ Ideathon by submitting ideas to increase clinical research awareness.
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Accelerating Innovation Adoption to Support Drug Development OperationsCharacterizing the long-term adoption experience of clinical technologies and capabilities—and what senior leaders can do to drive adoption within their walls.
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Lean Outsourcing Models for Clinical Trials, Part 2: Optimizing TechnologyA key success factor for lean models is the possession of technology that can measure performance and manage risk in a well-organized and user-friendly manner. This article describes the results of an investigation to identify and describe the basic requirements for such technology solutions.
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New Benchmarks for Trial Initiation ActivitiesAssessing practices and inefficiencies with site selection, study start-up, and site activation.
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eConsent is Not What You ThinkHarmonization and value insights are fundamental to bring eConsent to the place it deserves.
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Patient Centric MS Trial ResultsA patient-centric approach to a Phase IV trial for an MS treatment resulted in lessons that can be applied to future therapeutic studies for this and other rare diseases.
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Patient Centric MS Trial ResultsA patient-centric approach to a Phase IV trial for an MS treatment resulted in lessons that can be applied to future therapeutic studies for this and other rare diseases.
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The Data-Decision Debate: To Share or Not to Share?Exploring the benefits from cross-company data sharing for study planning and investigator selection.
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Phase III Trial Failures: Costly, But PreventableAn examination of recent failures in Phase III studies and innovative approaches to reduce risk.
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Transformative Directions in Oncology Clinical TrialsOver the last decade, many initiatives sponsored by various entities, including academic and clinical research centers have focused on efforts to streamline clinical trial eligibility and data collection. Oncology trial design is no exception as endpoints and eligibility criteria have also changed with the value of the data generated in early phase studies.
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Simplifying eSignaturesWith the healthcare industry’s transition from paper to digital, verification is changing beyond that of a signature in ink. Electronic signatures are a new medium in clinical trials that the industry is now turning to in this transition to digital.
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Clinical Trials in Eosinophilic Esophagitis (EoE) - Advances and Opportunities with this Rare DiseaseEosinophilic esophagitis (EoE) is a rare esophageal condition that currently has no FDA-approved medications resulting in major gaps in treatment. Therefore, the need for better options and opportunities for drug development is apparent.
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Getting There: A Behind the Scenes Look at Cancer MoonShot 2020 - ACTThe Cancer Moonshot 2020 Initiative has been a long time coming for the team working to develop the program’s infrastructure and logistics. Following years of planning the result has been an increased response in the belief that a vaccine-based immunotherapy to battle cancer will be available by 2020.
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It’s Never Too Early for Cold Chain Planning for Cell TherapiesWith cell-based therapies possessing multistep supply chains and complex track and trace, logistics management systems can be useful for trials even in the protocol-planning stage.
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Monoclonal Antibodies: Clinical Pharmacology KeysOutlining the unique pharmacokinetic factors that should be considered when designing and running early stage clinical trials for monoclonal antibodies.
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Gastroparesis Treatment: What’s Coming Up NextGastroparesis patients face a series of symptoms for which there is currently a significant void in treatment. With complications and questions aplenty, answers are in high demand as physicians search for suitable medicines to combat this disease.
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The Observation Study ConundrumConducting observational studies is becoming a vital part of the clinical trial process, but research teams often struggle to operationalize these more creative and non-traditional study methodologies.
