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Generic Drug Repurposing Clinical TrialsGeneric drug repurposing can often create medical solutions regardless of the supporting entity. “Unsolved” diseases can benefit from this strategy despite commercialization challenges.
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Closing the LoopPatient recruitment remains a challenge for both the biopharma industry and the oncology research community. New recruiting platforms in development have the potential to change the way the industry uses technology, data and the internet to augment recruiting efforts.
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Multidisciplinary Approach to Protocol WritingThis article examines the requirements for developing an effective Clinical Trial Protocol, observing that it takes time, commitment, and a full team effort to produce protocols of an acceptable standard.
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Remote Monitoring of Patients in Clinical TrialsInvestment in mHealth and the adoption of wearables are significant initiatives that are changing the clinical trial process toward a more patient centered approach. These wearable technology initiatives have the potential to be the most innovative advances in drug development.
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Bring Your Own Device for Trial Outcome AssessmentSurvey uncovers the challenges, myths, and potential useful strategies associated with BYOD adoption.
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Patient Engagement Surveys in Clinical Trials: Dos, Don’ts and How They HelpThis article will address concerns and look at how the pragmatic implementation of surveys in today’s clinical trials can provide valuable insight into patient satisfaction levels, motivators, likelihood to follow study requirements and information retention.
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Taking eCOA Delivery Off the Critical Path to First Patient InStreamlining electronic clinical outcome assessment and patient-reported outcome processes can aid in decreasing timelines.
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Where’s the Exit? An Update on BrexitWith the U.K. poised to begin the process of leaving the European Union soon, many questions remain as to the specifics of pharma regulation and the wide-ranging effects of this departure.
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How Do iComply? Regulatory Topics Surrounding mHealth in Clinical TrialsOutlining several critical areas of regulatory oversight that clinical trial researchers need to consider when using mHealth technologies.
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Digital Transformation of SAE Data Capture in Clinical StudiesProcesses for collecting data of serious adverse events (SAEs) and events of special interest (ESI) during clinical trials have been underwhelming for sponsors. Improving these processes using the latest digital advances can result in more complete analyses and more effective decision-making.
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Future Directions of Cancer Immunotherapy in Clinical TrialsProgress and innovation within oncology has accelerated to a paradigm that includes immunotherapy and bio-genomics. Collaborative approaches in the future will continue to transform treatments in hopes of improving patient quality of life.
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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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Partnering with Patients: Clinical Trial Retention and Engagement through Patient Data ReturnHow sharing patient data drives trial engagement and honors patient contributions to the research process.
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The FDA's Guidance on PROThis guidance has both raised the stakes and improved the odds of securing label claims based on PROs.
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Early Phase Pharmacodynamic Models for Respiratory Drug CandidatesRespiratory disease trials are difficult to initiate, both in terms of patient recruitment and accurately collecting data. Alternative methods are required to improve outcomes and develop new treatments for respiratory diseases.
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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.
