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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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Imaging CROs in AsiaImprovements in image acquisition and read quality: A look at the value of standardization in oncology trials.
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Value of Time and MoneyIndustry Standard Research has recently released its 3rd annual "CRO Quality Benchmarking Report." The report not only profiles the delivery quality of leading CROs, but also provides a wealth of information that relates to larger industry trends, including the value of recruitment speed.
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Long-term Electrocardiographic Monitoring: Time to Rethink What We Know?With significant technology advances in ECG recording through the years, the need to expand on traditional monitoring baselines-and include new variables such as time when designing clinical trial protocols-is important.
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Current Challenges of Poor R&DTransfer of material between the supply cahins can be time consuming and complicated
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Clusters' Last Stand?While order might be useful for smaller firms to do business, it is not useful in helping them to innovate.
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Sponsor-Investigator Relationships: A Crisis of Trust in Life SciencesTimely completion of clinical trials is the weak link in the drug development process, and there is no shortage of suggestions for how to improve it.
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Major Changes to Clinical Trials Regulation in the EUThe new Clinical Trials Regulation introduces an overhaul of the existing regulation of clinical trials for medicinal products in the EU.
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Switzerland Guides Innovation in Clinical Trial RegulationsThe country’s introduction of a new legal framework has it in sync with European law on clinical research.
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Strategic Approach Needed for International Clinical TrialsLonger-term strategic issues are making already high-investment, high-risk decisions to place studies overseas even more complex.
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A PK Mystery SolvedHow modeling and simulation clarified complex exposure levels and an orphan drug got approved.
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A PK Mystery SolvedHow modeling and simulation clarified complex exposure levels and an orphan drug got approved.
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Strategic Approach Needed for International Clinical TrialsLonger-term strategic issues are making already high-investment, high-risk decisions to place studies overseas even more complex.
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Exposing Patients to the Bigger Mobile and Digital Health PictureThe World Health Report 2013 argues that universal health coverage cannot be achieved without the evidence from scientific research, and in order to better manage healthcare, clinical research needs to keep up-to-date and advance in line with society in general.
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Turning Signals Into Action: A New Model for Risk-Based MonitoringA new solution will seamlessly and electronically exchange data from the RBM system to the EDC platform, and vice versa.
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Four Ways to Improve Pharmacovigilance Processes with AutomationBio-pharmaceutical companies are continually tasked with gathering more safety information and responding to requirements more quickly. Recent examples of significant changes in reporting requirements include 2010/84/EU and Regulation Number 1235/2010 on pharmacovigilance, and the 2012 European Medicines Agency (EMA) new guidelines on good pharmacovigilance practices.
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Efficient Pre-implementation of Multi-site Clinical TrialsMethod designed to reduce the time gap between protocol approval and recruitment is examined.
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Configuration or Customization: Is the Software Solutions Debate Already Over?Inevitably, the conversation consistently comes back to a simple philosophical debate?should software solutions be configurable or customizable?
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Value-Based Auditing of Clinical Trial Software SuppliersWhy do we audit our suppliers and what do we hope to achieve when we do?
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Outsourcing Model Usage and its Relationship to Clinical Trial PerformancePilot study seeks to validate new and more granular outsourcing model classifications in differentiating performance across custom contract-service approaches.
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Learning from Failure, Leveraging Biosimulation for Pediatric Drug Development SuccessPediatric trials now feature increased modeling and analytics for safer drug dosing and response.
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Leveraging a Unified Data Model to Drive Collaboration and Clinical Trial EfficiencyThis article will focus on a case study example of a collaborative effort to share investigator, site, and study information across companies, and on the single data model that underpins it.
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The Remote Patient-Centered Approach in Clinical ResearchIn the healthcare arena, the concept of patient-centeredness has expanded over the last 50 years, beginning as a term to describe patient engagement in self-health management and evolving to include various aspects of patient engagement in healthcare research.1
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Risking it All? Going All in on RBM AdoptionCancer Research UK (CRUK) followed such advice when it decided to have its Center for Drug Development (CDD) adopt a risk-based monitoring (RBM) approach across its entire portfolio of clinical trials.
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Placebo Effect of Transdermal NSAIDSThe implications and challenges of the placebo effect on regulatory agency product approval.
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Manage Trial Master Files via Investigative PortalsAutomated eTMF solutions reduce costs, improve productivity, and enhance data management.
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Demystifying Asian TrialsConducting clinical research in the East brings a new group of challenges to sponsors
