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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
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Personalized Medicine DevelopmentAs the popularity of personalized medicine grows the role of the CRO continues to evolve.
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Late Phase Study TrendsThis recent report explores key factors behind customer satisfaction and other dynamics within the Late Phase market.
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Pediatric Consent ErrorsThe intent of consent is that participants are comfortable with their choice and can comply with it.
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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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Archiving Approach in the UKThe proper storage of research documents remains an essential aspect of the clinical trials process.
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The Role of Observational Research & Patient Registries in Evidence GenerationThis whitepaper discusses the importance of observational research and patient registries in evidence generation. The modern healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes. These often conflicting perspectives require access to a portfolio of interventional and observational research designs sub-serving different objectives … Increasingly central is the inclusion of observational studies, including registries, which provide insights missing from traditional nterventional studies encountered in the course of drug development.
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A Structured Approach to Implementing a Risk-based Monitoring Model for Trial ConductAn effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
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A Structured Approach to Implementing a Risk-based Monitoring Model for Trial ConductAn effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
