Authors
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Linking Leaders: Beyond the BoardroomA view on redefining key roles across the evolving clinical development landscape.
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Is the New EU Clinical Trial Regulation 536/2014 Merely a Missed Opportunity?The EU has announced a new regulation - number 536/2014 - for clinical trials, which is planned to come into force not before 28th May 2016. It is an important step because it sets out the requirements for a single clinical trial approval portal and the content of clinical trial applications to be standardized.
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The Case for Universal GCP EducationThe primary objectives of GCP are to protect the safety, rights, and welfare of subjects, and to ensure the credibility of trial data and resulting reports.
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Shifting the Large Simple Trials ParadigmConducting Large Simple Trials to answer questions about "real-world" medical interventions is not a recent concept.
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Virtual CRA Meetings: Promoting Discussion, not SilenceVirtual CRA meetings hold a lot of potential, but work still needs to be done to ensure effectiveness.
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Trends in Clinical DevelopmentIndustry benefits from heightened innovation, site/sponsor relationships, and diversity.
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Enhancing Trial Enrollment Through 'Goal Programming'How iterative analysis of subject recruitment data can optimize outcomes during ongoing enrollment.
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The Twists and Turns in Biopharma Dealmaking: 2024 TrendsA deep dive into the complex playing field for M&A and partnering pursuits in today’s increasingly make-or-break landscape for biopharma innovation.
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Patient Engagement in PD Research and Why It MattersWhen we hear about a new blockbuster drug coming to market, we usually think about a medical treatment.
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Decline of Trials in CEE: Fluctuation or Trend?Examining why newly registered trials have fallen in Central and Eastern Europe, relative to other regions.
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TMF Reference Model Standard = Process EfficiencyOne of the many activities across the clinical development cycle that is non-negotiable is the creation, collection, management, and storage of the documents that are contained in the Trial Master File.
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Impact on the FutureThe use of RBM may be the only way forward as long as the development of medicines relies on clinical testing.
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Blood Pressure Evaluation During Early Phase TrialsA systematic approach for early identification of BP effects during development of new drugs.
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Getting to Clinical Trial DiversityDiffering levels of trust in clinical trials information channels across diverse populations is examined in this research.
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eSource Records in Clinical Research: Keeping it SimpleHow to satisfy regulatory concerns about EDC data integrity and site controls over its source records.
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The Case for Universal GCP EducationThe primary objectives of GCP are to protect the safety, rights, and welfare of subjects, and to ensure the credibility of trial data and resulting reports.
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Academic Medical Centers Can Tackle CTMS SuccessfullyThe excessive cost of clinical trials mixed with the inefficiency of clinical trial management is a widespread problem among research institutions.
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Shifting the Large Simple Trials ParadigmConducting Large Simple Trials to answer questions about "real-world" medical interventions is not a recent concept.
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An Ideal SOP SystemA "can’t live with them, can’t live without them" attitude is revealed in survey of standard operating procedures in the management and conduct of clinical trials.
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An Ideal SOP SystemA "can’t live with them, can’t live without them" attitude is revealed in survey of standard operating procedures in the management and conduct of clinical trials.
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Impact on the FutureThe use of RBM may be the only way forward as long as the development of medicines relies on clinical testing.
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Practical Thoughts on Common Standards: CDASH and E2B for Safety ReportingClinical research is complicated, and it?s not just the science. Take CDASH, CDISC and E2B for example. Aren?t acronyms awesome?
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The Importance of Detailed Patient Consent TrackingPatient consent is important to stay on top of for many reasons.
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CTMS: What You Should KnowThe dilemma facing clinical operations executives when selecting a CTMS solution to manage clinical trials is to go with an existing approach/solution or explore alternative options.
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SOPs in Clinical ResearchSurvey appraises the use of SOPs in clinical research from the sponsors' point of view.
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Re-Branding "Risk-Based Monitoring" - A Call for "Targeted Site Quality Management"With all of the buzz and excitement around risk-based monitoring, one might expect that the broad adoption of this emerging clinical research paradigm is well under way.
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Three-Pronged Approach to Optimizing Trial MonitoringStudy results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.
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Enhancing Trial Enrollment Through 'Goal Programming'How iterative analysis of subject recruitment data can optimize outcomes during ongoing enrollment.
