Authors
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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.
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Technology’s Role in Clinical TrialsHow the use of eSource, eTMF, and other cloud-based solutions are changing clinical trials
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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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Recruiting Strategies for Clinical TrialsSix years ago, our department of a large academic research center was having difficulty enrolling enough subjects in osteoporosis studies. We wanted to expand into a variety of trials and increase the number of participants. Despite our experience and expertise, our enrollments were down. We wondered if the pool of eligible participants was shrinking, if our competition was doing a better job than we were, or if we needed to modify our project management style.
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Perspectives and Guidance for Effective eCOA in Global DCTsGuidance on the unique challenges presented by electronic outcomes.
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Three Reasons to Integrate a CTMS and EMRIntegrating a CTMS and an EMR can provide many benefits for supporting the health care needs of patients.
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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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RBM in Late PhaseThe reality of risk-based monitoring: history and successful implementation for late phase research.
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Developing a Successful Peer-to-Peer Mentoring ProgramClinical research organizations should look to peer-to-peer mentoring for professional development.
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Decline of Clinical Trials in Central and Eastern Europe: Fluctuation or Trend?In some countries, the participation in clinical trial, is still the only possibility to be treated.
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Developing a Successful Peer-to-Peer Mentoring ProgramClinical research organizations should look to peer-to-peer mentoring for professional development.
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The Benefits of Advanced Imaging Management SystemsHow new technology can impact cardiac imaging in oncology clinical trials and have broader implications for patient safety.
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RBM in Late PhaseThe reality of risk-based monitoring: history and successful implementation for late phase research.
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Collaboration PlanningSponsor-driven, CRO/recruitment provider collaborations propel cost-efficient study completion.
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Health Technology Assessment in Clinical Development: When to Bridge Research and Decision-MakingHealth technology assessment is a field of analysis that evaluates the medical, social, ethical, and economic implications of development, diffusion, and use of health technology.
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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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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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Driving Successful Clinical Trial Supply Management through Global Data CollaborationAn effective clinical trial is one of the most crucial stages in the creation of a new drug.
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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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Developing a Successful Peer-to-Peer Mentoring ProgramClinical research organizations should look to peer-to-peer mentoring for professional development.
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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.
