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What Google Can Teach Us About Trial Education, AwarenessSearch-engine data offers window to public consciousness around clinical trial research, participation.
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The Use of a Single Center, Multi-Location Research Structure For Participation in Large Clinical Trials: The Cleveland Clinic ModelAs funding for clinical research trials decreases and sponsors of clinical studies are under increasingly stringent timelines to obtain FDA approval and get new therapies to market, the need increases for well-managed, efficient, and effective clinical trial sites.
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Moving From Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research ProfessionalMedicines development and clinical research are among the most heavily regulated activities on a global basis.
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Clinical Trials and Social NetworkingThere are significant challenges facing the pharmaceutical and contract research organization (CRO) industries in relation to patient recruitment of clinical trials and the need to implement new strategies to finally overcome what has been called ‘the most difficult and challenging aspect of clinical trials.’
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Innovation in Ethical ReviewGoing paperless can help an IRB quickly collaborate, share documents, and review protocols.
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Steps for a Successful Clinical Trial Management SystemAs the importance of translational research continues to grow, research institutions are exploring other options to remain competitive players in the academic clinical research arena.
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Best Practices in IRT Implementation: A Checklist for Asia-PacPharmaceutical sponsors conducting clinical trials in the Asia Pacific region have a rare opportunity at hand...
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Common Technical Document DevelopmentPartnership formation is the new trend in common technical document development.
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Bridging the Disconnect in Pediatric Clinical Trial RecruitmentDespite the growing need for pediatric-approved medications, clinical trial enrollment for pediatrics remains challenging.
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5 Essential Cornerstones of RbM TechnologyOften overlooked in early evaluation of RBM are the tools and technologies required for successful implementation. Without the right tools to track and prioritize the shift from traditional monitoring to RBM, successful implementation is doubtful, posing detrimental consequences not only for the monitors, but also the overall trial.
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The Gene Therapy Product Development ProcessNavigating the many complexities in clinical trials, manufacturing, and regulatory interaction in moving gene therapies from development to market.
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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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Working in an Electronic World - How to Make a Smooth Transition to an eTMFIn the clinical development setting, most organizations are already working in an electronic world but still thinking in "paper."
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Centralized Statistical Monitoring As a Way to Improve the Quality of Clinical DataThe last decade has seen the complexity, size, and costs of clinical trials increase, which has made the task of guaranteeing data quality progressively difficult.
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Using Statistics to Improve Data Quality and Maximize Trial SuccessCentralized monitoring offers sponsors and CROs the program-wide oversight they need to successfully develop the medications of the future, says CluePoints CEO, Francois Torche.
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Assessing Drug Impaired (or Enhanced) DrivingExpect the FDA to be looking at a new metric in the drug approval process: driving safety.
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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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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.
