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Can Sponsors Answer 6 Questions Regulators Ask During Audits?Switching from paper records to an electronic drug accountability IRT system can benefit sites during FDA trial site audits.
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Patient Value Creation & Pharmaceutical R&D PrioritizationJames Man considers the practical measures firms can take to embed the patient perspective more directly into their R&D planning.
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What ICH E6 (R2) Means for Investigative Sites, Risk Assessment and Clinical Trial MonitoringThe last time the ICH GCP Guideline was updated, the process of conducting a clinical trial, including risk assessment and monitoring, was a largely paper-based affair. Since then clinical trials have evolved substantially as they’ve become more complex, costly, and global in scope.
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What ICH E6 (R2) Means for Investigative Sites, Risk Assessment and Clinical Trial MonitoringThe last time the ICH GCP Guideline was updated, the process of conducting a clinical trial, including risk assessment and monitoring, was a largely paper-based affair. Since then clinical trials have evolved substantially as they’ve become more complex, costly, and global in scope.
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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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Just Buzzwords or Can Innovative Technologies Truly Transform Clinical Trials?Looking beyond the hype to see how innovations such as data, techniques, and technology can be brought together to improve the lives of patients.
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How to Detect, Manage, and Report Fraud and Fabricated Clinical Research DataThis article will examine the ways to detect fraud and data fabrication within a clinical trial.
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To Sign or Not to Sign FDA Form 1572?Exploring that pivotal question for clinical investigators, sponsors, and global CROs.
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Prioritizing the Patient VoiceAMPLEXOR’s Dana Weiss explains the critical role of linguistic validation in enabling the patients voice.
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How to Manage Machine Learning Algorithms in Clinical TrialsMachine learning algorithms can be used to both manage the complex outputs in clinical trials and make those trials move faster with less risk, reducing timelines, and minimizing expenses.
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Global Risk Based Monitoring: An Invite from Oxford and Duke ResearchCBI, the conference group sister of Applied Clinical Trials, is featuring their Global Risk Based Monitoring Conference in September.
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Global Risk Based Monitoring: An Invite from Oxford and Duke ResearchCBI, the conference group sister of Applied Clinical Trials, is featuring their Global Risk Based Monitoring Conference in September.
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Key Strategies CRA’s Use to Maintain Good Clinical PracticesMichael Sydes outlines some strategies that CRA's can use to maintain good clinical practices.
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The Importance of Age Diversity in Clinical TrialsAge diversity in clinical trials benefits both the patient experience and the success of the trial.
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Patient Engagement Surveys in Clinical Trials: Dos, Don’ts and How They HelpThis article will address concerns and look at how the pragmatic implementation of surveys in today’s clinical trials can provide valuable insight into patient satisfaction levels, motivators, likelihood to follow study requirements and information retention.
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How to Avoid Common Pitfalls of Market LandscapingKey tips and resources to help evade the common traps of market landscaping-today an increasingly high-stakes and comprehensive task during clinical development.
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New ICH Guidelines Address Industry InefficiencyIn this article, Crissy MacDonald reviews the key changes in ICH E6 (R2), discuss the challenges organizations are facing, and present actionable recommendations for organizations to implement now.
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Using Feasibility Tools to Build Better Sponsor–Investigator RelationshipsFeasibility, the evaluation of whether a particular trial can recruit enough of the right patients so that the study completes on time and within budget, is arguably the most critical part of the clinical trial process.
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Recent Trends in Clinical Trials for Coronary DiseasesIn this study, Clinical Trials Transformation Initiative’s database for aggregate analysis of ClinicalTrials.gov was used to evaluate the number of ongoing and completed interventional clinical trials for various coronary diseases.
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Navigating the Complexities of Drug-Biomarker Co-DevelopmentSuccess in developing targeted medicines means companies need a companion diagnostic strategy, the expertise, and more.
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Clinical Trials In a Dish: A Revolution BeginsThe emergence of CTiD offers the potential to remove future clinical failures much earlier in the process-and pave way for gains in R&D productivity.
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Clinical Trials In a Dish: A Revolution BeginsThe emergence of CTiD offers the potential to remove future clinical failures much earlier in the process-and pave way for gains in R&D productivity.
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Clinical Trials In a Dish: A Revolution BeginsThe emergence of CTiD offers the potential to remove future clinical failures much earlier in the process-and pave way for gains in R&D productivity.
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Challenging the ‘Site-first’ Status Quo in Patient EnrollmentCase study highlights a new patient-centric enrollment model that uses a data-driven approach to identify qualified patients first.
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Challenging the ‘Site-first’ Status Quo in Patient EnrollmentCase study highlights a new patient-centric enrollment model that uses a data-driven approach to identify qualified patients first.
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The Future of Mobility and MedicineThe role of the cloud in realizing the practical benefits of mHealth in clinical trials.
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The Status of Ebola VaccinesMarket players working on development of vaccines to fight against the virus are focused on clinical trials and look forward to gaining approval from regulatory bodies.
