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The Challenge and Opportunity Presented by Clinical Trial Regulation EU 536/2014New regulations offer opportunity for simplification in strategic planning.
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Best Practices in Study FeasibilitySurvey drills down on the preferred methods of sponsors, CROs, and sites in conducting feasibility analysis.
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The Evolution of Imaging Techniques in Clinical TrialsEvaluating the use of new tumor measurement tools for studies of molecular-targeted cancer therapies.
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A New Regulatory Road in Clinical Trials: Digital TwinsThe promise and acceptance of using this AI tool in drug development is growing.
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Proscia Launches Commercial Research Edition of Digital Pathology PlatformChief Product Officer for Proscia, Nathan Buchbinder, discusses Proscia’s Concentriq and its benefits for CROs and life science organziations.
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Maximizing Recruitment of Targeted Oncology PopulationsWhile some countries are more progressive in approaching this challenge by virtue of mandatory, free of charge, molecular testing on all patients, this varies greatly in other countries based on institutional policy and insurance reimbursement.
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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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Clinical Trial Data StewardshipAmid the push for clinical trials to adopt more modern digital data technologies, the job of assuring adherence to key data quality and integrity principles is achievable under current regulations governing electronic record-keeping. Doing so, however, will require a new and reinvented framework: data stewardship.
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The Transformation of Clinical Trials from Writing on Papyrus to the World of TechnologyNew requirements must be put in place to ensure data quality and integrity.
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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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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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Specialized Safety Needs for Small and Midsize CompaniesMeeting today’s complex regulatory demands when it comes to drug safety and pharmacovigilance can be especially challenging for small and medium-sized organizations. This report presents the benefits for these companies in outsourcing such activities to functional service providers (FSPs) during clinical trials and post-approval.
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The Limited Impact of COVID-19 on US Clinical Trial ActivityResearch shows there was no decline in non-COVID related study spending during height of pandemic.
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Endpoints in Cancer Trials: Putting Patients FirstIn the debate over patient-centric considerations in cancer care, one main focus has been the choice of proper endpoints for clinical trials.
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Optimal COA Measurement Strategy in Modern Oncology TrialsExamining the two areas of weakness cited in FDA draft guidance.
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The DCT Network: When Experienced Providers Come Together, We Can Revolutionize Clinical ResearchPatients reap benefits of strong collaboration in executing DCTs.
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Genomes, Big Data and the Journey to Precision MedicineThis month marks a landmark in the quest for personalized medicine and the growing role of big data in health sciences – from clinical development through tracking patient outcomes long after a therapy has reached the market.
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Wearables: Where is Clinical Development Headed Next?The application of personal device technology in the health care space continues to evolve, fed by the development of health-related consumer products and services by segments of industry traditionally not focused on health
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Closing the Variance Gap: The Challenges with Clinical Trial Budget Management and ForecastingAs clinical trials continue to grow in complexity, tolerance for the growing variance between forecasted and actual clinical trial costs is shrinking.
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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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Safety Considerations for Follow-On Non-Biologic Complex DrugsWith patents for many NBCDs soon to expire, the need for regulatory guidance regarding follow-on versions of these products is crucial.
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Clinical Trial Recruitment in the Digital Era: Some Smart IdeasChallenging. Time-consuming. Expensive. Do words like these spring to mind when you contemplate the patient recruitment process for your clinical trials?
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Optimizing Clinical Trials Using Electronic Measurement and Analysis of Drug AdherenceDrug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority
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Machine Learning, Modeling, and Predictive Analytics: Key Principles for the Clinical ScientistWith the inherent limitations of traditional data sources, this overview explores the definitions and strategic fundamentals that inform machine learning and modeling techniques.
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Is There a Link Between Recruitment and Social Media?A survey of Belgian clinical research professionals offers insights into the future of social media
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Is There a Link Between Recruitment and Social Media?A survey of Belgian clinical research professionals offers insights into the future of social media
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The African Medicines Agency: Impacts on the Continent’s Clinical Trials RegulationHarmonization could turn the continent into an established site for clinical research and laboratories.
