Authors
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Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.
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Leading Clinical ProjectsA survey of clinical research professionals asked: What makes you a successful project leader?
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Key Cost Drivers in Clinical Research: Guide to Successful BudgetingIt's almost impossible to map out study budgets with absolute precision. Planning for the unexpected costs, such as those associated with slow enrollment, protocol amendments, and other contingencies—is vital.
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The Revised Common Rule and New “Concise Summary” RequirementsLinda Reuter, CIP, Director of BRANY IRB, discusses the Revised Common Rule that now requires informed consent to begin with a concise and focused presentation of key information that will help the patient better understand the reasons why they might or might not want to participate in the research.
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Acquiring Medical Guidance in Clinical TrialsA critical part of clinical trial conduct is providing medical guidance by the responsible medical monitor to investigative sites and various operations team members, including, but not limited to, clinical research associates and clinical study managers.
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Five Strategies for Conducting Successful Pediatric TrialsSandra Pagnussat, of QPS, explores strategies to help combat the unique set of challenges that pediatric trials present.
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Biases in Characterization of Oncology Trials for Policy DecisionsChris Barker, an Independent Statistical Consultant, discusses the differences and biases in summaries obtained from a database called PDQ vs. CTG.
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Analytics and RBM for Clinical Trial OversightLearn the benefits of an approach that focuses on risks to the most critical data elements and processes of each study and how effective data integration is the foundation.
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Using AI & Machine Learning to Better Understand Data and Manage RiskBasheer Hawwash, Principal Data Scientist at Remarque Systems Inc., writes of the potential artificial intelligence, more specifically machine learning, has to transform clinical trials.
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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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eClinical Technology Considerations for Cell and Gene Therapy Studies: Case Study Snapshots of Personalized MedicineWith the world of gene therapy still rapidly evolving, an Interactive Response Technology system might help a sponsor navigate new and complex steps throughout the supply chain.
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eClinical Technology Considerations for Cell and Gene Therapy Studies: Case Study Snapshots of Personalized MedicineWith the world of gene therapy still rapidly evolving, an Interactive Response Technology system might help a sponsor navigate new and complex steps throughout the supply chain.
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Patient Experience Comes to Drug DevelopmentThe transformation in patient perceptions will only happen when the five million Americans who’ve already participated in clinical trials can directly share their experiences with the next five million people considering participating.
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Addressing a Critical Need for the Global Lupus CommunityGlobal experts collaborate to form the Addressing Lupus Pillars for Health Advancement (ALPHA) Project in order to combat challenges in lupus drug development.
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Pharma Companies Use AI to Advance Drug DevelopmentBioXcel Therapeutics Executives, Vimal Mehta and Vince O’Neill, discuss how they are actively using artificial intelligence to discover advanced therapies in CNS and oncology.
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Why Patient-centric Clinical Trials Are Easier Said Than DoneMichael Keens, COO of Firma Clinical, explores the beginning of patient centricity, common misconceptions related to its implementation, and offers steps to improve the ability to achieve patient centricity within drug development.
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A New Model to Support Leadership Skills of Principal InvestigatorsTaking a closer look at the skills expected from the Principal Investigator beyond the expected technical skills.
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A New Model to Support Leadership Skills of Principal InvestigatorsTaking a closer look at the skills expected from the Principal Investigator beyond the expected technical skills.
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A New Model to Support Leadership Skills of Principal InvestigatorsTaking a closer look at the skills expected from the Principal Investigator beyond the expected technical skills.
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The Changing Landscape for Advanced Prostate Cancer Treatment OptionsWith more than 174,000 new cases expected to be diagnosed this year, explore emerging areas and future challenges prostate cancer treatment is facing.
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Operational Complexity in Cell and Gene Therapy TrialsAs advanced therapy technology and manufacturing evolve, there are three key operational challenges to address unique to these products.
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Labeling Challenges from EU Annex VISimon Jones and Gordan Alexander, both of Prisym ID, explore the added complexity to the labeling of trial supplies that new regulations to EU 536/2014 will bring, specifically Annex VI.
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Labeling Challenges From EU Annex VIA new era for clinical trials supply compliance in the EU is almost here.
