Authors
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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.
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Effective BioPharma R&D Outsourcing PartnershipsAs biopharmaceutical companies form partnerships with vendors for R&D, they can learn important lessons about outsourcing from the vastly different experiences of Toyota, Honda and their American counterparts.
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How Do Regulatory Intelligence and Operations Envision Technology?The shift from paper to cloud-based regulatory information management systems (RIMS) to address operations challenges.
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Navigating Robotic Process Automation, ICH E6(R3) Changes, and Outsourcing in Clinical TrialsSix trends to help guide trial master file strategy.
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How Organizations Can Put Sites First When Implementing New Trial TechnologyOrganizations that continue to disregard the technological needs of one of the industry’s core audiences run the risk of having their trials ignored.
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Industry Report on Outsourcing Spend, Models, and MeasuresA look at the findings from Avoca Group’s 2018 industry research survey on clinical outsourcing.
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Initial Design Considerations of Trials of Immuno-Oncology: Domains and ElementsIMPs for immunotherapeutics require a different mindset, effective strategies, and meticulous planning, among other things, says KCR Trial Execution and Consulting.
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The Future of Clinical Monitoring: How RBM, RBQM, Centralized and Remote Monitoring are changing the monitoring paradigmIf you are responsible for delivering clinical or decentralized trials as a project lead, heading up clinical operations, medical or clinical monitoring, or driving your outsourcing strategy, attend this webinar to better understand the breadth of your choices. Monday, September 27, 2021 at 11am EDT
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China: A New Era of Drug Development and InnovationAs China’s pharma industry continues to evolve and mature, it is hoped overseas expansion and greater innovation will be exported to serve the interests of patients.
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Establishing Early Phase Capabilities in MalaysiaExploring the nation’s opportunities for growth and the initiatives undertaken to build an attractive clinical trials ecosystem for early stage research.
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Establishing Early Phase Capabilities in MalaysiaExploring the nation’s opportunities for growth and the initiatives undertaken to build an attractive clinical trials ecosystem for early stage research.
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Opportunities for Improving Clinical Decisions with Patient Centric Remote Blood Sampling ApproachesThis article sets out a vision of adopting convenient alternative blood sampling approaches that places the needs of the patient at the center and enables active monitoring, before the onset of clinical events, leading to improved healthcare.
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DIY Blood Sampling for Pediatric Clinical Trials—The Patients PerspectiveA recent survey shows that 40% of pediatric trials conducted between 2008 and 2011 were never finished or published. One of the main challenges is the need to collect multiple sequential blood samples. Which, mircosampling, could be the answer to.
