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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.
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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.
Latest:
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.
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The Biotech Reset: Navigating the Path ForwardWebinar Date/Time: Thursday, May 2nd, 2024 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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The Critical Importance of Real-Time Access to Clinical Study PerformanceThe need to see real-time study performance is vital, as teams focus on meeting timelines and ensuring resources are appropriately allocated, writes EVP of WCG, Jonathan Zung.
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Alzheimer’s Research Finds New BeginningsDespite mounting frustrations in drug R&D for Alzheimer's disease, emerging biopharma firms are still pursuing AD therapies with new science, and different preclinical and clinical trial models.
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The Challenges in Fulfilling the Promise of Precision OncologyOutlining the three critical challenges that need to be addressed to make personalized cancer treatment a reality.
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Delivering on the Promise of Precision Medicine: The Critical Role of Specialty LabsDarren Davis, Senior Vice President at Precision for Medicine, explores the need for specialty labs in cancer treatment plans.
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Clinical Supply–Why Putting Patients First MattersThe time to stop hammering square pegs into round holes in terms of design strategy has come, as sponsors embrace an adaptive supply chain approach.
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Digitalization Trends in Tackling the Complexity of Clinical Trials for Patients with Multiple Health ConditionsDigitalization has been progressively facilitating increased access to trials by helping alleviate logistical burdens, but not much is known about how these tools can address the needs of patients with multiple chronic conditions.
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Dementia Doesn’t Discriminate—Neither Should Dementia ResearchCherry-picking a small group here and a dementia risk factor there won't reflect the way that dementia affects people from every walk of life, writes CEO & Founder of Savonix, Mylea Charvat.
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Building A Better FSPOutlining the three concerns communicated the most when it comes to implementing an FSP outsourcing strategy.
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Building A Better FSPOutlining the three concerns communicated the most when it comes to implementing an FSP outsourcing strategy.
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Operationalizing Complex Clinical TrialsInsights from a roundtable at Halloran’s Clinical Operations Retreat for Executives covering major topics in both clinical design and execution.
