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Latest:
Four Key Trends for Identifying Regulator and Payer Evidence Needs in Oncology Drug DevelopmentHow to leverage novel trial designs and real-world data to support a cancer drug submission with an evidence strategy that is both approvable and reimbursable.
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Clinical Study Audits: The Quality Management ApproachAdvancing risk-based auditing one step further by identifying the underlying process deficiencies to enable improved corrective and preventive actions.
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Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial DataPresenting how data transformation is measured as part of the SAFE Data Standard, which data variables influence the rating and, how the appropriate level of data transformation is calculated.
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DMCs: Maintaining Data Integrity in COVID-19 ClimateRegulators are urging the use of data monitoring committees to support clinical trial management and decision-making during pandemic.
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Q&A With Daniel Lofaso, CEO of Digital ElevatorIn this Q&A with Applied Clinical Trials' sister brand, Pharmaceutical Executive, Lofaso discusses marketing strategies for early-stage biotech companies, including how they can effectively recruit patients for their clinical trials.
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At-home Self-collection of Blood Specimens for Safety Lab Testing in Clinical Trials via the Tasso+ DeviceLaboratory services organization focuses on easing patient and site burden with improved collection device.
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Establishing a Basis for Secondary Use Standards for Clinical TrialsStudy seeks to understand how different forms of data meet the needs of researchers.
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Optimal COA Measurement Strategy in Modern Oncology TrialsExamining the two areas of weakness cited in FDA draft guidance.
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Introducing PALADINFirst-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.
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Managing Clinical Trial AgreementsHow Clinical Research Malaysia sped up CTA turnaround using a web-based system.
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Getting to Clinical Trial DiversityDiffering levels of trust in clinical trials information channels across diverse populations is examined in this research.
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Creating Future-Ready Teams for Digital Clinical TrialsThe need for specific capabilities to suit DCT business models is creating new challenges in team building, training, and development.
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Revamping Site Feasibility as Trials Become DecentralizedHow asking better questions and leveraging site databases can expand access to more patients.
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How to Operationalize Infectious Disease Trials with a Virtual SiteIn this playbook, learn how a virtual site solution expands access to infectious disease clinical trials by allowing patients to enroll and participate from anywhere.
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The ICR-CRM-IQVIA Research Network Collaboration ExperienceA discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.
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eSource Interoperability Between EHR and EDCEvidence from a Phase III cancer trial points to notable advances in data-transfer tech.
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Pandemic Challenges and Opportunities for Gender Equity in Clinical ResearchIndustry must act now to minimize effects of COVID-19 on clinical research.
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eSource Interoperability Between EHR and EDCEvidence from a Phase III cancer trial points to notable advances in data-transfer tech.
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Debunking Top 5 Myths about Digital Twins in Clinical TrialsAddressing misconceptions as industry becomes more familiar with AI and ML.
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Microbiology is Vital to Compliance to Annex 1 and Risk-Based RegulationThe revision of Annex 1 clearly calls out the use of quality risk management to identify potential risks to quality and the implementation of a contamination control strategy.
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6 Steps During Pandemic to Support the Needs of Patients and SitesThe latest FDA and EMA guidelines permit sites, sponsors, and CROs to adjust their operations to meet changing conditions for ongoing trials, including some concerning the safety of participants, that must be met in order for new solutions to be considered.
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Employing the Power of Bayesian Methods to Expedite LearningBayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research.
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Innovations in Data Capture Transforming Trial DeliveryAdvances in technology open door for improved EHR to EDC transfer process.
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Navigating Clinical Trial Recruitment in the Midst of COVID-19Many companies during this time of social distancing have paused trial recruitment completely to focus on currently recruited patients, while others rethink their strategy to better accommodate the new digital-only reality.
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FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug DevelopersJanuary 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.
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Integration of Biomarker Validation in Oncology TrialsRecent case study highlights the importance of applying statistical rigor throughout the development and validation processes of biomarkers.
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Evolution of the UK Legislative Framework for Clinical TrialsNew proposals aim to create higher standards for trial regulation.
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Rare Disease Clinical Trials: Strategies Learned from Duchenne Muscular DystrophyApproaches sponsors, CROs, and investigators can take from the DMD experience.
