Authors
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Transforming Research: The Intersection of Ethics, Biosafety, and InnovationIncreased interest in cell and gene therapies has led to increased demand for expertise to help sponsors, CROs, and sites coordinate human gene transfer (HGT) research. Compared to clinical trials with older, more traditional classes of drug products, there are important similarities and differences in requirements for safe and ethical conduct of clinical trials of gene therapy and related modalities.
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Integration of Point-of-Care Devices in Clinical TrialsA look at the future of clinical trial laboratory testing amid the emerging use of new devices at the point of care.
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Building Relationships Key for Smaller SponsorsStrong collaboration critical as trial development advances.
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Future of Clinical Trial Documentation Management: eTMF Integrated with BlockchaineTMF-blockchain technology offers a myriad of application benefits to data quality and integrity while ensuring compliance to ethical standards.
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Making Clinical Research More Equitable Makes for More Effective MedicationsDecentralized trials provide promise for lowering barriers in participation, but industry must continue to be proactive in patient centricity.
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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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Towards Data-Driven Clinical Trial Planning and StrategyOptimizing feasibility through increased data collection.
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Somatic Cell Therapy—Navigating the Regulatory LandscapeThe diversified sources of the somatic cells call for additional oversight to prevent the introduction, transmission, and spread of communicable disease.
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Moving Toward the Pharmaceutical Industry of the Future with Translational MedicineGabi Hanna, MD highlights the need for an effective therapy for acute pancreatitis.
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Enabling Digital Transformation: Managing External Clinical Data Sources to Advance Drug DevelopmentWith an increasing amount of diverse data that must now be collected and analyzed, the industry is faced with increasingly complex studies that present new challenges in data management.
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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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Clinical Trial Diversity in Action: A Site Roadmap for Sponsors and CROsWebinar Date/Time: Wed, Oct 30, 2024 11:00 AM EDT
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C-Suite Survey Underscores Digital Technology’s Growing Role in Clinical TrialsFindings from the most recent Biopharma Confidence Index show that the pandemic has substantially influenced biopharma executives’ expectations in key areas like artificial intelligence/machine learning and real-world evidence.
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How NLP, OCR, and Social Graphs Accelerate Subject Recruitment for Clinical TrialsExplore how natural language processing and social graph techniques help to tackle the challenge of patient and investigator recruitment and raise the success rate of clinical trials.
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Increasing Clinical Trial Diversity Through Patient-First Payment OptionsPatient-first trial design, based around the tenets of adaptability and personalization, has emerged as a key solution to increase diversity and improve trial outcomes for all.
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Clinical Trial Feasibility ObservationsChanging the expectations of the feasibility study can improve the process.
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Enhancing Trial Master File Quality With Pareto Charts and Funnel ChartsHidden costs have industry searching for ways to not only identify quality issues, but completely eliminate them from the start.
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The Consequences of Underrepresentation in Clinical Trial DesignA representative sample patient population that accurately reflects the overall population is vital to establish the safety and efficacy of a drug.
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Introducing Sustainability into the Clinical Trial Supply ChainIdentifying areas of burden and steps supply chain operators can take to alleviate them.
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Clinical Trials in Ukraine During the WarIndustry must take steps in preserving data for use after the war.
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De-Risking Trials with Science-Driven OversightIdentifying the ‘significant six’ areas of clinical study conduct to mitigate risk.
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Overcoming Challenges in the Development of Antibody Drug ConjugatesFor antibody drug conjugates to reach their full potential, developers should focus on addressing current challenges such as safety and efficacy.
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Accelerating Clinical Trial Design and OperationsFully-integrated, component-based CDMS offers flexibility, customization, and efficiency.
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COVID Challenges for Trials in Low-to-Middle-Income CountriesOutlining the five critical hurdles faced by clinical teams conducting studies in these nations amid quarantine and other restrictions.
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10 Questions to Consider With eTMF Vendor SelectionThe many different shapes and sizes of vendors requires a thoughtful process for selection.
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How NLP, OCR, and Social Graphs Accelerate Subject Recruitment for Clinical TrialsExplore how natural language processing and social graph techniques help to tackle the challenge of patient and investigator recruitment and raise the success rate of 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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Assessing Sponsor Attitudes Toward Retail Pharmacy Involvement in Clinical Trial Recruitment and ExecutionAmid CVS’ surprise exit from the clinical research space and the ensuing broader questions, study investigates the benefits of pharmacy chain involvement—along with the concerns and barriers to adoption.
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Using Real-World Data in Patient RecruitmentGrowing availability of RWD leads new drug development process.
