Authors
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Clinical Strategies to Optimize Software as a Medical Device to Treat Mental HealthWith close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.
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Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce2020 Tufts CSDD study examines relationship between investigative site personnel diversity and study participant diversity.
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Confidentiality in DCT: How to Utilize Third-Party Home Health ProvidersAlleviating sponsor and investigator concerns around sharing of remote-assessment data in accordance with GCP and GDPR standards.
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Importance of Diversity in Parkinson’s ResearchEliminating barriers to engage underrepresented populations.
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Real-World Data Offers Significant Opportunities for Developing New Therapies for Hematologic CancersBy integrating real-world data more deeply into the process of clinical research, life sciences stakeholders can open up new possibilities for therapeutic development and the evidence-based treatment of hematologic cancers.
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WiFi Automation Keeps Decentralized Clinical Trials RunningReliable internet connection an integral part of movement to DCTs.
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How Medical Writing and Regulatory Affairs Professionals Can Embrace and Deploy Generative AI at ScaleUnlocking the full potential of artificial intelligence requires these stakeholders to ensure their data are accessible and secure.
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WCG Randomized 1,600 Participants for RSV Vaccine TrialA top 5 sponsor turned to WCG to recruit expecting mothers for its Phase III RSV vaccine trial. WCG support covered multiple countries and contributed almost one third of overall randomizations in the supported countries, bringing the study in ahead of schedule despite delays due to COVID-19 impacts on RSV seasonality. The sponsor met study timeline past enrollment by continuing to work with WCG’s retention support.
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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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Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient EnrollmentOutdated regulations and inflexible sponsor processes are hampering clinical trial recruitment, but empowering sites with modern, compliant marketing tools could turn the tide.
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Building Relationships Key for Smaller SponsorsStrong collaboration critical as trial development advances.
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Accelerating Breakthroughs with Synthetic Clinical Trial DataThe emergence of AI-powered simulants in improving study efficiency.
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Overcoming Operational Challenges in Oncology Clinical Trials: Lessons from a Multicentric Study in IndiaCase study highlights how clinical operations teams can overcome complex regulatory and operational hurdles to finish a trial on time and on budget.
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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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Tokenization: The Unsexy Plumbing of Clinical ResearchAs clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.
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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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Detecting Fraud in Clinical Trials Using Statistical Data MonitoringExploring stat-based testing for variables that identify deliberate data manipulation in clinical trials.
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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 Failure Isn’t an Inevitable Risk—It’s Insurable and Opening the Door to New InvestorsClinical trial failure insurance is turning biotech’s most costly risk into a manageable asset, opening new pathways for funding and innovation.
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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.
