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Anticipating Near-Term Structural Change in the Outsourcing LandscapeCan full-service outsourcing to CROs by large biopharma companies sustainably prosecute a clinical development portfolio?
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The Future of Regulatory Intelligence With Conversational AIChatbots can benefit regulatory landscape in light of evolving standards and guidelines.
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Tackling Trial Diversity Through Higher Innovation StandardsAdvancing responsible AI innovation to help resolve patient disparities.
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Examining the Current Value of ClinicalTrials.gov Listings for Patients and the PublicLooking beyond regulatory compliance.
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CSL Behring and Takeda Discuss Advancing Clinical Development and the Future of TrialsThe conversation took place during the Veeva R&D Summit in Boston.
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Oversight Method Identifies Critical Errors Missed by Traditional Monitoring ApproachesStudy Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.
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Is Japan Leading a New Digital Health Movement?Factors that contribute to Japan's prominent position in the rapidly evolving field of digital therapeutics and why it matters to the global life sciences industry.
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Why Decentralized Clinical Trials Are the Way of the FutureAssessing the opportunities, considerations and implications of decentralized trials—and why they’re here to stay
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The Future of SDTM Transformation: AI and HITLUsing an AI + Human in the Loop (HITL) approach can be utilized for Study Data Tabulation Model (SDTM) transformation, potentially alleviating current challenges
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How Sponsors Can Use Health Decision Science to Improve Clinical Trial Recruitment and RetentionExamining the behaviors of clinical trial stakeholders to better understand challenges in patient participation.
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The MDR: Navigating Europe’s New Standard for Medical Device SafetyEurope’s new Medical Devices Regulation (MDR) is four times longer than the previous Medical Device Directive, and it has raised the bar for clinical evaluations. It’s imperative that manufacturers proactively identify the gaps in their data and take the necessary steps to fill them — from pre-clinical through post-market. Many companies are unprepared for this task. Our guest, Dr. Kim van Noort, will walk us through some of the biggest challenges that MDR poses, and tell us how to overcome them.
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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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Establishing Metrics and Standardization for Non-CRF Data in EDCWhile Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.
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Navigating eConsent Submissions: Who, What, Where, and Why?Unraveling eConsent Ethics Committees and Health Authorities submission document requirements to foster wider adoption.
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Creating an Integrated Digital Pathway for Sites and Sponsors*** Thursday, June 17, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST *** Join this webinar to hear best practices on how to enhance site-sponsor collaboration, compound efficiencies and accelerate trials by enabling end-to-end document exchange between sponsor eTMF systems and Florence’s leading eISF solution through Cognizant SIP. ***On demand available after final airing until June 17, 2022***
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Awareness of Clinical Research Increases Among Underrepresented GroupsLatest CISCRP study provides insight on proactive outreach.
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Real-World Use of an Artificial Intelligence-Supported Solution for Coding of Adverse Events in Clinical TrialsStudy evaluates the use of AI-supported medical coding module.
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Exclusivity or Collaboration in Clinical Trials - What's the Best Formula for Success?*** Monday, May 24, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST *** Most organizations deal with the vulnerabilities that exclusive point solutions create. Join industry leaders Oracle and IQVIA to understand how inclusivity and a flexible environment can help you employ new approaches faster, and the benefits of collaboration in today’s clinical trials ecosystem.*** On demand available after final airing until May 24, 2022 ***
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The Regulatory Requirements and Key Points of Drug Clinical Trials Registration in ChinaFollowing the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.
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How Remote Patient Monitoring Technology Can Impact Decentralized Clinical TrialsWhat is next for DCTs after acceleration from COVID-19?
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The Transformation of Clinical Trials from Writing on Papyrus to the World of TechnologyNew requirements must be put in place to ensure data quality and integrity.
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Regulatory Considerations Surrounding Human Challenge Studies with the SARS-CoV-2 VirusA first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.
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4 Key Actions ClinOps Can Take Now to Avoid DisruptionsBiopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.
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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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Clinical Research Needs Greater Participant DiversityCOVID spotlights the troubling disparity in clinical research representation. How can we remove these barriers?
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Clinical Trial Disclosure and Data Transparency: Obligation or Opportunity?Implementing disclosure and data transparency policies and procedures represents an opportunity for sponsors, rather than an obligation.
