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How Life Sciences Companies Can Strengthen Regulatory Submissions With External Control ArmsData from past clinical trials has provided researchers with a good starting point to create more ECAs.
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Decentralized Clinical Trials Bring Research to the Patient—in More Ways Than OneDCTs proving to solve numerous pain points for patients in clinical research.
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Virtual Clinical Trials Post-COVID-19: Collaboration Will Be Key to SuccessThe use of virtual trials will surge in the future and could become the de facto standard for clinical studies, says a recent Pistoia Alliance poll.
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The EU Regulations Catching US Pharma Companies Off GuardCompanies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.
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Changing the Paradigm in AI ImplementationHow pharma companies can reduce the risk of failure with AI-based innovations.
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Putting Labeling on the Boardroom AgendaHow smart packaging can aid clinical trial adherence.
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Using Clinical Trial Sites' Input to Select the Right Capabilities when Decentralizing Clinical TrialsThis paper analyses the responses from more than 800 US-based clinical trial sites to understand their decentralized clinical trial capabilities and perceptions
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Adapting Site Selection for Clinical Trial Decentralization and the Future LandscapeSites not expected to fade away even as DCTs continue to grow past COVID-19.
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How Clinical Trial Research Sites Can Gain Access to a More Level Playing FieldTo overcome sponsor-related challenges and work to successfully secure more trials, there are tactical steps CROs can take.
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Modernizing Data Management in the D-Clinical Age***Live: December 9, 2020, at 11am EST| 8am PST| 4pm GMT| 5pm CET*** In this ‘D-Clinical Age’, leveraging modern technologies and new approaches and mind sets is required to accelerate the development of new treatments. This webinar will examine how data management can drive digital transformation with the right mix of technology, skills and process redesign.***On demand available after airing until Dec. 9, 2021.***
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Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.
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Designing Cell Therapies to Target Solid TumorsA look at one company’s platform approach in enabling the engineering of T-cells to identify and destroy cancer.
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Datopotamab Deruxtecan Biologics License Application Accepted by FDA for NSCLC Based on Phase III Trial DataDatopotamab deruxtecan, the first TROP2-directed DXd antibody drug conjugate, is being evaluated for locally advanced or metastatic nonsquamous non-small cell lung cancer.
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Considerations for the Effective Rollout of DCTs at a Global ScaleFor effective rollout on a global scale, sponsors must address and develop a plan around known challenges including recruitment, sit adoption, and technology integration.
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Regulatory Data: How Technology Can Help ClinOps SurviveClinical operations professionals, burdened by lack of data standardization, turn to technology in hopes of streamlining regulatory processes for the future.
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Guide to Incorporating Modern Research Tools and TechniquesThis piece offers a practical assessment of leveraging various decentralized methodologies and technologies.
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Adapting Site Selection for Clinical Trial Decentralization and the Future LandscapeSites not expected to fade away even as DCTs continue to grow past COVID-19.
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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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Advancing ICU Care with eConsentComplicated process of consenting ICU patients can be simplified with a well-designed eConsent platform.
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Is Trust the Secret Ingredient for Digital Product Success?To rebuild trust, companies should focus on transparent, neutral content incorporating medical expertise and regularly seeking HCP feedback.
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Virtual Trials Save the DayVirtual trials tools are usually selected early in the protocol development stage, however, due to the COVID-19 crisis, regulators are encouraging sponsors to consider integrating virtual elements into clinical trials already in progress.
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Steps Toward Diversity in Clinical Trials: Building Authentic TrustBuilding authentic trust lays at the heart of creating more patient-centric trials.
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Harnessing the Power of Scientific SurveillanceStatistical methods used via this technique in centralized monitoring.
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A Cross-Sectional Study of Patient Perspectives on Clinical Trial Participation in a Large Community-Based Research FacilityAn overview of patient perceptions of cancer clinical trials and the consent process among those who are currently enrolled in, or who recently completed, a cancer clinical trial.
