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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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How Digital Will Transform Product Development in 2022 and BeyondPandemic sparks new long-term plan for success in R&D.
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Evolving Toward Empowerment: How We Are Deepening Relationships With PatientsMultilayered strategies such as working with patient advocacy organizations and leveraging technology can help industry better partner with patients.
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Proposed ICH-GCP E6(R3) Guidance: Principles in ActionHow to support trial investigators through decentralization of trial elements.
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Rise of the Activated Patient During COVID—Biopharma on NoticeSparked by the pandemic, patients are now leveraging remote technology to take control of their healthcare.
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Enabling Evidence-Based Study Endpoint SelectionHarnessing advances in digital health technologies for a more precision-measured approach.
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Shifting Perspectives on Site Networks to Create Positive ChangeEvaluating the lessons learned about trial sites from COVID-19 to form new strategies and improve patient safety for the future.
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COVID-19 Will Have a Heterogeneous Impact on Clinical Trials, BiopharmasA discussion of how the coronavirus pandemic will have a multitude of impacts on the conduct of trials, as well as on the industry itself.
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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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AI-Enabled Clinical Trials: A Multiomic Roadmap to SuccessHow artificial intelligence can aid in selecting patients, leveraging safety insights, and optimizing combination therapies.
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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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Moving Beyond the Checkbox Approach With Risk-Based Quality ManagementWith risk-based quality management (RBQM), the industry is uniquely positioned to amend Murphy’s Law and propose something new—“Everything that can go wrong, we can work to identify and prevent.”
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Sharing Clinical Trial Results with Pediatric ParticipantsSurvey uncovers pediatric-patient perspectives on plain language summaries.
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An Overview of FDA Diversity-Related Documents for Clinical TrialsThere is significant potential in decentralized models and digital health technology to expand diversity in clinical trials.
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We Must Do More to Ensure Women Achieve Their Professional GoalsWith poor retention of women in the biomedical workforce amid the pandemic, industry leaders in clinical research must step up to provide solutions.
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Turning a Struggling Clinical Trial AroundHow to assess common obstacles for opportunity and create more agile and adaptive clinical trials.
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Better Qualification Strategies, Better Patient Recruitment OutcomesAs the clinical trial recruitment landscape continues to evolve, patient recruitment remains a critical challenge. More innovative screening strategies can improve recruitment and enhance the quality of clinical research.
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Managing Clinical Trials During the COVID PandemicHow one CRO in India quickly implemented processes and technology to mitigate risk
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Notable Discussions from SCOPE 2025: Aiming to Calculate, Accommodate, and Innovate for Enhanced Drug DevelopmentThis year’s conference highlighted a number of critical areas in clinical R&D including financial management, representation, and eCOA.
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How COVID is Forcing a Reckoning in Respiratory Clinical TrialsPandemic has brought new sense of awareness to respiratory diseases and clinops.
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COVID-19 Pandemic Exemplifies the Benefits of CROsThe adaptability and innovative capacity of CROs highlighted in EUCROF survey.
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Where Do We Go From Here?Lessons from six months of conducting clinical trials during the COVID-19 pandemic
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What Does Racial Color-Blindness Mean for Clinical Trial Participation?Research collaboration between Tufts and the Society for Clinical Research Sites explores the prevalence of this belief in healthcare.
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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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How Remote Patient Monitoring Technology Can Impact Decentralized Clinical TrialsWhat is next for DCTs after acceleration from COVID-19?
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Tailored Patient Involvement in Clinical TrialsThe approach of the Cancer Research UK Centre for Drug Development.
