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43 results on '"Mitchel, Jules"'

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1. Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer

2. The Transformation of Clinical Trials: From writing on papyrus to the world of technology

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Books, media, physical & digital resources

3. Analysis: FDA's COVID-19 Accelerated Pathways: Lessons learned from FDA's current process and proposed alternative review strategies

8. Regulatory Considerations for Digitally Driven Trials

9. eSource records in clinical research: keeping it simple: how to satisfy regulatory concerns about EDC data integrity and site controls over its source records

10. WHAT IS A CRO?

15. Three-pronged approach to optimizing trial monitoring: study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry

17. Risk-based approaches: the eClinical Forum risk based monitoring taskforce offers some best practices for ensuring clinical data quality

18. Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative

19. The final eFrontier: challenges and opportunities of integrating electronic data capture with electronic health records

20. The critical path initiative meets medical devices: interaction is high on FDA's list of ways to improve the development & review process for technologies

22. Impact of IBCTs on clinical trial efficiency: this case study shows how Internet-based clinical trials improve data entry, monitoring, and management

24. Meeting the challenges of Internet-based clinical trials: in addition to new efficiencies, Internet-based clinical trials introduce new responsibilities for clinical research teams and investigators alike

25. Clinical trial data integrity using internet technology to collect reliable data: electronic data capture can be invaluable to speed clinical development processes. A recent study demonstrates the reliability of data collected by this method

26. Electronic Data Capture in Clinical Trials using Service Providers

27. Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

29. Paper vs. Web

30. Regulatory Considerations for 21st Century Paperless Trials.

34. Risk-Based Monitoring.

36. Adopt eSource Solutions

40. Risk-Based Approaches.

41. The Final eFrontier.

42. FDA relations during drug development

43. Regulatory Considerations are Key in eSource Data Integration.