August 5, 2019
  • FDA, ICH Seek Comments on “Quality by Design” Draft Guideline
  • Consistent AE Review and Assessment Critical to Successful Device Trials

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July 29, 2019
  • Simple on the Surface, Complex Underneath: Lessons from a Real-World Trial
  • Easy Document Access Key to Inspection Success, Expert Says

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July 22, 2019
  • Regulators, Industry Still Have Not Reached Consensus on Risk-Based Monitoring
  • Sites: Make Financial Audits Work for You

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July 15, 2019
  • Role of Real-World Evidence in Clinical Trials Needs Definition, Industry and FDA Agree
  • Ask the Experts: Consent and Reconsent

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July 1, 2019
  • Sponsors Need Vendors’ Metrics to Select the Best
  • Preparing for the Unexpected is a Team Effort

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June 24, 2019
  • Improve Trials with Integrated Electronic Systems Instead of Information Silos, Survey Says
  • Reduce Risk, Increase Efficiency by Centralizing Site Operations, Experts Say

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June 17, 2019
  • The Art and Science of Site Monitoring Visit Reports
  • Expert Q&A: Effective Patient Recruitment

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June 10, 2019
  • Broaden Criteria to Maximize Trial Results, FDA Says
  • Managing Risk Means Measuring the Right Things, Experts Say

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May 27, 2019
  • Market Value Should be “Defendable, ”Not “Fair,” Experts Say
  • Lack of Training Compromises Trial Results, Expert Says

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May 20, 2019
  • Risk-Based Monitoring Should Be Best Practice, ACRO Tells FDA
  • Security Breaches Getting Harder to Spot, Expert Says

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