April 23, 2018
  • Clinical Trial Patient Inclusion and Exclusion Criteria Need an Overhaul, Say Experts
  • HHS Proposes Common Rule Delay and Asks for Comment on Burden Reduction Provisions

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April 16, 2018
  • EU General Data Protection Regulation (GDPR) Enforcement Set to Begin on May 25
  • FDA Releases Guidance on Next-Generation Sequencing with an Eye on Easing Path to Market
  • FDA Releases Final Guidance for Special Protocol Assessments

 


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April 9, 2018
  • Woodcock Outlines Changes Needed to Connect Clinical Research and Healthcare
  • Industry Approaching Inflection Point in Consolidation Towards Large Health Systems

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April 2, 2018
  • Mandated Restructuring of Informed Consent Documents Could Help Guide Patient Decision-Making
  • Best Practices in Site Feasibility Studies Can
    Set the Stage for a Healthy Trial

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March 26, 2018
  • FDA Releases First Clinical Study Report in Data Transparency Pilot Program
  • Rare Disease Clinical Trials May Require Paradigm Shift Away From Traditional P-Values to More Adaptive Models, Experts Say
  • FDA Previews Pilot Program to Provide Early Regulatory Review of Innovative Trial Designs

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March 19, 2018
  • Small Biopharma Companies Must Wrestle With Big Safety Data Responsibilities
  • Electronic Storage of Work Correspondence – GCP Questions, FDA Answers

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March 12, 2018
  • National Academies Workshop Suggests Principles for Use of Real-World Evidence
  • Tufts CSDD: Clinical Trial Startup Process Takes Longer Than 10 Years Ago
  • CTTI Investigates Barriers to Conducting Pediatric Antibacterial Clinical Trials

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March 5, 2018
  • Challenges Become More Concentrated in Gene Therapy Development, Experts Say
  • Mayo Clinical Reports Treatment Benefits May Be Exaggerated in Early Clinical Trial Results
  • Free Online Transparency Tool Tracks Clinical Trials Reporting Compliance

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February 26, 2018
  • FDA to Require GCP Compliance for Device Trials Conducted Outside the U.S.
  • Early Chart Reviews Can Provide Steady Flow of Potential Study Subjects, Experts Say

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February 19, 2018
  • SCOPE 2018: Advances in Big Data, Patient Centricity Could Shift Sponsor, CRO Relationships
  • Sensors and Wearables Transform Clinical Trials but Challenges Remain, Experts Say

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