Ridge Rim Associates, LLC. Regulatory Documents ~ Clinical Publications

Cascade Mountains Photo by Paul Long

Clinical regulatory documents

  • Briefing documents
  • Integrated summaries of safety, efficacy, and clinical pharmacology
  • Investigator brochures
  • Study reports, Phases 1 – 4
  • Protocols and associated documents

Clinical publications and presentations

Data review and analysis, pre- and post-database lock

  • Review of patient profiles before database lock, to identify potential issues that could be resolved with queries
  • Evaluation of draft statistical output, to identify apparent inconsistencies and potential data gaps
  • Critical analysis of final data, to facilitate interpretation

Roberta Connelly, Principal | roberta@ridgerim.com

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