Boulder Clinical Science Research
A contract research organization that delivers
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Services

Full Spectrum

Efficient Clinical Trial Design and Execution across the full spectrum of the regulatory cycle: IDE, IND, Prospective Randomized, Post Market, Retrospective Cohort or Case Series  

  • Biostatistics and Data management with part 11 compliant electronic data capture

  • Monitoring

  • Protocol and CRF Development

  • Investigator Meetings and Advisory boards

  • Site Selection and Enrollment

Pre-Clinical and Bench Design and Execution

  • Experimental Design

  • Cadaver and/or Animal Experiments

Regulatory Support and Clinical Development Plans

  • 510(k), PMA

  • IDE, IND

  • Additional indications or claims language with either new or existing data

Publication Strategy and Medical Writing

  • How to launch your product with evidence

  • Peer Reviewed Manuscripts

  • Abstracts and Presentations

  • Technical aspects of regulatory submissions

  • Marketing Materials