BOULDER CLINICAL SCIENCE, L.L.C.

Capabilities

BCS is a small and efficient contract research and medical writing organization with PhD level clinical scientists, biostatisticians, and master’s degree level monitors with decades of industry experience specific to the therapeutic area of interest. BCS has a successful history of supporting pharmaceutical and medical device sponsors and clinical investigators across a wide range of indications and therapeutic areas, including but not limited to the services listed below: 1. Pharmaceutical and medical device prospective clinical trial design and complete execution including: a. Protocol development b. Biostatistics power and sample size calculations c. HIPPA (part 11) compliant electronic data capture (EDC) with RedCap software with remote monitoring capabilities or client owned EDC software if preferred d. Site and remote data monitoring e. All periodic reports to IRB and FDA f. IRB application and approval