Case Studies for Data Management

Independent Physician Review

Health Policy Associates Inc. recently completed a project with a public company specializing in cosmetic indications requiring performance of all data management functions, including coordinating an independent physician review of the results. Efficient performance and timeline management was required after last patient follow-up in order to meet product approval milestones required by public disclosures. By employing additional resources and adapting our data management process to work with live data upon receipt, HPA Inc. was able to complete the following within a one month time frame:

  • Processing physician evaluations
  • Data entry, query resolution, and statistical analyses
  • Production of a clinical study report for submission to FDA within two weeks of receiving the final shipment of Case Report Forms

Clinical Study Rescue

Health Policy Associates Inc. was engaged by a device manufacturer developing spinal implants to assume data and study management responsibilities for three multi-center pivotal clinical studies. The studies had been conducted in a manner not compliant with FDA and GCP guidelines, and this company retained Health Policy Associates Inc. immediately after the issuance of Warning Letters by FDA. HPA Inc. assisted the company in the development and implementation of a comprehensive corrective action plan that included: (a) drafting and issuing new clinical standard operating procedures, (b) training new clinical personnel, (c) auditing all clinical sites, (d) resolving all data discrepancies and queries, (e) developing several Part 11 compliant databases and (f) entering and analyzing cleaned data for FDA submission. Throughout the process, HPA Inc. managed all aspects of regulatory communications without further sanctions being imposed on the company and within twelve months had:

  • Addressed and resolved all outstanding non-compliances
  • Produced three final clinical study reports for submission to FDA
  • Assisted the company in creating an entirely new clinical department and program designed to efficiently conduct compliant clinical studies in the future

Health Policy Associates Inc. involvement increases probability of success in both financing of and execution by privately financed companies.