case study


The Case

  • Project Cost: $2,100,000 (2 years)
  • 100% of the CRO team had advanced degrees & licensed professionals (full time team included at least 3 MDs, 2 PhDs as well as MS regulatory and engineer graduates)
  • Cost Per CRO Team Member: Less than $100/hour
  • Project Duration: 2 years
  • Project entirely conducted in the United States

The Situation

  • Cross‐ Functional Technical Team Required: RxRS CRO was selected by the Client to assemble a team of engineering, regulatory affairs, scientists and medical contract workers who could work well together on the technical review, analysis and interpretation of safety information.
  • Technical Writing Required. This team needed advanced scientific expertise to review the data and engineeringrelated device components / design, and needed linguistic and technical writing skills to appropriately narrate, scrutinize and breakdown the evaluation associated with the research study’s ongoing developmental and safety investigation.
  • Quality Professionals with Compliance Audit Skills: For this one study project, it was anticipated that at least 200 sites involving over 8,000 subjects had “unclean” data with inconsistencies and discrepancies as commonly associated with raw, un‐validated and often times handwritten data.
  • Scientific Expertise: Critical to providing engineering and technical analysis for this type of project, each contract worker had to understand the medical and scientific principles behind the research protocol so as to properly evaluate and assess the impact of the data and the its implications for the company’s research, development and safety efforts. This team was also tasked with managing Client safety data requests, executing data queries, performing statistical analysis and adjudicating data claims on a routine basis.
  • Host Facility Operations Required: The Client also needed a supplier who could personally manage and operate the team at the supplier’s facility with supplier computer systems and equipment – outside of the Client’s California headquarters.
  • Data Secure Systems: Security systems (facility and computer), data protections and overall accountability had to be in place as the Client’s confidential data required sophisticated protections.
  • Little or No Budget Planned: And, the Client’s budget was extremely limited as little funds had been budgeted for this unanticipated project’s expense.

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