Case 2: Small Device Company

CSTI Case Study: Clinical Program Course-Correction

Company: Small Device Company
CSTI Objective: Define clinical program and implement clinical studies to prevent further timeline slippage and funding delays.

SITUATION

  • Investigational device exemption (IDE) application and subsequent clinical studies were behind schedule
  • Management and board requested intervention to expedite the execution of the clinical program
  • Clinical program not defined: Scope and sequence of each clinical study through Proof of Concept (POC) was not clearly defined
  • Sponsor staff wanted to retain control over study execution but did not have experience with the execution of clinical studies conducted under US Federal Regulations
  • No operating infrastructure for clinical study implementation and minimal funds available for implementation

SOLUTION - CSTI Clinical Trial Management Services

  • Through consultation with clinical and regulatory team, designed clinical program consisting of a series of studies including objectives and endpoints designed to establish Proof-of-Concept (POC)
  • Prepared plan for execution of the program, including: budget, timeline and milestones, and reported variances to stakeholders and board throughout the program
  • Prepared clinical SOPs for study Sponsor to enable Sponsor to retain control over study execution
  • Provided clinical study execution training for Sponsor staff
  • Designed clinical documentation templates and implemented quality assurance processes, to ensure that clinical study documentation met industry standards, including: Investigator’s Brochure, study protocol, data collection tools, study reports, monitoring reports, subject recruitment documentation and subject instructions
  • Provided management and oversight during the entire program, ensuring execution according to plan

RESULTS

  • Successfully implemented a series of clinical studies in an expedited fashion
  • Minimized the timeline to determine POC
  • Significantly reduced clinical study management expenditures by training and augmenting Sponsor staff and minimizing the use of contract staff
  • Produced high quality clinical data and reports included in due diligence packages for a number of potential partners and acquirers, helping Sponsor successfully sell asset to major device company