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Program Management

Case Study Background:

A sponsor was planning on initiating two global Phase 3 studies, ~300 patients each, for their Dental soft tissue anesthetic reversal compound. Prior to starting, the FDA requested that a number of additional trials be conducted, including: two pharmacokinetic (PK) trials (one in pediatrics and one in adults), a validation study of the functional battery test and a 150 patient pediatric trial. Because of the additional studies requested by the FDA the clients needed a CRO that could quickly and efficiently execute these trials to meet their timelines and budget. Because of our expertise and experience in dental research the sponsor contract with InClin to manage the program of six studies.

InClin’s Approach:

  • To work with the sponsor to develop a clinical development plan to conduct the trials in the correct order and within their timelines
  • The pediatric PK trial was put on critical path development to prevent a delay in submission due to the fast patient enrollment on the Phase 3 studies
  • Assembled an experienced team to execute and manage the trials in close coordination with the sponsor and investigative sites

InClin’s Actions Taken:

  • Developed a training video for the site staff and patients to demonstrate proper technique for the functional assessment battery testing and soft tissue anesthetic reversal assessments
  • Identified investigative sites that could enroll pediatric patients in a timely manner in addition to the academic sites requested by the sponsor
  • Expedited study start up activities. Identified, contracted, gained IRB approval, and initiated a site in one week to start enrollment immediately
  • Performed FDA audit readiness preparation at the investigative sites

InClin Results:

  • The Phase 3 trials were finished three months ahead of schedule
  • The pediatric trial was finished six weeks ahead of schedule
  • Successful sponsor audit
  • FDA approval of a new compound and marketed product