Case Study 4

Rescue of 'At-Risk' Trial H5N1 Vaccine Study / Healthy Volunteer Population

SITUATION

The complexities of coordinated enrolment to meet or exceed timelines are inherent with vaccine trials. Equally essential is the maintenance of high retention rates for quality data results. For this H5N1 Vaccine Study, the initial CRO was unable to accept the contract terms of the Sponsor. The trial execution was further delayed by that CRO’s proposed Investigator Meeting 10 weeks from the contract approval.

CHALLENGES

  • No information was transferred from the previous CRO
  • The study Sponsor had selected an Immunology Lab prior to the assay being validated (the selected lab was unable to validate the assay)
  • TFS had to revisit all pre-identified Alliance For Multispecialty Research (AMR) sites
  • Renegotiation of the Sponsor contract & investigator contracts required
     

TFS SOLUTION

  • Sponsor contract negotiated within 5 days
  • All site contracts renegotiated within 6 weeks
  • Investigator meeting involving all site coordinators & investigators conducted within 8 weeks of Sponsor contract approval
  • With the selection of a new lab (Focus), TFS & AMR adjusted the laboratory procedures for assay validation and amended the protocol accordingly
  • All sites (6) enrolled the allotted Subjects (420) using AMR’s “controlled, competitive” enrolment model and Core Team Concept to facilitate communication
  • Enrolment closed in 4 weeks
     

CLIENT ADVANTAGE

Working with the existing site vendor, Alliance For Multispecialty Research, LLC (AMR), TFS merged its vendor management skills, history of complex trial rescues, and experience in vaccine trials into a focused partnership on behalf of the Sponsor. TFS completed this study on time and under budget with a 95% retention rate, exceeding the Sponsor’s expectation of 85%.