Case Study #2

150 patient, 15 site study with a women’s health indication. Neozene had no prior direct therapeutic experience but relationships with key investigational sites. Originally cast as a pilot and pivotal phase project that needed completion within 12 months, a sponsor decision to seek FDA guidance after the pilot phase resulted in an extension of one year on the project. Neozene leveraged relationships, pivoted resources and enacted several process amendments to ensure no budget amendments were required despite the 12 month study extension. Upon study restart, with proper planning and resourcing, 100 patients were enrolled in four weeks achieving critical milestones on time and under budget. The client was able to file the NDA eight weeks early and save nearly $1.0MM from the overall budget. How did we do it?

1. Utilized vested and leveraged relationships with sites to ensure commitment, despite delays, upon study restart.
2. Streamlined processes, enacted risk based monitoring and other efficiencies to preserve budget and ensure sponsor was able to support the program. Absent budget efficiencies, the sponsor would have been required to abandon the project.
3. Incentive Programs: incentivized site staff for the commitment to elevate focus on this project for the desired enrollment period. Sites were given a limited timeframe to achieve desired metrics.
4. Competitive enrollment and frequent communication regarding it.