101 participants in five weeks as a rescue site network

The situation

The sponsor was behind on enrollment and needed additional capacity late in the study. Hawthorne was brought in as a rescue partner, which meant standing up six community sites against a timeline set by a study already in flight rather than by a normal start-up schedule.

Rescue work is a different problem from volume work. The sponsor was not buying our total capacity. They were buying how quickly that capacity could be pointed at their protocol. Sites were activated fourteen days after the contract was signed, with site initiation visits running close to the signature date.

What made it difficult

• Activation was staggered rather than simultaneous, so sites came online across a window instead of on one date.
• The inclusion and exclusion criteria did not map cleanly onto the pharmacy patient databases, so the pharmacy referral channel could not carry recruitment on its own.
• Staffing had to be locked in against a timeline that moved while the study was running.

What we did

• Placed coordinators on site full time at each location, functioning as site directors rather than visit-level coordinators, with direct authority over pharmacy and investigator teams.
• Ran recruitment centrally across community outreach, digital, and pharmacy referral together, rather than leaving each site to source its own candidates.
• Kept every pharmacy partner engaged in recruitment throughout, with weekly and in several cases daily contact.

Result

Six community sites enrolled 101 participants across five weeks of active enrollment, with 101 of 124 screened participants going on to enroll. Every pharmacy partner in the network contributed referrals.

The engagement also served as a full-scale test of the operating model. Three findings were carried straight into how the network is staffed and run: coordinators on site as site directors is now standard for pharmacy-embedded studies, investigational product handling is a distinct training module delivered before activation rather than during it, and site staffing moved from fully variable to a semi-fixed model so availability is locked before a study is awarded.