Cleopatra -
Rescued heart failure trial

Project description:

ProjectPharm was approached to rescue a study in heart failure. The study was originally to recruit 780 patients with heart failure within one year. One and a half year after recruitment start 67 patients had been included in the study.

ProjectPharm’s mission:

Complete recruitment in less than one year, and keep the budget as low as possible (the original budget was 2.4 MEUR, the current service provider had submitted a change request of 7MEUR for completing the study within 7 years from that point on)

ProjectPharm’s approach:

After a thorough gap analysis directly at the sites a project plan was created, including three waves of recruitment acceleration measures – immediate actions at already active sites, starting up promising new sites where the regulatory hurdles would be relatively low, as well as including highly promising new countries, which would however require a longer start-up period.

Eventually, recruitment was completed with a slight over-recruitment of 33 patients, 9 months and 15 days after the start of the rescue project, with a final cost of 2.5 MEUR, which was the anticipated budget.

This achievement was possible through the involvement of a smaller, local CROs, acting – together with the original CRO and its respective vendors, with an external consultant responsible for scientific and regulatory issues, and with ProjectPharm being responsible for coordinating and leading the project as a whole, ensuring that all team members acted as one team, though being employed by very different service providers, acting across several a huge geographical area.

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