Case Study

Phase II Primary Insomnia Program In Need Of Full-Service CRO Management

Source: CliniLabs

Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program. The sponsor selected Clinilabs for a variety of reasons, including expertise in the _eld of sleep medicine, established CRO infrastructure, and the ability to identify high-performing investigator sites in the _eld of sleep medicine.

Clinilabs worked closely with the sponsor to design a study that would meet approval with regulatory agencies. We then completed a feasibility survey to identify a small group of investigators in the US who had prior experience in insomnia trials. From its prior experience, the sponsor expected to utilize 12 research sites for this program. However, based on the experience of the sites Clinilabs identi_ed, 9 sites were activated, which saved a substantial amount in study management expenses.

Following the study award, Clinilabs assembled an exceptional study team, including an experienced project manager, medical monitor, clinical monitors, data managers, biostatistician, and medical writer, and appropriate sub-vendors were identi_ed (e.g., IVRS system, clinical laboratory, drug importation).