Site Services and Initiation

Prologue’s Site Operations Group plays a vital role in maintaining and nurturing relationships with clinical investigators and site networks capable of conducting high-quality oncology clinical research. Prologue uses standardized procedures to qualify potential investigators, while considering the study-specific requirements and the sponsor’s preferences. Prologue’s experience in managing oncology trials has allowed us to develop long-standing relationships with investigators and this provides an advantage to our clients.

The Site Services Group provides:

• Rapid, cost-effective study initiation.
• A multi-faceted approach to investigator selection that draws on Prologue’s proprietary investigator database, sponsor recommendations, commercial investigator databases, reviews of recently published authors, and relevant health care organizations.
• Extensive knowledge of performance metrics regarding private practice, group practice, clinics, academic medical centers, and site management organizations (SMOs).
• Essential Document Maintenance – A dedicated staff coordinates the collection, review, and tracking of essential documents. This assures that the trial master files are kept current. The team also handles the distribution of study-related materials to the sites.
• Clinical Trial Agreement Execution – Experienced staff to manage contract and budget negotiations. Prologue’s experience with the oncology sites allows us to anticipate requests for certain contract language changes and proactively work with our clients in developing alternative language in advance. This proactive approach fuels rapid study initiation. Additionally, Prologue maintains information regarding current health care costs and oncology research grants; this allows our staff to work collaboratively with the site and sponsor in establishing and negotiating budgets.
• Investigator Payments – The contracts management staff work closely with the project managers to facilitate timely, accurate payments to investigators and institutions.