Client success story — pharmaceuticals

Company profile

Large pharmaceutical company

The challenge

The company needed to expedite a Phase III study consisting of 6 protocols in 28 countries and 36 languages, involving 350 clinical sites and 2,100 patients. They sought a partner to provide innovative technology, an efficient process, clinical healthcare expertise and an expansive global network to shorten the enrollment process and bring the study to completion within a very aggressive timeframe.

RR Donnelley was charged with facilitating a seamless execution of the multidimensional program to recruit and retain subjects over the 2-year study cycle. This included:

• Rapid development and management of a comprehensive set of materials for all 6 protocols requiring 2100+ pieces
• Translation of all materials into multiple languages
• Localization and customization for individual sites worldwide
• Gaining numerous legal and regulatory approvals
• Printing and global distribution of materials

The solution

To manage and speed the approval process with all relevant regulatory boards, RR Donnelley utilized Venue, a central, proprietary, online repository for the secure exchange of confidential information. E-mail alerts quickly notified regulators of materials posted to Venue and provided secure hyperlinks for the immediate access, review and/or editing of the appropriate materials. Advanced reporting features allowed RR Donnelley to track who accessed what information when, and ensured timely follow-up and resolution to further streamline the process.

RR Donnelley’s online web-based distribution and program management system, CustomPoint, enabled direct connectivity with 350 clinical study sites worldwide and provided access to a wide range of study-related materials. CustomPoint allowed sites to quickly customize, (re)order and receive hard copy materials as well as download training programs, advertisements, video and radio spots as needed. Instant access to activity reports helped sites monitor progress and reshape the program for optimal results.

The results

The study concluded three months ahead of schedule.
Results are as follows:

• Campaign rollout plan maximized resources based on-site initiations and IRB/EC timeframes
• Site and retention programs were managed through global web-based systems
• Materials were developed, translated and customized on time
• IRB and ethics committees approved 97% of materials with no edits
• Expeditious material delivery to sites enabled an on-time start date
• Discontinued rates were well below industry averages