People. Passion. Performance.Working together to advance treatments in oncology

Situation:

A Mid-size Pharmaceutical company outsourced the global management of a large, 16-country, 200 site Breast Cancer program, consisting of two study protocols, to a large CRO (“Primary CRO”). The CRO was responsible for global direction of the study, clinical operations in Europe, Asia PAC and South America, global medical monitoring and global data management. The Sponsor brought on another small SMO/CRO to handle site management and site monitoring for selected sites in the United States.

Challenges:

The study was lacking consistent, global leadership and key staff members had little oncology experience. Communication and reporting was disjointed and the Sponsor felt the success of the program was at-risk during the critical “start-up” phase of the study. The CRA turnover rate at the large CRO was unacceptably high.

Solutions:

The Sponsor transitioned global project direction of the study to ACT and placed ACT in the position of the ‘Primary CRO’ on the program. ACT transitioned onto this program and established the following:

‣ Consistent leadership over the global program, including the implementation of a well-defined accountability and reporting structure for the two other CROs

‣ A Global Communication Plan ‣ Global Study Metrics (to measure overall program progress) ‣ A Global Recruitment Plan ‣ Site-Specific Enrollment Plans

In addition to the leadership responsibilities, ACT assumed a portion of U.S. site management and clinical monitoring, as well as medical monitoring responsibilities for all European sites.

ACT Oncology Assumes Global Leadership

A CASE STUDY FOR: A LARGE BREAST CANCER STUDY

A C T O N C O L O G Y C O N T A C T I N F O R M A T I O N

W W W . A C T O N C O L O G Y. C O M

CHRIS ELLIS Senior Director of Business Development chris.ellis@ACToncology.com 917-940-6464

PAT TEREK Senior Director of Business Development pat.terek@ACToncology.com 650-868-1788

People. Passion. Performance.Working together to

advance treatments in oncology

Results:

Under the direction of the ACT Global Project Director, the team of CROs, along with the Sponsor, are working together as an integrated study team. The program is being successfully conducted in accordance with new Global Study Plans and Quality Metrics.

‣ The global quality metrics were developed and established across the program within 60 days of ACT’s award of the program

‣ ACT assumed management of: ‣ Global operations within 45 days of program award ‣ U.S. operations within 30 days of program award

ACT transitioned U.S. operations within 30 days and global operations and management within 45 days

A C T O N C O L O G Y C O N T A C T I N F O R M A T I O N

W W W . A C T O N C O L O G Y. C O M

CHRIS ELLIS Senior Director of Business Development chris.ellis@ACToncology.com 917-940-6464

PAT TEREK Senior Director of Business Development pat.terek@ACToncology.com 650-868-1788