Biopharmaceutical companies are facing significant cost pressure due to patent expirations and payer demand for lower drug prices. Better selection, planning and management of investigator sites and patients provides a great opportunity for generating cost efficiencies without compromising data quality. Combining data on historical site performance with current information on prescribing and/or patient demographics is critical to appropriately prioritizing potential investigator sites. Once selected, testing clinical trial participation messages with patients, supplementing site enrollment with performance-based patient recruitment strategies, and registering patients in a tracking service will also generate time and cost efficiencies through increased throughput with reduced burden at the site and fewer patients lost to follow-up. Outside of targeted site selection and supplemental patient enrollment/retention, an additional innovative, but proven strategy for generating efficiencies is to change from a purely on-site CRA model for site monitoring to a process that includes a blend of on-site and centralized monitoring activities.

• Discuss strategies for more targeted, cost-efficient, site selection and patient recruitment
• Describe a more targeted, cost-efficient approach to clinical trial monitoring that will not compromise data quality
• Present information on how patient registration with a third party can improve study efficiencies and potentially data quality