Case Study: Post-Marketing Commitment Study

Pharmaceutical companies are feeling the pressure of a new level of regulatory scrutiny surrounding post-marketing commitment studies. These increasingly complex and often unplanned studies put a strain on budgets and require a delicate balancing act between meeting regulatory requirements and minimizing expense.

One of our customers faced this dilemma when the FDA required it to conduct a post-marketing safety study for its newest drug — a broad-spectrum antibiotic for pneumonia and bronchitis. On top of stringent data requirements, the seasonal nature of the indication and patient availability added another challenge to meeting the three-year timeframe. With a substantial investment already on the line, the customer needed Quintiles to help navigate this unfamiliar territory. We combined ingenuity, insight and rigor to deliver high-quality data in a cost-efficient manner.

To recruit and retain enough patients for this large study, we put key strategies into action. We kept our investigators engaged and motivated with site-specific retention plans that included mid-study "Web rallies." Contingency plans ensured we could quickly identify and replace non-performing sites.

As practicing physicians, our investigators had higher priorities than the study — the care of their patients. To maintain site relationships and ensure data integrity, we enabled our investigators to collect rigorous data without overburdening them.

We simplified processes and streamlined site initiation with shorter case report forms and documentation to help doctors who didn't have the staff or the time for extensive paperwork. Web-based training and weekly check-in calls kept investigators consistent in their research.