Case Study

A Contingency Plan Leads To Timely First-Patient-In (FPI)

Source: PRA Health Sciences

A Phase IIa randomized double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of of Study Drug when given Methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) who have had an inadequate response to conventional disease-modifying anti-rheumatic drug therapy (DMARD).

After an impressive bid defense, a major PRA client awarded a rheumatoid arthritis study contract based on our strategy for achieving first-patient-in (FPI) by the end of the calendar year. PRA’s plan depended on a closely managed project with clear timelines and responsibilities, as well as selecting key sites that could support our goal.