Case Study

Safety Expertise Leads To FDA Approval For Customer Compound

Source: INC Research/inVentiv Health

The customer tasked INC Research/inVentiv Health with 10 studies spanning Phase I-III.

CHALLENGE
To provide excellent service admist a fluctuating client environment, frequent protocol changes and additions, and large number of SAEs.

APPROACH
The INC Research/inVentiv Health team, which had established an excellent relationship with the customer team from the start, worked proactively to manage the high-volume of SAEs, inconsistent data forms and changing deliverables. At the project’s peak, INC Research/inVentiv Health was managing a very high volume of SAEs – 730 (initial and follow-ups) per year. As the number of protocols expanded, the SAE volume increased as well as the deliverables for the project.