Case Study

Safety Expertise Leads To FDA Approval For Customer Compound

Source: inVentiv Health

The customer tasked 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 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, 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.