Service Description

InVentiv Health (IH) was contracted for safety evaluation and reporting for a Phase 3/4 post-approval pediatric clinical trial in western Europe. They filled the medical monitor gap we had within our company at the time. And although not contracted, they provided free advice regarding regulatory issues with European pediatric clinical trials.

What Went Well

IH provided all medical monitoring services and safety reporting for a Phase 3/4 post-approval study. They evaluated SAEs (and AEs). They also contacted the study sites directly to complete the SAE reports and time sensitive reporting to the FDA. They participated in regular team calls/meetings and updated the clinical team on safety reporting on a monthly basis.

What Could Be Improved

I felt they did an exceptional job. From the bid defense, they provided information that we did not have ourselves. They gave us several issues to consider during the protocol review so we were able to incorporate their ideas before the study started. In addition, they provided publications, journal articles pertinent to our study and the issues we were dealing with at the time. My only complaint is that they are too expensive for the smaller companies to afford. I realize they are larger so their prices are higher, but they were exceptionally higher. There were compromises made so the prices were reduced for us, but they were still higher than other comparably large CROs.

Lessons Learned from the Experience

You get what you pay for. We paid a lot and we got a lot. I wish there was a way to get the same quality and attention at a lower price. I would be willing to expand our contract to other services, if we could afford them. We rationalized the cost for the medical monitoring because they had expertise we lacked and fit a perfect gap on a minimal basis. We were unable to rationalize expansion of the scope of their services due to lack of funds and we felt we could get similar quality at a lower prices from other CROs.