Service Description

inVentiv interacted with Health Canada for a Phase I healthy subject study. We worked with the inVentiv team to design the study, calculate the power level, interact during an FDA meeting, conduct the study, analyze the samples, and eventually write the clinical study protocol. The study is ongoing.

What Went Well

The project management staff and sales team at inVentiv were very helpful with coordinating communications with Health Canada. The recruitment of volunteers was very efficient and the study started on time without any problems. The inVentiv staff worked like a well oiled machine during study conduct and was able to reduce a couple weeks off the timeline by efficiently planning the study conduct.

What Could Be Improved

So far there have not been any challenges with the study. No suggestions for improvement.

Lessons Learned from the Experience

The sales Director immediately connected us with the Project Manager that would handle our project during the initial discussions. We were also able to increase the speed of the study by separating our study setup costs with the main study cost. We negotiated a tiered bracket cost structure to conduct additional studies. The inVentiv staff are always available to discuss the study or answer questions anytime.