Service Description

This is a pivotal phase III study in head and neck cancer. Parexel was hired to evaluate and recruit study sites, oversee patient enrollment, manage and monitor study sites, collect and clean data, and analyze study data. This is a critical study for my company and expectations of Parexel are high.

What Went Well

There is not much I can say in terms of positive experience. In spite of best efforts to make expectations clear to Parexel, and having regular governance meetings with them to address issues, the overall experience is unacceptable. I'll provide details in the next section.

What Could Be Improved

This is a critical study for my company; its phase III and will reuslt in an NDA submission. Achievement of the patient enrollment timeline is critical, so not to delay the expected submission. We approed Parexel as a global provider about two years ago, and this was their first opportunity to take on an important study. Parexel assigned an appropriate number of team members and in the proper time frame, but the quality of the team members is unacceptable and there are persistent issues that it seems Parexel simply cannot fix. Deliverables are late and of unacceptable quality. The internal team has repeatedly worked with Parexel to help define the underlying issues, provide additional training, and provide feedback to the Parexel team. When issues did not improve, Parexel sr. managment was brought into the conversation and they agreed to assign new team members were needed. In spite of this, performance has not improved and the study timeline can now no longer be achieved. It would seem that Parexel does not have access to qualified resources, and as such, I would not consider working with them again.

Lessons Learned from the Experience

What I learned is that in spite of Parexel's promises and commitments, they could not deliver our study as promised and therefore have no credibility. We always have challenges with CROs, and sometimes we ourselves create some of the issues, but as long as issues are addressed and there's a successful outcome, I consider the relationship a success. Because Parexel is unable or perhaps unwilling to fix their issues, even with direct intervention by their senior managmeent, I can't support working with them again.