Service Description

Covance was contracted to receive, process, and report results for all lab samples from 25 sites in the US, Canada. The central lab sample panel included Chem, Urinalysis, anticoag, INR, etc. We did not ask them to receive or process any usual samples. We requested the local labs to receive and process ammonia samples, however, we did not ask Covance to do the same because the ammonia samples need to be analyzed quickly. Covance was asked to do what they do best - central lab sample handling, processing, result reporting (via fax + website).

What Went Well

We amended the protocol several times to extend the length of the study. Covance did not handle amendments well. Samples were being collected every 6 months and the lab panel did not change, so the amendment was fairly straight forward. They were unable to accurately calculate the additional samples with each amendment. I corrected the numbers with each revision. In addition, it took a long time (3-4 months) to get the amendment approved, quoted, and signed with Covance. We are not a big company and the amount of money (although large to us) was not large to them. Their delays and slow processing (and inaccuracies in the budget and sample projections) made us feel like we were not important and that their time and efforts were spent on larger clients. I tried to build a relationship with the project manager via phone, regular meetings, etc. and although we had a good working relationship, I was unable to get the Covance team to move faster or produce accurate budget, contract paperwork. I have worked with Covance on Phase I studies, and they performed much better. I will likely work with them on future Phase 1 studies, but not central labs.

What Could Be Improved

Covance could have been more responsive to our amendment requests and processed the amendment faster. We simply extended the study to include additional visits, but did not change the central lab panel, sites, etc. In my opinion, the changes were simple, minimal, but Covance took 3-4 months to process the requests. Also, despite walking the project manager through the changes verbally and over email, the paperwork was not processed correctly. After walking through the mistakes, they did not correct them. It was a painful process.

Lessons Learned from the Experience

Covance did not think outside the box. They couldn't think within the box, let alone out of it. I had a frustrating experience each time we amended the protocol. I will not likely work with Covance again. I brought them into team meetings from the beginning, spoke with them individually via phone and email. I also asked them if they had suggestions so we could improve the relationship and communications, but the were mostly silent. I think the lesson I learned would have been to change project managers rather than trying to stick it out with the assigned PM.