Service Description

Covance didn't do a good job for this trial. First they sent a wrong sample kits. Second, for sample bioanalysis, they didn't told us that the samples were severely hemolyzed until almost the end of the trial. Further investigation found that their employees were not properly trained to handle the clinical samples. There are some small issues happened during this study. for an international company, i would expect i got a high quality data from them which unfortunately it is not. what we learned from this, regardless of which CRO you use, close monitoring is a must have

What Went Well

Covance can set up these studies quickly and can provide the itemized cost in details. The sample logistics is good. However, their PIs should have more experience and training. Hemolysis is a not very difficult issue to find. Their non finding until late stage of the trial is really difficult to understand. As i said before, for all study conducted in CRO, there is no worry free studies.

What Could Be Improved

Several things comes into my mind. The PI and other employees need more training. Also the Central lab staffs should also warned us earlier so we can remedy this undesirable situation. after this incidence, Covance re-issued the SOP and re-trained all employees. this is plus from this incident. hopefully no other incidents happen again.

Lessons Learned from the Experience

Covance did not think 'outside of the box'. Instead, they tried to push the responsibility to the clinical trial site. it is not very responsive to our initial questions and requests. we didn't get the answers until the involvement of senior management. i don't whether we will use Covance any more. but, as i said before, close monitoring is necessary when outsourcing