Service Description

Haematology analysis of whole blood cell, and more specific ANC calculation

What Went Well

The CRO suggested to add blood films prepared at site in case the wet sample was compromised. The site would use the blood film to assss if the total WBC was really low (due to chemotherapy treatment) or due to sample handling and the sample was compromised.

What Could Be Improved

The CRO was not proactive when a very cold weather spell which affected the samples (clotting, haemolysis) and samples were lost due to the late awaking of the lab technicians, QC and speially PM oversight of results. It was expected (inlcuded in the contract) the PM to review the results on a routine manner to spot such increases on samples unable to be analysed or results cancelled due to poor handling of the sample, process which did not occur.

Lessons Learned from the Experience

The first lesson was to ensure that PM at the CRO has an understanding of the lab result and the impact on the study being haemotolgy parameters primary end points. Although a well experience lab in clinical trials, no "outside the box thinking" and lack of proactivity (the sponsor was the one who raised the flag of something was wrong), did affect the normal run of the study and its analysis. Lessons learnd - a continuous and close oversight of sponsor to lab performance, especially in exeptional circumstances of weather or transportation issues (airlines/airport strikes).