Service Description

CRL was contracted to evaluate standard cardiovascular parameters including various ECG intervals (e.g., PR, QRS, QT), blood pressure and heart rate in conscious telemetered dog after single oral administration of test article. The study was a Latin square design to evaluate the effects of different dose levels. Ultimately, the margin to a No Observable Adverse Effect Level (NOAEL) was determined. This study, performed to GLP standards, was used to support submission of an IMPD.

What Went Well

Preliminary cost assessment and detailed study plan were prepared in a timely manner to assist the sponsor in deciding if the design would provide needed information for the IMPD. CRL worked in a timely fashion to provide this information, perform the live phase, and deliver draft report. The data was high quality. They also worked efficiently with a secondary provider to ensure that TK samples were shipped appropriately for subsequent analysis. CRL ultimately worked closely with the sponsor to ensure that necessary discussion points were included in the final study report.

What Could Be Improved

CRL did what was expected for a standard delivery. However, results obtained after reading of the ECG waveforms showed a high degree of variability that raised a flag for the sponsor based on their own internal (prior) experience. The sponsor spent time with CRL scientists to ensure that the two individuals reading the ECG intervals were using the same criteria for, for example, the 'end of the T-wave' in order to appropriately assess possible iatrogenic changes. To their credit, CRL scientists increased their reading precision. It's unfortunate, however, that the sponsor had to train the staff in this process.

Lessons Learned from the Experience

CRL was originally selected as a 'preferred provider' because of multiple considerations, including relative cost of a study. However, we did not factor into the deal the need for expert training. Admittedly, CRL did deliver, finally, a high quality study that supported a submission and are now delivering on similar studies in a much more routine and quality level. From this, I've learned that the level of expertise required to perform this type of study should not be underestimated. In addition, higher associated prices may relate to internal expertise levels.