Service Description

Covance was contracted to help design, conduct and analyze a Heath economic observational research study for a recently approved injectable product. Our company does not have much in house expertise so we contracted with Covance who we thought had experience and expertise in conducting these trials. They were to help design the study including appropriate endpoint, and selection of PRO and data collection tools. There contract also included protocol writing, study conduct from site selection to database lock and data analysis. They are also contracted to assist in writing any publications from the trial

What Went Well

The CROs mid level people ( project management CRAs etc) are knowledgeable and responsive the study conduct went well. I feel that they kept me as a sponsor well informed of the progress and abreast of any possible foreseen stumbling blocks. They did well in suggesting possible solutions to potential problems.

What Could Be Improved

While Covance may have expertise in conducting economic observation trials I do not feel that they did a god job of learning the details of the actual product being studied and potential advantages / disadvantages Erasmus perceived competitors. Additionally I do not feel that they did a good job advising us as a new sponsor regarding the timing of conducting a trial such as this. If appears that for some products frequently used in manner different than the labeled directions ( for instance higher or lower doses or longer or shorter infusion times) it may be advantageous to allow practitioners to become familiar and comfortable with a new product before conducting an observational research study. Additionally I believe the contracting process was cumbersome and loaded with change orders. It seems like the initial proposal should provide an estimate for each line item but also allow for a certain percentage of overage with out requiring a change order.

Lessons Learned from the Experience

I learned that even though you have a good experience with one division or group in a CRO that same quality can not be assumed of other divisions. I also learned to very carefully look at all estimates for each line item in an agreement as any change will require a change order and all of the associated lost time. I feel the study conduct team did a good job of addressing challenges and providing solutions as problems arose but I do not feel that the protocol design team Dina very god job at all in respects to learning the unique economic factors associated with the product and designing the protocol accordingly.