Ricerca's Personalized Approach Helps a Client Get FDA Approval of a Clinical Protocol

A biotech company wanted to expand the indications of a commercial IV drug. The clinical study was being scheduled when they learned that the FDA required an acute preclinical toxicity study of the new formulation and concentration before they could start. Our toxicologist worked with the client to quickly devise a study protocol. The client realized they had omitted to specify the need for a hematology requirement after the study had begun. Drawing on our experience and careful pre-planning for the study, we were able to accommodate this requirement immediately and salvage the study.

When the client wanted to take an unusual approach to the presentation of the data, we advised them of the accepted norms we had used over the decades of our toxicology experience. The client had the final report in less than half our normal turnaround time to present to the FDA and they got approval to start their clinical trials.

We were able to react quickly to our client's needs, advise them, and keep them on schedule because we provide direct study director involvement in the execution of all studies.