To the Rescue … Quickly

The Principal Investigator (PI) for one of the sponsor’s studies was dissatisfied with the quality and professionalism of the monitoring work performed at the PI’s investigative site. As a result, the PI refused to sign off on the study results until the sponsor re-monitors the site. For the sponsor, The Practical Solutions Group, LLC’s client, this became a highly sensitive and time-critical issue because it impacted the sponsor’s ability to file an NDA. The sponsor contacted us on Thursday with a request to very quickly assemble a qualified and experienced monitoring team for re-monitoring the PI’s investigative site. Within one day, we put together a team of GCP professionals, headed by a former FDA inspector, which started its assessment at the investigative site the following Monday. We joined them on Wednesday to make sure that the monitoring activities would be completed by the end of the week.

Several potential FDA 483 issues were identified during the week-long re-monitoring effort. Given that these issues were discovered before the NDA submission, the sponsor and PI were left with enough time to make corrections prior to the FDA inspection. The sponsor and the PI were very appreciative of the timeliness of the re-monitoring effort, the thoroughness of the documentation review, and practicality of the recommendations that were provided with respect to addressing the outstanding items. The business and regulatory risk to our client was minimized, and the relationship with the PI was repaired. The Practical Solutions Group, LLC did it again … quickly.