She did a fantastic job in first of all identifying the key issues in the audits themselves and then at this visit interviewing the staff to prepare them for an FDA audit. This is a really important relationship and was always going to be a delicate balance of how we work with this site as they were the academic sponsor before it was transitioned to us, so it certainly wasn’t set up in the same way you’d expect for an industry standard study.
Her demeanour with them, her knowledge and vast experience has perfectly hit the mark at each visit and the site staff themselves have reciprocated in being very open to learning. In the close up meeting, both PIs from the studies spontaneously thanked her for her help and listed a number of specific examples of how she has done this. Due to her friendly, open, informative and coaching approach the site staff actually seem to have enjoyed this experience, despite them feeling quite anxious at the beginning of the process. I just wanted to acknowledge her great work here and we’re really pleased that she’ll also be auditing our UK site in the same way.