Develop a Workable, Livable Quality System
Clinical research organizations that work with very vulnerable patient populations have to maintain the strictest confidentiality while ensuring FDA compliance and sponsor support.
For one CRO based in Califorinia, they originally hired us to perform a mock FDA audit and conduct cGCP training. As we got in, it became clear that a mock audit was not in their best interest. Instead, they really needed help designing a modern, simple quality system to allow a high degree of flexibility given their academic setting while giving them, their patients and sponsors, and the FDA, the level of confidence needed to achieve clinical data integrity and full patient safety.
Do you comply with confidence and flexibility? Or just overhead?
Our analysis helped the CRO management understand that although they were doing many of the right things – they weren’t documenting as they should, their lead investigator was on the verge of being too busy to actively oversee the trials, and that a clean, streamlined, simple-to-follow clinical quality management system needed to be developed.
First, we conducted two half-day workshops – one for their management team and one for their staff (including nurses and student assistants) – on today’s FDA expectations for clinical data and clinical quality controls. This wasn’t telling them how to their job, it was showing them what FDA looks for to verify that the CRO knows what it’s doing.
We outlined how FDA trains its clinical inspection teams, what an FDA inspection looks like, and how an inspection of their clinical organization will differ from the sponsor audits they had already been through. This ensured a solid grounding for everyone – true knowledge sharing – and gave everyone a real understanding for the clinical quality system framework that needed to be put into place, why, and how to keep the SOPs and policies flexible and low-cost while retaining effective compliance.
Then, we went through their controls – whether written or unwritten – reviewing documents, interviewing personnel, and uncovering the informal controls and unwritten processes that were helping the CRO succeed.
Finally, we provided our client a detailed blueprint, including prioritized implementation timelines (and the logic behind those priorities), as well as multiple example templates and SOPs. The goal was to ensure compliance while keeping their success going. We then continued to check in with them over the year to make sure their implementation was progressing and to head off any possible challenges before they could arise, a level of courtesy follow-up that is part of working with Cerulean.
Pleased, this is what they had to say (name withheld due to confidentiality):
“We used Cerulean because of their background experience, level of knowledge, and the different situations in which Cerulean had helped other clients.
John is an excellent listener and would give succinct and real answers, telling us of consequences that may occur, based on his experiences. John also linked the realities of inspections with a strategy for us to prioritize our way out. He is personable, humorous (which helps to break the tension), and very hard working.
If there is one word or phrase that describes Cerulean, it is “body of knowledge.”
– Chief Administrative Officer, Sacramento, California
If this sounds like the type of consultant you’d like to work with, or the type of success-oriented help you’d like, contact Cerulean today.