University-based CRO expanding into commercial clinical trials
A quality management system for a CRO — university-based, expanding into commercial trials
The challenge, in operational terms
An investigator-led CRO based at a university was expanding its clinical trial services to take on commercial sponsors, and wanted to offer full trial management. The scientific and technical expertise was already there. The quality systems expertise wasn't, and an independent gap assessment had identified several major gaps they needed to close.
What I did, including the assessment method
I interviewed staff to understand how the business actually ran and what internal resource they had, reviewed the existing gap assessment, and mapped the key processes. Then coaching and brainstorming sessions with key staff, using the process maps to work through solutions together, before drafting SOPs based on what came out of those sessions and what compliance required.
The result
They ended up with a quality management system suited to the services they were actually offering, the existing gap assessment used to close out the major findings rather than repeated, and clear roles and responsibilities that let them plan recruitment and write job descriptions.
Related services
Design & Implementation of Tailored Quality Systems
Building a quality system for a company moving into regulated manufacturing, or fixing one that's stopped working. Sized for where you actually are, and built to grow rather than be replaced.
For: companies with no system, or with one that's become unusable.
Who you'd be working with.
I'm Antiksha Joshi. I've spent 28 years in pharmaceutical and life sciences quality across three continents. I am Chair of Women in Pharma, ISPE Australasia Affiliate.
I also write and speak on quality systems for various knowledge sharing organisations and online publications.
My background is in microbiology, and I hold a diploma in counselling, which sounds like an odd combination until you've watched a technically sound quality system fail because nobody could be persuaded to use it.
Whoever you speak to on the call is the person who does the work.
