Towards the end of last year we got a call seeking urgent help with an investigational new drug (IND). The company which focuses on rare diseases needed to meet a very tight timeline of just a few days to complete the publishing of the submission and conduct quality control. Fast forward to the conclusion and, yes, the company got its submission completed on time with the highest level of quality.
By John Verrone, Global Head, Regulatory Publishing and Quality Control
That’s an all-too-familiar story for any pharma company. Products are years in R&D and clinical trials, but often the submission process is rushed, while at the same time the need for trusted quality control (QC) processes is critical. So let’s backtrack to where the story really begins.
What Defines Quality?
I believe it starts with an analysis of your partner. How do you evaluate a true business process services (BPS) partner, what are the things you need to look for, and what does quality mean?
BPS capabilities are about governance, process, checks and balances, training, and more. Turning to a partner to handle quality oversight is an exercise in trust in the level of expertise your partner has. You want to know that every aspect of the quality management is handled to the highest standards, and that your timelines can be met, no matter how tight.
True quality comes with proven outcomes over many years. It’s about processes, having the right tools in place, having program management expertise, demonstrating the right checks and balances, and above all having the best people for the job.
For example, our independent quality review team comprises a strong and experienced group of people who have a proven background in publishing before moving into quality. There are processes in place to ensure all deliverables are met and that all quality levels are achieved. That’s just one part of the collective skill set involved in meeting quality standards clients should expect.
Seeing the Big Picture
The bigger picture is about the full package that leads to the outcome. It’s a bit like a top golfer walking up to the ball before teeing off: It’s not just the way the player holds the club or stands over the ball or swings the club – it’s the full package that makes that person the best in their sport.
I believe the best way to define quality is with outcomes. We have an unprecedented regulatory publishing track record: more than 45,000 global submissions and not a single refusal to file.
Quality in Practice
If we return to our example – the IND that needed to be prepared for submission and QC’d in a few days – it’s clear just how much is involved and therefore just how important that experienced team is. With a support team in the United States and in Tianjin, China, stepping in, the workload was processed and completed in 72 hours. Steps included:
- Publishing of Protocol, Clinical Study Report, including external links to tables, figures and appendices
- Publishing of Non-Clinical Report
- Publishing of Module 1, Module 2 Summaries, and Module 3 CMC files
In total, we’re talking about 43 files, 2992 pages, 2383 links and 1605 bookmarks – all in three days!
These outcomes require that a BPS partner conducts constant evaluation of processes and work instructions, as well as analysis of where improvements need to be made. It’s about training teams to make sure everyone is on the same page, and always striving to do better.