Are You Correctly Conducting Your CRO Qualification, Oversight, And Audits?

By Ed Miseta, Chief Editor, Clinical Leader

David Kim has spent most of his career working on clinical trials. His 17-year work history in pharma includes positions with Merck, Novartis, Schering-Plough, and Covance. His last position was with Samsung Biologics where he was responsible for business development for the Contract Manufacturing Operations Unit.  He has now returned back to the clinical world and currently helps life science companies with their studies as an executive consultant for Celeritas Solutions. His areas of expertise include implementing strategic alliances, leading and directing sourcing and vendor management teams, and partner negotiations.

In this interview with Clinical Leader, Kim discusses the challenges of CRO qualification, oversight, and audits, and how to make sure you are not being overcharged for the work you outsource.

Ed Miseta: How do you differentiate between CRO oversight, qualification, and audits?  

David Kim: That is a good distinction to make and I do encounter folks who are not clear on the difference. Oversight is the practice of ongoing performance management – in other words, performing assessments in real time and providing a holistic view of performance. This includes making sure the trial is on track and everything is running as planned. It is more of a paradigm or the model you use to ensure you are providing effective review and management of your vendor and your trials.

The audit is actually a component of that. In fact, it is the component that determines whether or not your CRO is doing what they're supposed to be doing. It also tends to look at very tangible items. Things such as whether or not proper reports are being filed and problems being reported within specified and agreed upon timeframes. It also looks at interactions with the sites. So, while oversight is more of a holistic perspective that looks at the methodology you will use from the beginning to end of your trial, an audit is looking at tangible and specific performance output.

Miseta: Where does qualification come into the picture?

Kim: I tell clients oversight and audits should also not be confused with qualification. Qualification looks at the activities that are going to be outsourced to see if you or your partner have subject matter experts in those areas, such as data management and computer systems, for example.  

The validation aspect of that includes reviewing SOPs, training guidelines, personnel records, and more. This is to ensure your CRO is able to handle the activity you are outsourcing to them in a standardized, repeatable, and effective manner.

Here is an easy way to keep it all straight: If you consider oversight to be the hub of a wheel, then qualification, ongoing audits, governance meetings, metrics, and day-to-day communications would be the spokes of that wheel.

Miseta: You spend a lot of time working with small- to mid-sized pharma companies. Are there some common problems that you see many companies struggling to overcome?  

Kim: Selecting the right CRO is certainly an issue that comes up often. Preparing a good CRO performance scorecard and knowing how to perform a proper audit are also important. And certainly understanding what you are being charged for, and whether or not those charges make sense, is something all clinical executives struggle to understand.

Miseta: I have spoken to many clinical executives who have concerns about pricing and whether or not they are being charged the right amount for the work being outsourced.  And yet, it’s not a topic you often hear discussed at conferences. Is there anywhere these professionals can go to review reference pricing and know they are not being overcharged?

Kim: That is actually something we are developing right now for one of our midsized clients. We are looking to develop and establish a benchmarking tool that will look at the industry averages. We are looking at it from a unit price perspective, trying to break expenses down into unit costs based upon parameters of the study and also as a percentage of the overall aggregate cost.

Those parameters might include things like number of patients, number of sites, and number of countries. By unitizing the costs, companies will be better able to compare apples to apples. When an RFP is received from a provider, costs can be scrutinized, even when items are bucketed in a slightly different manner.

Smaller companies do not have a lot of personnel or infrastructure in place. Understanding the RFPs and pricing mechanisms requires an understanding of the study, finance from a clinical perspective, and a lot of finessing. Even benchmarking your own previous studies can require a lot of effort.

Miseta: I have to think CROs are also paying close attention to what the market is telling them in terms of pricing.

Kim: Oh, absolutely. And they are doing this every time they lose a bid. CROs can be a pretty pensive group. Every time they lose an opportunity they will adjust or fine tune their bidding based on feedback received regarding their pricing among other factors. They are constantly fine tuning their bids based on what they believe the market rate to be.

I also recommend using your own bid grid. Don’t send out your specs and wait for the vendors to supply theirs. That makes it very hard to compare. Providing your own bid grid allows you to control how the pricing model is going to work. It also gives you a real-time indication of what the market pricing is at that moment. From there you can compare to see what you are paying for.

Miseta: You will be one of our featured speakers at Clinical Leader Forum in May. What do you hope to get out of it?

Kim: Networking is always a primary goal for me. Being away from the clinical arena for the past two years, it will be nice to make some new connections and hear what companies are currently doing to achieve success in their trials.  

At times it can also be difficult to fully understand the level of frustration executives can feel when dealing with challenges such as choosing a CRO, getting bids, pricing a study, managing your partners, and providing oversight. These are areas where we can all learn from each other and improve and enhance the existing models we use.

Clinical Leader Forum 2017 is a different type of conference. The focus is on issues and challenges important to you, actionable information you can immediately put to use improving your trials, and knowledgeable presenters who have faced similar challenges and overcome them. For more information or to register, please go to www.clinicalleaderforum.com.