Nonclinical Outsourcing: The Importance of Revisiting Perceptions

Earlier in my consulting career, I wrote articles that were published in the trade magazine, Contract Pharma. You can still find many of my articles in their online archive at www.contractpharma.com. Back in 2007, I wrote an article about how perceptions impact our business decisions. You can read that article via this link: https://www.contractpharma.com/issues/2007-06/view_preclinical-outsourcing/perceptions/53465.

Perceptions are powerful business drivers in nonclinical outsourcing particularly in the area of CRO performance. Perceptions about CRO performance can be so favorable that sponsors can be blind to real or potential operational risks. Conversely, perceptions of CRO performance can be so poor that sponsors may never consider using a particular CRO. I am aware of a pharmaceutical company that won't consider placing work at a particular CRO site based on concerns that occurred over 25 years ago. As an independent consultant, I often hear about perceptions of CRO performance from sponsors and other consultants. I also form my own perceptions based on my direct interactions with CROs.

The problem with perceptions is that they become dated and, if you haven't done your CRO due diligence, you could be making critical business decisions based on inaccurate information. Over the past year, I've discussed nonclinical CRO performance with numerous sponsors and consultants. It is easy to understand that someone may not want to place work at a CRO if they encountered a bad experience there. The problem is that these stories tend to take on a life of their own. Some actually become industry folklore. It is common to hear about CRO operational concerns but when you ask for further details, you learn that either the issue occurred years ago or that it was a story that has been shared so many times that no one actually knows the exact details. The perception is embraced but the current status is ignored.

Consider the "story" about what today is the Covance CRO facility in Greenfield, Indiana. For years, this was the site of Lilly's toxicology operations until Covance purchased it in 2008. Several years prior to the purchase, Lilly had shifted the operations from GLP to non-GLP. There is a difference between the organizational mindset of pharmaceutical research operations and CRO operations. CRO operations move much faster. You just can't change the company name and have the operations immediately function like a CRO. Those who follow the industry understand that the Lilly-Covance transition was challenging and some clients encountered quality issues. To this day, I am periodically reminded of quality issues that others experienced years ago. However, that isn't the end of the Greenfield "story". As in any business, people come and people go. The operational leadership and technical staffs at Covance-Greenfield have changed over the years. Those who are experienced in operations understand that it can take many years to assemble an effective research organization. To this day, many in the industry don't realize that Covance-Greenfield started conducting GLP operations in 2016. Even since then, additional experienced, operational leaders and scientists have been added. The operations at Greenfield today have matured to the point that sponsors from large pharma to biotech routinely place work there. Business at the site is robust. The Greenfield site has emerged as a viable alternative to Covance's Madison, Wisconsin facility primarily because there has been extensive procedural harmonization and operational leadership sharing which is something that you don't always see at multi-site CROs. It's a nice operational story but, unfortunately, the current day facts can still compete with the perceptions that were born in the past.

Every CRO has an operational "story". Some are good and some are bad. While it is advisable to check with industry colleagues regarding their own experiences with CROs, it is equally important for sponsors and consultants to conduct their own due diligence. Sponsors spend millions developing drugs so it is best that the CRO selection process be based on more than hearsay information...you want to make sure you have the right "story".

Finally, for those on the CRO side of nonclinical outsourcing, you are more likely to build business relationships based on trust when you proactively share operational information. Even if your CRO is facing operational challenges, having open discussions about them is best. Sponsors and consultants can be quite understanding and even contribute to potential solutions when they aren't surprised by operational issues that should have been shared with them in the first place. Transparency and openness kills unwanted perceptions.

Author's Note: The idea to write this article was my own. I have a pet peeve when I encounter misinformation so I felt it was appropriate to share my thoughts about the Covance-Greenfield site. No one told me what to write and no one reviewed the content of this post (so any grammar errors are my fault). If you check out my profile on LinkedIn, you'll note that I describe myself as an "independent consultant". I place a heavy emphasis on being independent.

In the interest of transparency, I managed the general toxicology component for Lilly at Greenfield from 1995 until 2002. During my consulting career, many CROs in North America have engaged me to provide operational assessments. I provide feedback on client expectations; organizational effectiveness; regulatory compliance; facilities; and operational capabilities. In 2017, I was engaged by Covance to assess the toxicology operations at Greenfield. From 2018 through 2019, Covance engaged me to periodically assess and critique the toxicology operations at Greenfield to seek opportunities for operational improvements. So, yes, a CRO hired me to critique its own operations. That took courage. However, the real story is that I only provided opinions. The operations team did all of the work and, frankly, they came up with many additional ideas. Finally, in the interest of additional transparency, all of my other clients were always informed that I was providing a consulting service for Covance.