Medical Devices

How to Effectively Manage CROs

Medical Devices

10:00, December 29 2017

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John R. Schultz, JRS Clinical Consulting, LLC, examines ways sponsors can effectively monitor CROs, in the effort to ensure the study reaches a successful conclusion

I’ve generally had very strong relationships with contract research organizations (CROs), but when I started to write this article, it was the first time that I really begun thinking about why those relationships have been strong. And when I did think about it analytically, I realized that one of the main reasons is that I never really treat CROs like a CRO. From the first conversation that I have with them, I do not think in terms of hiring a company to perform a function, I think in terms of mass-hiring new employees. Once contracted, they instantly become part of my team – part of my work family. That makes a big difference in how the CRO responds to the company, but there are also those that attempt to take advantage of that good nature. Regardless of how your CRO responds to your particular management style, they should be treated like any member of your work family. If they deliver, they should be rewarded and if they fail to deliver … well, that is where you earn your paycheck in managing a CRO.

Leadership is Influence

While the title of this article includes the word “management,” one key element to an effective relationship with a CRO is understanding the difference between management and leadership.  Leadership guru John Maxwell states in his book, The 21 Irrefutable Laws of Leadership, that leadership is influence. But as simple as that concept is, leadership and management are frequently confused as being the same thing. Understanding the difference between the two is not obvious for many of us, which may explain why there are far fewer leaders than there are managers. To greatly paraphrase Maxwell, management is taking care of the day-to-day logistics of the project while leadership is influencing others toward a shared goal.

Management consists of things like coordinating schedules, developing budgets, assigning tasks, etc. while leadership involves creating an environment that makes people want to strive for a successful study. It’s the difference between a team focused on completing their daily to-do list and one that consistently goes the extra mile so they don’t let down the team. Both management and leadership are critically important in engaging with a CRO but as you can imagine, one is more difficult to achieve. The day-to-day activities need to be managed effectively and that alone may get your project completed eventually. But just like any other member of your team, CROs require leadership in addition to management to be truly effective. The good news is that Maxwell says anyone can become a leader at any point of their career with a little work.

Lessons Learned the Hard Way

Early in my career, I was hired to manage a project and inherited a CRO that was well-established, academically rooted, and very well-respected with dozens of successful studies to their credit in this particular field. I thought my role was easy. Because they were such experts, I could simply give them a copy of the protocol, point them in the right direction, and let them do their thing. After a while, I realized that the direction of the study was not in the best interest of the company and the CRO was actually managing me! I was not leading. I was not influencing anyone. Eventually, the study failed – for a number of reasons but I learned the hard way. Even though the management of the day-to-day aspects of the trial was impeccable, that does not always lead to success. There was no ill-intention, negligence, or incompetence on anyone’s part but in this case, there was a lack of leadership on my part. The relationship with the CRO was very cordial, but they were doing what they thought needed to be done, not what their client required of them.

So, I learned that a CRO will always have some level of ignorance about your project and/or product. It is not the responsibility of a CRO to understand all nuances of your product or your market. Because of this, the CRO can miss subtleties that can sway success one way or the other. In this case, “success” means everything from site relationship success to monitoring report success to project success. Little successes build into study success. Think about the little victories you can claim and reward along the way to overall success. These are important – especially for those years-long trials. And this is where leadership comes into play. It’s vital to understand the nuances of key elements that can impact the long-term project success of your study.  Recognizing these nuances and acting on them at key moments can have a profound impact not only on the success of your project, but the potential long-term partnership with your CRO. To be successful, someone must own that responsibility. Relying on your CRO to do that is unfair to your CRO and it is also doing a disservice to your company. You must own the success of your project.  You must understand and act upon those nuances.

The Pathway to a Successful Relationship

So where do we find these subtleties? There are many along the pathway of your CRO relationship and I highlight a few here:

Before you choose a CRO, determine what you need and sometimes more importantly, what you don’t need from your CRO. Provide a complete but concise list of tasks and parameters to your candidates and provide exactly the same information to each CRO making a bid. Pay attention to the details of proposals. There is key information in proposals that can tell you a lot about the personality and philosophies of their company. The cost is only one element. Pay attention to the organization of the proposal. Does it tell a story about how they will help you achieve your goals? Is their approach in line with yours? Do they have an organization that is in-line with or complementary to yours? You are not choosing a machine, you are choosing a partner and a very important one. Make sure it is a fit in all aspects before signing that agreement.

Determine whose procedures you will use throughout the project and make sure both parties know them and are formally trained on them. This sounds like a no-brainer, but do not just blindly agree to use a CRO’s SOPs without knowing something about them. You need to know what you are agreeing to abide by during your study. Conversely, if the CRO is using your SOPs, then make sure every member of the CRO team is trained on them and that the training is documented. If you do not pay attention to this at the beginning of the project, you certainly will after an audit!

Details of the agreement and work order are not just a formality. Ensure all aspects of these documents accurately reflect what the CRO will do and how they will do it. Think in terms of enforcement of various aspects of the project, but also think about what happens if things go south. The agreement is your only relief, so make sure both you and your legal counsel are involved in this process.

Regular Meetings the Key to Building a Cohesive Team

I strongly recommend regular meetings – preferably weekly calls or online meetings. Some managers disagree with me on this and that is certainly their prerogative but in my experience, regular meetings are the simplest and easiest tool to use in building a cohesive team. Conversely, nothing kills a sense of team more quickly than a lack of communication. Even if they are five minutes long, a regular meeting gives both parties an excuse to bring up topics. Making them fun rather than tense loosens people up to share more and creates a team environment that engenders trust so that every member of the group feels personal responsibility to the rest of the team.

Read all reports immediately. Do not let them accumulate in a “to-do” pile that you’ll read when you get time like I did on one project. There are invaluable nuggets of progress and pitfalls in each report and if you do not act on them quickly, then bad habits can form and take hold because they are not corrected quickly.

Don’t just manage from your desk – get involved. Poll, or better yet visit, your sites regularly to find out what they like and what they don’t like about your CRO. Ask dumb questions – don’t assume you know everything because you’re a manager. Do ride-along visits with monitors. Participate in database user testing so you know what your sites are dealing with during the study. Nothing is more frustrating for the site than complaining to someone who doesn’t understand their problem.

Pay attention to subtle signs of behavior during the study. Are help desk personnel professional? Are there personality issues within the team or with site personnel? Are there inappropriate romantic entanglements – real or perceived (don’t laugh – this happens more frequently than you might think)? Don’t ignore these issues. Deal with them before the site calls to complain or to request new personnel.

And finally, once you bring a CRO onto your team, it is important to think of them just like the other members of your team rather than a hired gun. Get to know the individuals, including their strengths and weaknesses. Utilize their expertise. Get their opinion on how to handle situations within their purview but do not assume they know everything they need to know about your project. Educate them on your expertise and bring them into your fold. Make sure you are influencing your CRO – make sure you are leading them in addition to managing them.

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