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For each clinical trial, a clinical trial agreement and budget are negotiated between the investigator and the sponsoring company so that the costs of carrying out the trial are reimbursed.
Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.
For each clinical trial, a clinical trial agreement (CTA) and budget are negotiated between the investigator and the sponsoring company so that the costs of carrying out the trial are reimbursed. Don't blow the chance to get what you want by winging it.
Negotiation is a part of everyday life, especially in clinical trials. Many professionals and lawyers spend hours daily negotiating. However, few people have ever formally learned the strategies and techniques of effective negotiations, and even fewer still have mastered the guiding principals that permeate the entire negotiating process—negotiating strategically and not instinctively; importance of being prepared; protecting your reputation; and knowing that expertise comes from knowledge and practice.
Understanding negotiation strategies is one thing, but personalizing them so they work for you in various situations is another. Effective negotiations require that you understand how you personally come across and how you interact with others' negotiation styles. And you must learn when and where to open up with more information, in what situations to talk openly about your leverage, and where to simply hint at it. In order to be an effective and reputable negotiator it is essential that you learn how to apply the following negotiation tactics in various circumstances.
In this peer-reviewed article that appeared in Applied Clinical Trials in April, 2013, Jeff Parke, an Associate Site Start-Up Team Lead, Regulatory and Start-Up at Quintiles, shares his expertise and guides us through the 3 Ps of a personalized negotiation style.
Adequate preparation will not only make a difference, it will be the difference between success and failure. Negotiation research unmistakably demonstrates the concrete value of preparation. And yet this is the most universally ignored negotiating tool.
As a contract and budget negotiator, it is our required processes as well as our responsibility to comprehensively analyze every substantive element of a contract and engage in consistent due diligence to ensure that we do not miss a substantive point during the negotiations.
We should never short change the process element of the negotiations. To consistently get what we need in a negotiation, we must marry the substance to the process. Adequate preparation—on both substance and process—is essential to success.
Relying on your sterling and known reputation and its tenets is the best way to be ethical in your negotiations. Use negotiation tactics that are not morally objectionable to you, and don't bluff, mislead, be vague, or ambiguous in your statements.
By ensuring that you have sufficient factual information, you can provide sites with legal rationales for any objections to their requests. It's also helpful to not give into the difficulties of other people. If they are rude, do not respond in kind.
Always be professional and let the site know you are aware of and understand their frustrations.
Assess the short- and long-term impact of the negotiations. Ensure that you have a decent negotiation tactic in place, which will ultimately help you achieve your goals and help you achieve your required metrics.
Have a plan in place to deal with impasses. Know when to put aside contentious issues, and revisit it later, after you have gained momentum by agreeing on minor issues.
Know when to "move up the chain." Sometimes you might not have the authority to agree to certain terms. Thus, you must know when to properly escalate terms to your legal team. This is particularly effective in situations involving larger academic sites with seemingly inflexible policies. If you have to escalate a specific request to the sponsor or legal for review, you must obtain the justification/rationale behind the site's request.
Best practice is to get this in writing (for documentation purposes) and to obtain as much info as possible. Sometimes it is a good practice to ask for web links that can direct you to a website that lists a site's general policies regarding CTA/budget negotiations. This information gathering will streamline the negotiation process.
Always actively explore alternatives that will expedite your negotiations. Ensure that you have a fair and efficient way to resolve disputes in a timely manner. Always explore options. There are usually a number of workable solutions to the problematic issues that arise. Finding out what those solutions are may take a little work, and, even though a solution may be workable, it will not necessarily be palatable to everyone. Nevertheless, a good negotiator knows that once they get an understanding of the whys and wherefores of each party's "positions," more often than not, there will be several options for bridging the gap, solving the problem, or resolving the issue in an expeditious manner.
Good negotiators care about being "fair," but they are also assertive about their goals. They push the other party to find the best solutions, not just the simplest compromises.