10 Steps to Clinical Study Start Up: Step 7 – Negotiating the CTA

Partnerships In Clinical Trials 2011 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event.

10 Steps to Clinical Study Start Up: Step 7 – Negotiating the CTA

This is the seventh installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

Introduction

It is rare these days, for an original CTA template to be accepted, verbatim, by sites when they receive the first draft from the sponsor. This, in and of itself, is not a bad thing – quite the contrary: negotiation is a good thing, and when done properly the process should serve to meet the needs of all parties.

There are a multitude of complex and distinctly separate issues that arise when negotiating CTAs (e.g. indemnification, insurance, IP and publication rights, payment terms, etc.) and each of these topics merit their own discussion. Because of this, the scope of this article will cover the general concept of negotiation and not any specific clause or section of the CTA.

Preliminary actions to consider when approaching CTA negotiation include:

• *Need identification
• *Objective identification
• *Scope of the problem

Speaking from Experience…

Dan Manak has negotiated over 1,000 CTAs and can count on one hand the number of instances in which mutually agreeable terms eluded him. In no instance did any of these agreements undergo legal challenge or law suits. In most cases, when it appears there is no middle ground it is because one or more parties either do not know their limitations or they do not accurately convey them up front. If you reach an apparent dead-end, do not give up hope before escalating as much as you need to with the parties with whom you are negotiating.

Often times, the sponsor or CRO person with whom a site is initially negotiating can only do so much in terms of altering their standard agreement. This does not mean that alternative terms are unavailable, but it may require more leg work to get to the right people that can help find that middle ground. Whether or not escalation is called for, never lose your poise or professionalism, or let the negotiation turn into an argument. Keep in mind that you would not be in negotiations in the first place if all parties did not want the same thing – a fully executed agreement outlining mutual involvement in the trial.

Helpful Tips

Part of the planning and preparing process is to define and rank priority interests. The key here is to understand that these negotiations are based on different interests of the different parties and the likely result will be concessions regarding these interests. Make certain that you are trading items or issues of less importance in order to gain substance of greater importance.

Access the priorities of the other parties. The better you understand the other perspectives, the greater likelihood of successful outcomes through negotiation. This may involve some guess work on your part; hopefully they are educated guesses. This exercise alone will foster thought and ideas regarding conflict resolution. As we don the shoes of the people across the negotiating table, our minds will begin to creatively think of possible solutions, while considering the other party’s respective positions.

If you are a site and have had to pass on multiple contracts due to a single internal policy, it may be a good idea to have a full review of that policy. For example, Dan has worked with sites that had such stringent insurance requirements they were precluded from most trials. The solution may be to find an alternate provider. When it comes to payment terms and monetary reimbursement – if suitable terms are not met; the best choice may be to walk away, rather than accept a contract which would be financially unreasonable for your site to perform. A win-win scenario is what everyone is shooting for and there is no ‘win’ if your site will lose money to perform a trial. Always make sure you are well-educated on the subject matter, persistent in your follow up, and courteous and professional in every respect.

In Closing…

“We cannot negotiate with those who say, “What’s mine is mine and what’s yours is negotiable.””… “Let us never negotiate out of fear. But, let us never fear to negotiate.” -JFK Allan Valmonte is a Senior Director of Business Development at goBalto and has over 12 years of biopharmaceutical drug development experience. He served as a clinical research consultant for KAI Pharmaceuticals and StemCells, Inc., and held positions in clinical research and development at OXiGENE, Cerexa, and Telik. He has also worked on early, late, and post-approval programs for Integrilin® (Millennium), Vectibix® (Amgen), Lipitor® (Pfizer), and Xolair® (Genentech). Allan holds a B.A. in psychology from California State University, Hayward. Erik Sam is the Senior Director of Customer Development at goBalto and began his career as an engineer in the Process Research and Development department at Genentech, Inc. There he developed and optimized manufacturing processes in Late Stage Purification for numerous products entering clinical trials. He also ran successful GMP campaigns and collaborations with outside vendors to develop new technologies for the entire biotech industry. Erik holds a B.S. in chemical engineering, with a focus in biotechnology, from the University of California, Berkeley. Dan Manak is a Senior Director of Business Development at goBalto and a graduate of the University of Wisconsin – Madison. After earning his bachelor of science degree in Molecular Biology he began his career in pharmaceuticals with Hoffman-La Roche, holding positions in sales, sales management, and training. He has worked in pharmaceuticals, health care, and clinical research for over 20 years with Fortune 100 companies as well as start-ups. For the past seven years he led a small clinical research service organization as the President and Director of Business Development. His expertise and passion exist specifically in the area of clinical study start-up, having worked on several hundred protocols and initiating close to a thousand investigative research sites. In his spare time, Dan is a volunteer EMT and martial artist/Instructor.

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com