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CMO 2015

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 32 By E. Miseta BEST PRACTICES FOR ESTABLISHING AND MANAGING A BALANCED QUALITY AGREEMENT QUALITY AGREEMENTS outsourcing ommended that the quality agreement always specify who will notify the client of deviations. It is best for that person to be someone on the quality team and not the project manager. If we have a relation- ship where CEOs are talking to CEOs and project managers are talking to project managers, then we should have the qual- ity people interacting with each other on issues of quality. IS IT IN THE REG? The panel covered two additional points that are worthy of consideration. The first is, don't be afraid to relent on an issue, especially when it involves inter- nal procedures or actions not mandated by regulatory requirements. "We were well into a project when we encoun- tered an issue," notes one panelist. "It was not addressed in the quality agree- ment, and it wasn't in the Master Service Agreement (MSA). It was an issue where the two sides just had opposing views on it. We ultimately conceded, but a situa- tion like that happens a small percent- age of the time." Another panelist discussed a situa- tion where a CMO pushed back and said, "Show me the reg." Upon looking into it, he discovered the reg didn't actually say what he thought it did. The company had simply been doing it that way for years. " We don't even know who it was, 20 years ago, that said we should do that," he said. "Eventually we relented." The lesson learned? Be will- ing to work with your CMO on quality disputes, especially if a regulation is not there to back it up. In closing, I think one final point should be made. A quality agreement, once signed, is not etched in stone. There is nothing that says it can't be changed as needed. Quality personnel from both sides should be open to amending, adding to, or deleting from the agree- ment as the project, the relationship, or applicable regulations change. Always remember your CMO is your partner, and you need to be able to work together to ensure both sides are successful. L its quality agreement actually makes a lot of sense. CMOs have signed hun- dreds, if not thousands, of agreements with sponsor companies. It is unlikely an issue would arise that they have not already considered and made accom- modations for. The bigger issue might be forcing the CMO to abide by different rules for dif- ferent clients. If that CMO is working with 30 sponsors, and 29 require a devia- tion notification within 48 hours, then a client requiring a 24-hour notification of that same deviation throws a wrench into the works. There also can be differ- ences in how a client is notified (i.e., by phone or email). Someone in the facility would have to remember or somehow keep track of all these caveats. In that type of situation it is better for the client to look at their agreement and ask if they really need to be notified in 24 hours or if they can abide by the rules the CMO already has in place. WHEN SHOULD WE DISCUSS? If you are in discussions with a CMO, when is the best time to discuss qual- ity agreements? Should it be when you are vetting the company or after you have made your selection? Perhaps at the same time you submit an RFP? One school of thought is to negotiate the agreement in parallel with any kind of service agreement. However, that may depend on the type of relationship estab- lished (transactional versus strategic partnership). Quality agreements should also reduce subjectivity as much as possible, sim- ply to reduce confusion on both sides. For example, don't try to differentiate between a minor deviation and a major deviation. That is too subjective and will drive people crazy. Simply note that all deviations should be reported within 24 hours. Unfortunately, sometimes the CMO relationship is managed by someone who is not a part of the quality team. That can add another layer of complexity to the notification process. One panelist rec- template is easy to navigate and under- stand. Vendors and clients can generally get through an agreement like that in less than an hour. However, use caution when using one of these to avoid a lack of specificity. If a task is assigned joint responsibility, it can be easy for both sides to overlook it. For that reason, it may be best to avoid joint responsibil- ity situations or to clarify where one responsibility ends and the next begins. One of the toughest situations for a CMO is when a client comes in and insists on using their own quality agree- ment. If a CMO is working with 40 or 50 clients, there could potentially be 40 or 50 different agreements they must work with each year. A sponsor's attor- neys might insist that vendors use that specific agreement, but it will take lon- ger for the CMO to figure out what it is agreeing to. While newer companies (e.g., a small start-up bio firm) might be reluctant to accept a CMO's quality, starting with One of the toughest situations for a CMO is when a client comes in and insists on using their own quality agreement.

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