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41 JANUARY 2015 LIFESCIENCELEADER.COM Customized training at your facility: less money, more impact. Recent analysis of FDA 483s has shown that almost every observation has a training component. While ongoing training is critical, identifying and qualifying the right personnel to develop and deliver training is a time-consuming task. Benef ts of Life Science Training Institute's customized programs include: Actionable, practical instruction for life science professionals info@lifesciencetraininginstitute.com | 215-675-1800 - Online, in-person, and blended format courses designed for adult learners - Subject matter experts with a deep understanding of a wide range of topics - Fully customizable courses that will save you hundreds on per-attendee training fees therefore only pursuing additional metrics if we felt it was absolutely necessary. When considering the metrics which may be influenced by forces beyond a vendor's direct control, we were careful to allow "carve outs," which included "acts of god," natural catastrophes, and unforeseen regulatory authority changes. Aside from these common objections, both parties acknowledged that the goal of the quality agreement metrics is to help assess whether or not there is a pattern across all of our studies that can be learned from and applied to ongoing and new studies, in order to avoid a repeat of common sponsor/vendor grievances. CREATING A WIN-WIN SITUATION Critical to negotiation success and imple- mentation of the quality agreement and metrics was the participation of senior management from each company and their respective clinical and quality teams. This was important because it identified what each party thought was important in conducting a quality trial. Another example of how our qual- ity agreement negotiations facilitated collaboration was our discussion with a CRO around the commitment to have, at a minimum, a quarterly risk management meeting to identify risks and set up miti- gation plans. In this discussion, we were able to introduce the CRO to the usage of the failure mode and effects analysis (FMEA) tool in risk management for our studies. Both parties committed to setting up a process to manage risk in the quality agreement, where the specific details were to be discussed in future meetings. Two common objections raised by ven- dors during the negotiations of the metrics included how sponsors perceived that the required resources to collect and manage the metrics may deter from vendor's actual performance of their study-related tasks and how certain metrics may be impacted by forces outside of vendor's control. In the first instance, we made an effort when negotiating the metrics to continually assess what metrics the clinical service provider typically collects, The collaborative approach of establish- ing a quality agreement creates a sense of ownership of the project by all parties involved, with the common goal of con- ducting a quality study. This will ensure a "win-win" situation where both parties are committed to meeting their respon- sibilities without finger pointing and the focusing of one-way faults on the vendor for not meeting sponsor standards. As a result of the implementation of a quality agreement, a sponsor has a study that meets its expectations, and the vendor has gained the trust of the sponsor, hopefully leading to more successful future collabo- rations. L Jonathan Lee is VP of development operations at Cerexa. Mary Chow is director of contracts management at Cerexa.