Life Science Leader Magazine Supplements

CRO Supplement 2015

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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31 LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2015 What if we only hired diabetics to work in the active cold chain? Would they take more care handling healthcare products? We think they would. They know what happens if they don't get insulin. Of course we don't just employ diabetics. But we do share their understanding of the value of what we ship in our containers. We educate the members of the active cold-chain on the difference they make to the lives of diabetics and others who rely on healthcare products. Because people do a better job when they understand the importance of why they are doing it. Gunay Hadjimehmed is a diabetic. And his son Mehmet works for us. envirotainer.com ensure these gaps are adequately filled by the potential vendor. The Decision Prior to making a final choice, the sponsor company must determine who will partic- ipate in the vendor selection process and how the final decision will be made. Will all team members individually rate each vendor based on the agreed-upon crite- ria? Will the team make the final decision together democratically? Will the team make a recommendation to a single deci- sion maker? There are many ways to get to a decision, but how the final selection will be decided must be determined before the process even begins. THE RELATIONSHIP MUST BE A PARTNERSHIP Carefully selecting the right CRO or vendor is critical for small-sponsor success. Following our selection process, the cri- teria to select the vendor, and the decision of who has input and who makes the final determination will ensure selection of the 1 VENDOR CREDIBILITY: experience with small sponsors and programs, proven expertise in the desired therapeutic area, expertise in the geographic area, and specific technical experience 2 VENDOR CAPABILITY: customized planning and feedback on the protocol, plan, and timelines; right-sized tech- nology and reports; issue identification and resolution; team chemistry; strategic fit; and CRO executive involvement on a routine basis 3 BUDGET: clear and direct methods for budget management, straightforward process for handling budget or schedule changes, fair prices for services, willingness to negotiate Additionally, small sponsors must maintain open and honest communi- cation with potential CROs or vendors throughout the process. Honest commu- nication about existing gaps within the sponsor company should be shared to right high-quality vendor. This does not mean there won't be a critical need to have close management and oversight of that vendor, but alignment at the beginning can help. All parties at a sponsor company can more effectively work together to identify the best process to select a vendor and act on it if expectations are aligned at the outset. The relationship must be a partnership from the earliest stages, so approach it with that level of care and attention! L Katie McCarthy is managing director at Halloran Consulting Group. She leads the company's emerging biotechnology and pharmaceutical practice area. She has 18+ years of drug development experience. Connacht Peterson is senior consultant at Halloran Consulting Group. She has 11+ years of clinical development experience with a focus on clinical operations and development and global project management.

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