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22 BioPharm International eBook February 2020 www.biopharminternational.com The importance of a strong quality agreement was also emphasized in a CASSS organized chemistry, manufacturing, and controls strat- egy forum in 2014 (5). ALLIANCE FORMATION AND STRATEGIES Key steps in the formation of a strategic alliance with a CRO are shown in Figure 1. The win-win strateg ies can be g rouped into three categories: strategies that can drive a solid foundation, soft factors, and excellence in project management ( Figure 2). Qualit y track record, firewall polic ies, dept h a nd breadt h of capabilities, resource pool in the local area, CRO financial situa- tion, and the current management team are some of the important considerat ions in a CRO selec- tion process. Clarity in statement of work (SOW ) and work pack- ages is of paramount importance Partnerships for Outsourcing Outsourcing Figure 1. Key steps in forming a strategic relationship with contract research organizations (CROs) Define Due diligence MSA and QA Cadences Follow through • Master service agreement (MSA) and quality agreement (QA) with the selected CRO(s) • Address technical, business, and quality aspexcts • Work initiation, including transfer work • Establishing engagement and governance cadences • Quality audits • MSA and QA renewals • Define what work stays in-house and what is outsourced • Define key drivers; speed, cost, work complexity • Technical assessments • Supplier quality audits Figure 2. Key strategies in building a win-win relationship Project Management Excellence Soft Factors Solid Foundation Win-Win Strategies Continuous Improvement Metrics CRO Selection Simplifying The Complex Quality Management Empowerment Build The Trust Clarity In Expectations ALL FIGURES COURTESY OF THE AUTHOR.