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www.biopharminternational.com February 2020 BioPharm International eBook 23 to ensure a successful relationship. Meeting cadences and transparency at operational and management lev- els, feedback sessions, accountability on both sides, and an open-book work environment can lead to build- ing trust. Steps such as coaching and mentoring CRO employees and pro- viding them with a big picture can lead to a CRO feeling empowered. Finally, excellence in project man- agement is also essential to a win- win relationship (e.g., templating standard work, acting on potential failure modes, strategic and tacti- cal level metrics, and implement- ing Green Belt and LEAN projects to improve efficiency). Undoubtedly, the partnership will have to navi- gate through challenging situations. Illustrative scenarios describing issues and ways to resolve them are detailed in Table I. It is of ten helpf ul to v isual- ize how success and failure may lo ok ( Ta b l e I I). A col lab orat ive approach, instead of finger point- ing and defensiveness, is evident in the successful alliance. A CRO is empowered instead of being micromanaged. Finally, continuous improvement tools are employed to improve efficiency in a success- ful CRO partnership. CONCLUSION P a r t n e r s h i p s w i t h C R O s c a n indeed deliver substantial bene- fits. However, a successf ul CRO relationship, even with a reputa- ble CRO, is not a given. Beyond the obvious requirements, such as defining the outsourced work, due diligence in CRO selection, and the quality agreement, a sig- nificant investment of time and effort to build and maintain the CRO relationship is required to drive it to a success. By jointly following the strategies outlined in this article, the sponsor com- pany and the CRO can maximize their odds of success. REFERENCES 1. J. Rockoff, "Pharmaceutical Scouts Seek New Star Drugs for Cancer, Diabetes," WSJ.com, March 9, 2014. 2. J. Hughes and S. Price, "The Perils and Promise of Strategic Partnering with CROs," PharmaOutsourcing.com, March 31, 2016. 3. FDA, Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements (Rockville, MD, Nov. 2016). 4. ICH, Q10 Section 2.7, Management of Outsourced Activities and Purchased Materials, Pharmaceutical Quality System (2008). 5. A. Mire-Sluis et al., "Effective Management of Contract Organizations: Keeping the Product Pipeline Moving, Compliant, and Available," BioProcessIntl.com, Oct. 15, 2015. BP Partnerships for Outsourcing Outsourcing Table I. Illustrative scenarios describing potential issues with a contract research organization (CRO) and ways to resolve them. Scenario Resolution CRO needs to subcontract par t of ser vice CRO to audit the subcontracted CRO to ensure current good manufacturing practice (CGMP) compliance. Work accountabilit y is still with the CRO. Inaccurate documentation of manufacturing steps Contract facilit y's batch records did not accurately reflect the actual manufacturing process. Batch records was sponsor responsibilit y per the qualit y agreement. A qualit y agreement cannot exempt owners or contract facilities from statutor y or regulator y responsibilities to comply with applicable CGMP. The CRO violated CGMP by using a batch record that does not accurately reflect the manufacturing process, even though the batch record was consistent with what was set out in the qualit y agreement. Parent company receives 483s or warning let ter Although the parent company and CRO have separate qualit y systems and there is a firewall between the two entities, the qualit y culture can essentially be the same. The CRO should share what would be the necessar y changes they need to implement based on the parent company's audit findings with the sponsor. Table II. Indications of the extent of success for a relationship between a contract research organization (CRO) and sponsor. Least successful Most successful Qualit y agreement is in place, but systems are poorly aligned. A strong qualit y agreement is in place with well aligned systems. Ambiguit y leads to failure: ambiguit y results from a) poor qualit y statement of work (SOW)s and work packages, b) both sides having unclear and unrealistic expectations of one another, and c) CRO lacks big picture and has limited visibilit y into sponsor development plans and timelines. Clarit y leads to success: clarit y is evident from a) well writ ten SOWs and work packages leading to clear and realistic expectations of one another, and b) sponsor giving big picture and engaging CRO in development plans and timelines. Since issue escalation cadences do not exist, problems are not addressed until they metastasize. Finger-pointing and defensiveness are common. Issue escalation cadences rigorously followed. Potential problems are spot ted and addressed early; both sides explore root causes and develop potential solutions together. Dif ferences are jointly managed A mindset of "You work for us/we work for you" prevails. Work is either micromanaged by sponsors or " thrown over the fence" to CROs. "We are colleagues" mindset. CRO is empowered. Prevalence of collaborative approach. Lack of engagement and governance cadences. Best demonstrated engagement and governance cadences (e.g., meetings, driving clarit y in SOW, and relevant key per formance indicators) are in place. Lack of continuous improvement resulting in stagnant par tnership. Continuous improvement using tools such as Green Belt and Lean.