Life Science Leader Magazine Supplements

CRO Leadership Awards 2017

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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cation at an executive level. This level of communication should be mandated in every relationship, considering it is the biggest source of frustration for sponsors. In earlier stages of development, it may be beneficial to go with a smaller CRO and then shift to a larger CRO for later stages where the global reach is a better fit to conduct large programs. This isn't ideal for most com- panies to have to change relationships in a program, but it underscores the need for the sponsor to conduct development planning practices regularly. From the sponsor's viewpoint, one of the biggest disappointments in outsourcing is how the day to day work gets done, documented, overseen, and commu- nicated. Every CRO project manager has likely encoun- tered a sponsor manager who micromanages and crit- icizes every activity and deliverable. There need to be efficient communication channels between subject matter experts to build shared operational models that don't bottleneck through the project managers. For example, at one client, we recently encountered four dif- ferent groups that all thought they were responsible for managing the CRO, creating a lot of miscommunication. At the outset, it is important to realign your busi- ness processes to cover the changes that outsourcing brings. Many companies that embark on a significant outsourcing change have SOPS that are irrelevant to the business model. The most effective way to measure the health of the relationship is to look to the individuals and teams to do it. Surveys are a tried-and-true method but should be performed by both the sponsor and vendor as well as with any type of contracted service provider and investigators. In summary, professional relationships are the most loyal and yield the greatest results when they are treat- ed as personal relationships. Managing and checking-in on the relationship are the keys to fostering a strong partnership, regardless of shareholder return. L line and define a set of metrics with options to refine the metrics at predefined milestones. KPIs should be tailored to the critical aspects of your programs and shaped by: ▶ Determining how metrics will be available — ide- ally in a program that is continuously updated to maintain visibility. ▶ Appointing stable relationship managers to actively recognize when KPIs need refinement and manage the adoption of new metrics. However, two issues can arise with data identification: ▶ Study teams frequently want a deluge of data that is not valuable for identifying areas of improve- ment or best practices. ▶ Inconsistency in what data teams want ensures that systemic relationship issues cannot be iden- tified across multiple programs. In midsize or large sponsor companies this can require several FTEs when most of the portfolio is outsourced. The value of metrics relies on the underlying data used to generate them. If you have 100 studies in your portfolio, what percentage of them should be perform- ing on track? One colleague who has managed this successfully says it should be a minimum of 95 percent. Gaining this insight is difficult, and the governance at a middle level needs to determine an appropriate trigger point above which remediation is needed. Another major requirement for healthy collaboration is retaining the interest level. From our conversations with sponsors who outsource as a business strategy, the bigger the spend, the higher the interest on the part of the CRO. This presents a major challenge to small sponsors who don't have a lot of money to spend each year with a large CRO. Our clients say that if large CROs think a long-term engagement will form, they will invest the time to build the relationship. Smaller companies acknowledge that they require more assistance than larger companies, and that is often a lot for the CRO to handle, but it illustrates the need for early, attentive, and transparent communi- LAURIE HALLORAN, BSN, MS is the president and CEO of Halloran Consulting Group, which she founded in 1998. She currently lectures at the Boston University School of Medicine and the Tufts Center for Drug Development Post-Graduate program. Relationship Enterprise Process Asset Study Investigator/Site Executive Steering Committee, Operations Committees, Quality Oversight Committee, Balanced scorecard: Accountable for the overall health of the relationship and for providing strategic direction, regional governance, and local-level knowledge sharing Provide oversight for enterprise-level issues & compliance requirements, e.g., corporate audit, training, learning events Quality standards, services operating manual, process scorecards, process flowcharts, RASIs, SOPs, CAPAs, continuous improvement; business process owners (BPOs) Asset operations meeting, asset-level performance metrics Provide oversight for asset-level issues and address any cross-study implications Provide oversight for study-level quality or operational issues Integrated quality management plan, operations meetings, study-level performance metrics Service provider-sponsor joint attendance on study team Provide oversight of site-level issues, sponsor specific country-based role, regional oversight lead: performs site oversight visits – risk based – issues tracked within agreed timeline, site audits, CRA oversight of site performance GOVERNANCE: JOINT OPERATING COMMITTEES LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2017 18 By L. Halloran MEASURING THE HEALTH OF CRO-SPONSOR RELATIONSHIPS CRO-SPONSOR RELATIONSHIPS outsourcing

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