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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Measuring The Health Of CRO-Sponsor Relationships L A U R I E H A L L O R A N , B S N , M S to. If the arrangement is initiated and managed well, there is a better likelihood of identifying risks and pre- venting problems down the road. These relationships require continuous effort on both sides, and that effort is not to be underestimated. A relationship catastrophe is often seeded in the early days of an outsourcing decision. For example, recently we were involved with a company that had an executive mandate to outsource with a midsize pharma com- pany. They needed to become more efficient after two products were beaten to market by competitors. Since their end-of-year deadline was handed down from the C-level, there was a scramble to choose and begin a complex relationship that the majority of the devel- opment team had never encountered. Red flags were everywhere. Rushing the start of a new outsourcing model without the necessary support and insights can lead to missteps in the process. Instead, it is imperative a company allocate — up front — the appropriate time needed to learn how to work efficiently in a new out- sourcing paradigm. AVOID MISSTEPS WITH MASTER SERVICE AGREEMENTS Contractual documents are almost impossible to draft without understanding future challenges. When spon- sor companies elect to move to strategic outsourcing, many thorny issues arise when hastily negotiated Master Service Agreements (MSAs) are executed. This is a crit- he market for CROs continues to consol- idate, and many of these businesses are becoming as large as or even larger than the companies they serve. But no matter what size the sponsor (nor whether it's public or private), shareholder return from profits of newly marketed products is always going to be a primary business goal. CROs, on the other hand, are service providers focused on selling their time. This difference between these entities sometimes creates a conundrum of imperfectly aligned business objectives that can be a major source of problems if not managed from the onset. While small or early-clinical-stage companies are required to minimize their fixed costs through out- sourcing, midsize and large companies seek more stra- tegic relationships and single-source providers to tackle the challenges associated with both speedy program execution and cost containment. Thus, when collabo- rating with CROs, life science companies face complex challenges that obviously can impact clinical outcomes. However, there are a number of proactive approaches to take in working with CROs to manage relationships, align objectives, and reap benefits for both parties. MITIGATING CRO-LIFE SCIENCE COMPANY RELATIONSHIP CHALLENGES The health of these relationships is critical and is an often underlying cause of project failure if not attended T As the majority of clinical trials involve external collaborations, healthy relationships between a sponsor and its partners (e.g., CROs) cannot be overemphasized. In this article, much of what we will discuss pertains to the relationship between a CRO and its sponsor, the life science company. However, any company providing a contracted service to a sponsor will find there are valuable lessons to be learned regarding relationship management. CRO-SPONSOR RELATIONSHIPS outsourcing By L. Halloran MEASURING THE HEALTH OF CRO-SPONSOR RELATIONSHIPS LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2017 16

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