Life Science Leader Magazine Supplements

CRO Leadership Awards 2014

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2014 40 INDUSTRY LEADER insights can do the job alone, except in very limit- ed circumstances. Outsourced activities of any magnitude need directed over- sight from the sponsor in the form of an assigned individual or oversight body. A formal overseer or oversight group can track operational and performance metrics to be sure that expectations are being met from both sides. Proactive monitoring of performance allows for early detection of potential risks (e.g. attrition, need for retraining, addi- tional time spent on an activity, etc.). Additionally, the forum provides an excellent mechanism for the vendor to communicate any suggestions for pro- cess improvements that the sponsor should consider. When communication is not forced in this way, both sides tend to stay quiet unless there is an urgent need to speak. Opportunities for pro- gram optimization are lost. IF THIS IS SO EASY, THEN WHY IS OUTSOURCING COMPLICATED? Outsourcing becomes complex when the sponsor is too busy or inexperienced to properly engage its vendors. In these cases, consideration should be given to working with a third-party advisor or external group to assist the outsourc- ing effort. When doing so, it is necessary to remember that these firms are also vendors, and best results come from following the same best practice approach with them. Working with an advisor that understands your business and working with them over time affords the best results. Treating outsourcing as a strategic ini- tiative and following the approaches out- lined above will increase the likelihood of success. L 1. ENSURE THE OPERATIONS TEAM IS INVOLVED IN PROCURING SERVICES AND DRAFTING THE AGREEMENT. Often we have seen a procurement team struggle to translate input from the operations team to the vendor; fail to re- engage operations during discussions, even as terms and activities morph from original requirements; and throw the relationship (not even the agreement) over the wall to operations to struggle with. Involving the operations team also will allow the agreement to define the correct metrics and tracking mechanism as well as ensure there is clear under- standing of both the intent and wording of agreement. 2. SELECT THE BEST-FIT VENDOR, AND THEN TREAT IT LIKE A PARTNER. It is important for the sponsor to be realistic about their needs and about who will be a good fit for outsourcing. If budget is a top priority, which is com- monly the case, then tradeoffs will be required for certain services, infrastruc- ture, or other components. Once a spon- sor has made a realistic selection of the best-fit vendor, the mindset needs to be 100 percent in the direction of partner- ship (assuming the nature of the services is amenable). Problems need to be solved together, and there is no place for blame. Our view is that there is no perfect vendor, just as there is no perfect team member. What is most important is that the needed skills are present, the spirit and philoso- phy of the firms are aligned, costs are reasonable, and communication is open. 3. INVEST IN THE RELATIONSHIP. Another significant mistake is to imag- ine that an outsourced service provider Extracting The Value From Outsourcing By Applying Best Outsourcing Practices G R E G O R Y F I O R E , M . D . B y its very nature, outsourc- ing can be a double-edged sword. On one hand you could consider outsourcing as an approach to increase your geo- graphic reach, retain organizational flex- ibility or a smaller footprint, or achieve some other business goal. On the other hand, such opportunity comes with a bit of risk, such as unexpected cost overruns or poor quality of service. In the most extreme circumstances, patient safety may be put at risk or data integrity com- promised to the extent that work needs to be repeated and clinical timelines can be stretched. To unlock the true value of outsourcing while minimizing the risks simply requires you to pay attention to best practice learnings from the legions of outsourced projects that came before yours. Most importantly, proactively structure the outsourced arrangement in such a way as to optimize value and minimize headaches. The following are three best practices that all sponsors should employ to increase the likelihood of success in outsourcing. Gregory Fiore, M.D., is a Harvard-trained, board- certif ed physician and former biotechnology CMO. He is founder of SSI Strategy, a consultancy focused on pharmacovigilance and medical affairs. By G. Fiore EXTRACTING THE VALUE FROM OUTSOURCING BY APPLYING BEST OUTSOURCING PRACTICES 0 3 1 4 _ C R O _ I n d u s t r y _ L e a d e r _ F i o r e . i n d d 1 0314_CRO_Industry_Leader_Fiore.indd 1 2 / 1 9 / 2 0 1 4 1 : 5 3 : 1 8 P M 2/19/2014 1:53:18 PM

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