Life Science Leader Magazine Supplements

CRO Supplement 2015

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THE CRO LEADERSHIP AWARDS 2015 LIFESCIENCELEADER.COM 32 KEY BUSINESS DECISIONS insights my turn to present my small company, I went around the table, introducing the CEO, a couple of vice presidents, and myself. At that point someone from the CRO asked if they would have the oppor- tunity to meet the operations group at a later date. He didn't understand that this was it. Everyone on our team was already on the phone." That incident upset Strause, eventually resulting in her bringing it to the atten- tion of senior management at the CRO. What was clear to her was that larger CROs needed to do their homework bet- ter prior to sitting down for a kick-off meeting. "When dealing with a virtual compa- ny, you need to know something about them going in," she notes. "There are a lot of things those companies don't do. Throughout that meeting, we were asked a lot of questions about things that did not specifically apply to our protocol. We received budget spread- sheets that included Asia, Europe, and other places around the world, when the company was doing a small study in North America. If someone is going to take time from several executives to hold a meeting, they should first deter- mine if it is even necessary. If they had done their homework and understood the company, a lot of time could have been saved. Presentations should always be personalized for the company sitting at the table." Strause notes finances are also very important to her. Small virtual firms do not have the budgets of many larger com- panies. When working with large CROs she gets tracking of budgeted versus actual costs but projecting expenses into the months ahead would help to manage limited financial resources. "Some CROs think they can pass along any costs they incur," she says. "I am the client and I have to pay that bill. I am the one who gets stuck with it. I have a bucket of money with nothing going in but a lot coming out. I have to manage that money very differently than a large pharma or biotech company. It is vital for the large CRO to work with me and help me to make intelligent decisions and projections." ll are noteworthy consider- ations, but if you're a small pharma or biotech company, you have an additional deci- sion to make: what size CRO do you go with? Linda Strause, Ph.D., principal and founder of Strategic Clinical Consultants, has helped many small firms navigate through this decision. A large CRO can bring a lot to the table for a small pharma company. They generally have a number of silos dedicated to every component of a clinical trial, including study start-up, clinical operations, risk-based monitor- ing, statistics, data management, and proposals. Unfortunately dealing with a large CRO can also have some draw- backs. One of the first drawbacks is get- ting them to understand the mindset and capabilities of a small company. "I recently had the opportunity to deal with a large CRO," says Strause. "We had an introductory phone call to get to know each other. The folks with the CRO all introduced themselves. When it was By E. Miseta SMALL PHARMA AND LARGE CROs: CONSIDERATIONS FOR PARTNERING Small Pharma And Large CROs: Considerations For Partnering E D M I S E T A Executive Editor @OutsourcedPharm When it comes to selecting a CRO, pharma companies have a lot of decisions to make. Do you go with a CRO that has experience and expertise in your study? How should you rank their proficiency in critical areas such as regulatory, quality, and timeliness? Do you go with a CRO you have familiarity with or try something new? A

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