Building Effective Relationships with CROs
December 21,2015 Sarah Stapleton

The biopharmaceutical market faces a lot of challenges where speed and quality are key elements in successfully getting a product through drug development to market. The ability for pharma and biotechs to progress a compound more quickly and safely through each phase of research without sacrificing safety as well as quality is essential to maximizing revenues.

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One way that can help to reduce costly delays and maximize speed while maintaining quality is to build an effective relationship with the CRO conducting clinical trials. The key word here is effective. We’re not talking about simply having a preferred provider contract in place or the like, rather a true relationship where a sponsor is comfortable doing more than just awarding a study and confident in the CRO they will partner with.

Perhaps think of it this way, Clinical trial units conduct clinical trials. Duh, right? What we’re saying is that conducting clinical trials is their specialty. It’s what they do all day long, every day for 365 days a year. Why wouldn’t you trust the expertise of such a resource to aid you by reviewing a protocol, assist with an adaptive design for a study or discuss the operational conduct of your specific trial?

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Fun statistic: by combining a SAD study and MAD study into one umbrella protocol a sponsor can save an estimated 4-12 weeks off their timeline (depending on the study design). By combining several protocols into a single umbrella protocol, sponsors can evaluate multiple endpoints and achieve multiple objectives at once, which translate into both time and cost savings. Working effectively with a CRO enables companies to efficiently manage their drug development pipeline by looking at study designs and operational feasibility which in turn can help sponsors to determine where time and money can be used most successfully.

The most important aspect in building an effective relationship with a CRO is to develop open and consistent lines of communication. Being able to properly communicate is the essence of a a true collaboration and it is invaluable because it can significantly reduce costly delays from protocol concerns/amendments, recruitment hurdles, clinical conduct and other important milestones. By keeping a line of communication current and open, trust and rapport are built with the CRO. A dedication to rapid responsiveness by a CRO can create a sense of being part of a sponsor’s organization which can lead to better study conduct and hopefully reduce costly delays.

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