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The partnership is an example of how CROs and sponsors interact in the ever-evolving clinical trial industry.
Two years ago, i3 Statprobe and Eli Lilly embarked on a functional services provider (FSP) relationship that had i3 taking over the majority of Lilly's US data management work. In September 2010, the two companies expanded their FSP relationship with i3 taking on US-based medical writing, biostatistics, and statistical programming. Aarti Shah, PhD, Vice President of Statistics and Advanced Analytics Hub at Eli Lilly told Applied Clinical Trials, "Having a good relationship and being able to leverage that relationship was very critical. This is a true partnership. We don't view them as a vendor."
As the relationships between CROs and sponsors evolve and become more strategic, the i3-Lilly partnership appears as an example of how these FSPs really work.
Gregg Dearhammer, Group President, i3 Statprobe and i3 Drug Safety, gives Lilly a lot of credit for being on the forefront of these initiatives and making them work. "We have a committed, robust governance structure with multiple points between that allows both companies to have strategic alignment on all levels," explained Dearhammer. He also says that keys to the successful relationship, on which they are able to build, are a clear commitment from senior level management to these relationships, and Lilly's ability to walk the walk. "Our discussions aren't always happy, but we are always able to deal with each other as professionals, and we are committed to working through any issues."
Shah concurred and said that the FSPs are part of Lilly's FIPNET (fully integrated pharmaceutical network) strategy to move forward in its portfolio development. For i3, Dearhammer explained that it recognized FSPs and more strategic relationships to be the trend and, for the past four years, has supported this structure as its business model. i3 has approximately 12 more active FSPs besides Lilly, with varying degrees of complexity. "We are getting more requests every week from sponsors that look at our relationship with Lilly and are re-evaluating how they do business," said Dearhammer. Dearhammer has started to see a change in sponsors' view of drug development.
Since last spring, interest in FSPs has been increasing, as sponsors realize they have to be more strategic. "They have to choose what they are good at and focus on that—bringing the science and the molecule to market—and leave the process to us," said Dearhammer. "They are looking at more strategic ways to save on costs."
In the immediate future, with the transition of the next phase of operations moving over to i3, Shah doesn't envision any problems. "With this transition, there will be no interruption in portfolio delivery," she said. "We have the experience with them and we are confident that it will be successful."
— This article originally appeared on appliedclinicaltriaslonline.com, October 21, 2010. inVentive Health announced the acquisition of i3 Statprobe on January 20, 2011.