Although most oncology/hematology Phase I trials share the same challenges and follow familiar designs, the conduct of each and every study may bear pitfalls, complex issues, first-in-man curiosity, and/or relatively new targets. These all require intensive yet clear communication and careful consideration for all stakeholders (sponsor, investigators). At INC Research, setting clear expectations, managing teams and partners, and the use of real-time data are all ingredients of our data-driven operational mindset. With our extensive global reach, we can deliver the services clients need, even at the Phase I stage, regardless of sponsor and investigational site locations.

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A Phase II study that initially started as a pilot AML/MDS study with a few dozen patients, evolved from a 2nd tier supportive study into a pivotal Phase II study. Through the ProgramAccelerate phase of our Trusted Process, we recruited over 160 patients across sites in North America and Europe. INC Research displayed flexibility to client needs and provided proactive study management that helped drive this study evolution while providing the continuous study updates required by the client.

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INC Research performed project management and data management services for a Phase IIIb study conducted in 52 countries, with study sites recruiting 8,000 patients. The challenge in this study was to blend client-driven clinical monitoring with INC Research services, thus operating as service provider for client’s headquarters, as well as the dedicated liaison for all 40 involved international affiliates and partners. INC Research successfully maintained relationships with all stakeholders in a “lean-and-mean” Phase IIIb operational setting. Notably, during conduct of this study and its QualityFinish, the accrued data has served scientific needs while also increasing marketing information both from the client’s headquarters’ point of view and from a local affiliate perspective.

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