Discussing a new model for global research with Applied Clinical Trials

Posted on Dec 14, 2009

We recently got a chance to chat with Applied Clinical Trials’ Lisa Henderson about our new network approach to global clinical development. Coming face to face with breaking industry trends on a daily basis, Lisa is no stranger to the ubiquitous cries of drug developers for a faster, more efficient, and all around better way to run clinical trials. So it was especially enlightening to get her take on our new model for drug development on an international scale.

By identifying qualified CROs around the world to undergo our training and certification process, we’re building a network of free-standing, individually empowered research partners that are equipped to run trials according to the highest standards of our Agile Clinical Development methodology (see below for what that means). With these skills and tools in place, the network offers a much-needed alternative to behemoth CROs with offices all over the world--each of which is too easily bogged down by traditional methodology and a limited ability to react to problems that arise on the fly. Through the network, our sponsors capitalize on the geo-specific cultural and demographic expertise of our partner modules without sacrificing flexibility, transparency, or control over their trial’s progress.

What is the Agile Clinical Development methodology we’re bringing to our global partners? “Don’t confuse Agile Clinical Development with adaptive trials, which is what I did,” writes Lisa in her blog post. “While Health Decisions does offer protocol design services and has a very strong biostatistics department that can bear on an adaptive design trial, agile and adaptive in this sentence are synonyms.” The difference, stated by our COO Rick Farris, is that Agile incorporates adaptive operations that can be used on any kind of trial, whether its design is adaptive or traditional. It’s the idea of knowing what’s going on in your programs as early as possible—particularly for complex international trials where a lot of potentially mitigating factors are at play. For more info on Agile, contact us or read an overview here.