Durham, NC—October 15, 2009
Health Decisions hopes to raise the standard of efficiency in global trials through its new, international CRO community built on the company’s Agile Clinical Development methodology—which combines adaptive design with adaptive operations. The company has recently taken the initiative to identify CROs around the world that embrace this Agile methodology, providing training, certification and partnership opportunities in an effort to help alleviate the industry’s struggles with complex, multinational programs.
“Our goal is to identify like-minded organizations across the globe that embrace the idea that we, as an industry, can run better global studies,” said Health Decisions Chief Operations Officer Rick Farris. “Regardless of what they call it—Agile Clinical Development or otherwise—if they’re comfortable with adaptive techniques in both design and operations, and pride themselves on relentless efficiency in clinical research, we want to talk to them.”
The new global training program focuses primarily on adaptive operations, which, once the proper infrastructure is in place, are effective and easy to implement for all types of trials—regardless of complexity or geographic area. An adaptive operational infrastructure is also necessary for optimal, successful design adaptations, which must be executed on a trial-by-trial basis according to a study’s specific characteristics. Once the network CROs are certified in Agile operations, Health Decisions will work with them to implement adaptive designs as needed.
The program is built on Health Decisions’ internal training system, which features Flash-based online courses that cover every aspect of clinical trial management, concentrating on Agile techniques that can help every trial run more smoothly. Health Decisions is opening up this system to its partners for the first time, offering courses that include:
- Agile Clinical Trials 101
- The Anatomy of a Study
- Applying Regulations in the PM Role
- CRA Fundamentals
- Remote Monitoring
- The Agile Research Site
- Agile Technology and Reporting
The first group of CROs is currently undergoing Agile certification coursework, with several more in the final stages of the pre-certification process. The geographic coverage of these companies includes South America, Eastern Europe, Western Europe, Asia, Africa and Australia.
