(Durham, N.C.) Health Decisions (www.HealthDec.com), a full-service clinical research organization (CRO) specializing in adaptive solutions, plans to raise the standard of efficiency in global trials through its new, international CRO community built on the company’s Agile Clinical Development methodology. Through 20 years of experience in clinical research on a global scale, Health Decisions has fine-tuned the Agile approach—which combines adaptive design with adaptive operations—to form a set of best practices which consistently cuts trial timelines, increases transparency, and delivers vastly improved results. Now, the company has taken the initiative to identify CROs around the world that embrace this Agile methodology, providing training, certification and partnership opportunities that will help alleviate the industry’s struggles with complex, multinational programs.

“It’s no surprise that, as development moves overseas, disparate systems and gaps in information inevitably drive up costs and prolong development timelines,” said Health Decisions Chief Operations Officer Rick Farris. “This network will serve as an incredibly valuable resource to combat inefficiency in global clinical trials, getting new products to market more quickly while maintaining the highest levels of data integrity and patient safety.

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’ robust internal training system, which features easy-to-use, 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.

“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,” added 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.”

For more information regarding the certification processes and prequalification requirements, please visit www.HealthDec.com/page/agilenetwork or contact us at AgileNetwork@HealthDec.com.

Health Decisions (www.HealthDec.com), a global clinical research organization (CRO), leads the industry in trial efficiency. Through integrated technology and agile clinical development methods that apply adaptive principles to both trial design and operations, Health Decisions provides sponsors unprecedented transparency and control and produces results 10-40 percent faster than traditional approaches.

Health Decisions is headquartered in Durham, NC, with over twenty years of drug development experience in setting new standards of speed and accuracy for pharmaceutical, biotech and medical device companies in Phase I-IV trials across all major therapy areas. For more information, please visit the company’s website at www.HealthDec.com.