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Health Decisions, a full-service clinical research organization (CRO) specializing in adaptive solutions, is raising 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.
Key to Health Decisions' adaptive approach is the use of SmartPens, which use Anoto's Digital Pen and Paper technology. The digital pen automatically records and digitally converts clinical trial data as it's being logged by investigators. Once downloaded and collated, data can immediately be shared with the CRO and the sponsor. Consequently, both parties can track progress faster than is otherwise possible, and adapt the trial as required.
"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 also addresses the technological capabilities necessary for successfully adapting both design and operational components. Partner CROs will gain access to HD360°, Health Decisions' new, streamlined trial management software designed to enhance the productivity and decision-making capabilities for every study role. Additionally, these partners will receive training on a range of data capture tools, including the SmartPen advanced EDC system, which Health Decisions has identified as optimal for capturing fast, accurate data and shortening the distance between information and decision-makers.
Health Decisions' robust internal training system
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 about the certification processes and prequalification requirements, visit www.HealthDec.com/page/agilenetwork.
About Health Decisions
Health Decisions, 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.
About Anoto Group
Anoto Group is the company behind and world leading in the unique technology for digital pen and paper, which enables fast and reliable transmission of handwritten text into a digital format. Anoto operates through a global partner network that focuses on user-friendly forms solutions for efficient capture, transmission and storage of data within different business segments, e.g. healthcare, bank and finance, transport and logistics and education. The Anoto Group has around 110 employees, offices in Lund (head office), Boston and Tokyo. The Anoto share is listed on NASDAQ OMX Nordic small cap list under the ticker ANOT. For more information: www.anoto.com. |
