Health Decisions builds network of international CROs to improve
clinical trials research
9 February 2010
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
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
is 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.
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
“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.”