As the number of clinical trials in the Asia-Pacific region continues to increase, George Clinical, a contract research organization based in Sydney, Australia, has been well-positioned for expansion.
The firm is also growing to serve the well-established North American and European clinical trial markets. George Clinical specializes in a wide range of therapeutic areas including oncology, kidney and metabolic, cardiovascular, neurology, respiratory, endocrinology and medical devices.
Further contributing to George Clinical’s prominence is its affiliation with the George Institute for Global Health, a world leader in chronic disease and other research categories.
“What makes George Clinical stand out is the scientific leadership that we can provide in various therapeutic areas,” says Ullas Arabhavi, Head of Data Management for George Clinical. “We can contact leading researchers and principal investigators in key specialties, and we often have better availability to these experts than other CROs.”
Around 2013, the George Institute for Global Health was working on several key research projects that required external assistance. These projects included endpoint adjudication involving thousands of research subjects. The Institute asked IBM to help build databases for these projects. IBM also trained staff on how to use the IBM® Clinical Development solution, a clinical data management system from IBM Watson Health® that enables users to organize and analyze report data from anywhere in the world.
Cost savings
Provided CRO clients with more flexible pricing options for cost savings to provide a competitive advantage when serving a variety of clients and markets
Expedited self-sufficiency
Modular platform design and ease of use enabled George Clinical to expedite self-sufficiency in building and managing clinical trial databases
IBM Clinical Development expertise was transferred to George Clinical, whose staff also became self-sufficient in using the platform. George Clinical’s adoption of IBM Clinical Development proved to be timely, equipping the CRO with a transformative tool—just as the Asia-Pacific market for clinical studies entered a steep growth curve.
George Clinical’s Database Development team has grown significantly over the last decade. As IBM Clinical Development experts, the team can build clinical trial databases ranging from simple to complex designs and incorporating a diversity of modules.
Recently, George Clinical used the IBM Clinical Development solution to support several landmark studies that focused on diabetic kidney disease. These studies involved thousands of patients and large datasets, and the endpoint adjudication functionality of the solution proved especially valuable.
Building on its affiliation with a prestigious research institute and its prime location in the Asia-Pacific region, George Clinical has experienced a surge in growth. “Doing things with IBM Clinical Development helped us support our clients in terms of speed, accuracy and consistency,” says Arabhavi. “These are key advantages of this electronic data capture (EDC) platform, along with its ease of use.”
Early on, George Clinical discovered another IBM Clinical Development competitive advantage that helped win clinical trial contracts. “Working with a unified platform with all of the necessary modules has helped us, as well as flexible pricing,” says Arabhavi. “This gives us the agility to provide lower-cost vehicles to run projects for academic clients and smaller organizations and support trials in developing countries.”
“For example, if a sponsor is performing a study in India, cost is going to be a sensitive issue,” says Arabhavi. “Our rate card flexibility with IBM Clinical Development gives us an advantage over other providers who may not have geographic-specific rate cards. IBM also offers an academic rate card which is significantly less expensive when compared to commercial rates.”
One of the most critical steps in any clinical trial is endpoint adjudication, where medical experts and regulatory bodies determine if protocol-defined endpoints have been met. The endpoint adjudication process is essential to the overall safety monitoring plan for complex clinical drug and device trials. “IBM Clinical Development supports endpoint adjudication, which is something not many other EDC platforms provide,” says Arabhavi.
“IBM Clinical Development is helping us expand into new markets and support clinical trials in rapidly growing fields such as oncology,” says Arabhavi. “Addressing protocol amendments leading to mid-study updates that are typical with oncology studies is never easy. However, IBM has given us the ability to handle these changes efficiently. We feel that IBM Clinical Development is more robust than other EDC tools for late- phase studies with complex study designs.”
While continuing to grow in its original Asia-Pacific market, George Clinical is also expanding into Europe and the US and has established a global presence. By providing clinical research services to both the nonprofit and commercial sector, the firm is also well-positioned for engaging with clinician and patient groups.
“With IBM Clinical Development, we can support all areas of therapeutic studies,” says Arabhavi. “We have a good mix of all phases of clinical trials, from Phase One to post-marketing surveillance studies, and have concluded studies with huge patient populations. Things have gone well with IBM.”
In addition to using IBM Clinical Development for building databases, George Clinical is also taking advantage of the platform’s other functionalities, such as APIs. “In several of our studies, we’ve built APIs so the data flows into IBM Clinical Development from external sources,” says Arabhavi. “In the future, we will look at the platform for support on projects involving e-consenting and electronic clinical outcome assessment.”
When the COVID-19 pandemic started spreading in China, IBM began offering the IBM Clinical Development solution free of charge to eligible sponsors and CROs. Using this tool, George Clinical was able to rapidly set up databases to support Covid-related clinical trials. “Participating in the IBM Clinical Development free COVID-19 program is an example of the strong partnership we have built with IBM,” says Arabhavi.
As it has with so many other organizations, the COVID-19 pandemic has caused George Clinical to think about doing things differently in the future. “COVID-19 acted like a catalyst. During the next few years, we’re going to see what technology can offer, how it can enable us to do things more efficiently and keep quality at the center,” says Arabhavi. “We will keep on exploring the advantages of technology and look forward to IBM continuing to support us the way they always have.”
Headquartered in Sydney, Australia, George Clinical (link resides outside of ibm.com) is a leading global clinical research organization with over 20 years of experience and more than 350 people managing 38 geographical locations throughout the US, the Asia-Pacific region and Europe. The firm provides a full range of clinical trial services to biopharmaceutical, medical device and diagnostic customers for all trial phases, registration and post-marketing trials.
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