Sean Hart, Chief Business Officer
Competition in the clinical trial markets across the US, Europe, and the APAC region, continues to get fiercer every day. In an attempt to get ahead of the rivals to market, pharmaceutical and biotech companies are keen to unlock opportunities in emerging markets through abundant and diverse trial populations, while also reducing operational costs. Meanwhile, as clinical research has evolved, governments across the globe have increased regulatory requirements to ensure patient safety along with the efficacy and safety of new drugs. As a result, an unfortunate reality of clinical trials today involves navigating through the complex regulatory landscape and enduring high costs of conducting clinical trials. Although the benefits of expanding clinical research to more countries are evident, pharmaceutical, biotech, and medical devices companies lack the understanding to operate and execute in foreign countries, which are already saturated with clinical trials. This is where regulatory factors, poor site selection, and low patient enrollment rates can impede conduct of a clinical trial and can easily derail and delay them.
Set against this backdrop, how do small and medium-sized biotech companies conduct clinical trials in a better, faster, cheaper, smarter, and more consistent manner?
It is hard to find a clinical research organization (CRO) better equipped to answer this question than George Clinical. As one of the leading global CROs, with 20 years of industry experience, George Clinical provides a full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration, and post-marketing trials. With operations throughout the Asia-Pacific region, the US, and Europe, George Clinical is singularly focused on one mission: to empower companies with its global service delivery, world-class scientific leadership and therapeutic strengths in renal, cardiovascular, oncology, and respiratory disease for improving the health of millions of people worldwide. According to Sean Hart, Chief Business Officer, George Clinical, the company’s winning differentiator is their scientific expertise. The company’s deep ties to key opinion and scientific leaders in the areas of renal, cardiovascular, oncology, and respiratory therapies have been instrumental in the formulation of the best policy, the delivery of best practice, and the short- and long-term planning with its pharmaceutical and biotech clients. “In collaboration with these well-known leaders, we have created a differentiated service called scientific leadership, whereby these leaders work across the globe to stimulate enrollment—the number one problem in all clinical trials—energy and enthusiasm for a trial. The fact that these key scientific leaders are native to the countries we are expanding in helps us to gauge the clinical trials feasibility,” explains Hart. In essence, George Clinical’s presence across Australia, China, India, Hong Kong, Taiwan, South Korea, Malaysia, New Zealand, United Kingdom, and the United States, along with its extensive series of investigator networks, provides the customers with customizable clinical trial excellence.
From clinical trial design to all aspects of clinical trial delivery, George Clinical navigates small and medium enterprises through all phases of clinical research with its high-quality services. Unlike large pharmaceutical companies, small and medium enterprises have limited resources that are directed toward moving their product pipeline from clinical trials to product launch.
Teams are typically small and nimble, and price points differ compared to the products of large companies. George Clinical primarily caters to such small and medium enterprises that lack the expertise in conducting clinical trials. Backed by George Clinical’s innovative solutions, customers can access patient populations and reduce sponsor R&D costs, ensuring that their clinical trials have an impact on clinicians and patients.
We have created a differentiated service called scientific leadership, whereby these leaders work across the globe to stimulate enrollment—the number one problem in all clinical trials—energy and enthusiasm for a trial
A typical client engagement at George Clinical begins with in-depth discussions between the company’s scientific leaders and operation teams and the client about their product. This involves walking the client through the development path, the clinical trial planning, the ways they can meet patient recruitment goals to reach the next phase of their clinical study, and more. These discussions in the early phase of the development eliminate the uncertainties small to medium-sized companies have. As a trusted partner, George Clinical allows the client’s diverse questions to be answered and empowers them with valuable insights to ensure that the studies are conducted in the best way possible. The flexible, responsive, and high-quality services have been designed keeping the customer experience at the forefront.
It is only after the George Clinical team has acquired an understanding of the study and ensured the protocols are in place that it brings its scientific leadership into play. George Clinical’s scientific leadership service supports sponsors in the setup of key trial committees by selecting and contracting world-renowned and experienced committee members that the company accesses through its global scientific networks. This peer-to-peer engagement with investigators results in strong operational delivery, protocol alignment with clinical practice across geographies, and seamless communication conduits between the stakeholders. Companies can get access to the key opinion leaders—who are well placed to identify and address requirements for innovative and pragmatic clinical trials—at four to five sites in a particular country, explore the trends in the area of the therapeutic discipline, seek answers to their questions, and more.
At a time when the clinical trial process remains riven with pain points, George Clinical is successfully helping its customers to expand their clinical research to more countries around the globe. George Clinical recently engaged with one of the customers to assist them in conducting clinical trials in the therapeutic discipline of chronic kidney disease. The customer was faced with obstacles while recruiting in the US and Europe and therefore had to enroll in a global program. George Clinical stepped in and effectively helped conduct an in-depth feasibility assessment in the Asia-Pacific market. Both the operations team and the renal experts from George Clinical orchestrated the launch of the global program. This involved evaluating the client’s ability to engage with the native population of specific countries, hold monthly or quarterly meetings, and let the patients understand the key benefits that differentiated their product. “Apart from Asia-Pacific, we also found key scientific experts in Europe and the US in order to work with another large global CRO. We then empowered them with our scientific leadership model, which allowed for the enrollment to be completed by the best sites and institutions across the world,” adds Hart.
Scripting similar success stories, George Clinical is expecting to grow and continue delivering high customer value in the coming years. At present, the company is looking forward to investing heavily in the oncology expertise, catering to the rarer type of cancers such as glioblastoma through profound research on certain genetic types. “We will extend our scientific expertise in oncology across the US and Europe as well as the Asia Pacific,” states Hart. The company also has extensive plans to explore the horizons of pharmacovigilance and endpoint adjudication.