Could you provide a brief introduction to Global Clinical Trials (GCT)?  

GCT has been active for over 17 years, with our first clinical trial having taken place in St. Petersburg, Russia. In 2003, we opened our first U.S.-based office in Princeton, New Jersey, mainly for administrative purposes and to increase presence in the United States as a majority of our clients are based here. We have gradually expanded our geographical footprint, increasing our operations across Central and Eastern Europe, and we recently opened a new office in Mumbai, India. Our strategy for expansion is to find the right personnel with long-term industry and market knowledge, thus providing our clients with full support on the ground to deliver regulatory approvals on time. We are currently managing numerous studies across the mentioned regions.

What is GCT’s value proposition for small U.S.-based biotechs?

GCT’s value proposition is our competitive pricing, quality assurance and fast patient recruitment. Pricing is one of the primary concerns for a small biotech and GCT can offer one of the most competitive CRO rates in the United States. Furthermore, with our strong presence and quality assurance department located in Europe, we can promise and deliver high quality. Majority  of the sites that GCT uses have been visited and inspected by the FDA, EMA or local health authorities.

Moreover, research sites in Eastern Europe are based in large hospitals and regional centers, thus eliminating the risk of a potential shutdown. We also have very high level of patient compliance in Eastern Europe. In Eastern Europe, patients are more open to participate in clinical trials unlike in the United States and Western Europe where there is access to breakthrough therapies and early access programs outside of clinical trials. For example, we organized a number of studies sponsored by a West Coast biotech company that was seeking a particular naive patient population. Conducting this study in the United States would entail several challenges in recruitment due to the population not being treatment naive.

GCT is typically involved in Phase II to Phase III trials. Could you outline your therapeutic focus?

Oncology is a major therapeutic focus for GCT as currently a quarter of all industry sponsored clinical trials are in this space. As a company, we also have a major focus in CNS, ophthalmology, reproductive health and gastroenterology. Within women’s health, we have participated in one of the largest clinical trials recruitment wise for preterm birth with over 1700 participants globally in the United States and Europe.

The majority of our project managers and CRAs are medical doctors, so if, for example, we have an oncology trial, our proposed lead clinical research associate (CRA) would be an oncologist by training, which is a great advantage for the monitoring of data and helping to understand standards of care in different countries. As a small to medium-sized company, we are strong in every therapeutic area we work in.

As the CRO industry landscape is becoming increasingly consolidated, how is GCT able to reach new clients?

We procure new clients primarily through references, but we currently have a strong base of preferred partnerships with biotechs and Pharma from Massachusetts, California, New Jersey and Europe that work with us on a regular basis. For example, one US-based Pharma gave us five late-stage projects across seven years. Nonetheless, we increase company recognition by exhibiting and speaking at the major industry conferences.

How have you seen the biotech ecosystem change in New Jersey over the past five years?

There has been a drastic increase in the number of biotechs in Princeton over the five years. It is interesting to see how small biotechs access funding for their trials and then go on to be successful components of the New Jersey biotech landscape. The biotech industry in New Jersey is constantly changing with many companies coming from other states, including Philadelphia, Delaware and even California.

What are GCT’s key objectives moving forward?

The key objectives moving forward will focus on further growth in the United States. Asia is an active market that we might consider for further expansion after careful evaluation in the future. Moreover, we hope to increase our service offering in response to client demand as well as new regulations, for example the new GDPR requirements in the European Union.

Could you provide a final message from GCT to the U.S. biotech community?

As a company, GCT looks forward to establishing new and reliable partnerships with companies in the biotech industry. Our role is to provide a bridge between patients and biotechs globally in order to find innovative, life-saving treatment options and provide access to patients all over the world.