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Thursday, December 8, 2022

Elixia - Transforming Clinical Trial Conduct

The process in which clinical trials have been conducted has remained relatively consistent over the last 50 years- consequently, because of the inherent lack of innovation, along with sub-optimal execution across several key aspects of trial management, the industry as a whole is often characterized as painfully inefficient and ineffective.  One obvious, critical aspect vital to trial success has to do with patient acquisition relative to time. More often than not, the pace at which subjects are enrolled into trials is far too slow, forcing many pharmaceutical companies to push back their regulatory submission deadlines, which then results in delayed regulatory approval and initiation of new standard of care therapies, commercially. Elixia, a disruptive, forward thinking clinical trial management company based in Florida is at the forefront of attacking the patient acquisition challenge, along with several other key aspects integral to clinical trial management and overall success. Lessons learned from COVID-19, the industry saw that it is infact possible to achieve high trial success in record time, as evidenced by the number of trials and new drug applications that ultimately received regulatory approval. “As a company, we have two divisions. One focused on organic drug development and MOA design, and the other on clinical trial planning and management. Trial management is certainly our primary focus, and through collaborations with pharmaceutical companies, our mission is to help optimize the success of as many pharmaceutical companies as possible through their New Drug Development and Regulatory Approval Process,” explains Neal Patel, CEO, Elixia.

The How:

This is achieved by carrying out pharmaceutical trials within our facilities across the country and associating specific physician networks with each trial. This highly selective process for patient acquisition ensures that the patient enrolment timeline is as short as possible. Through each of the trials, vital information regarding the drug’s safety profile, efficacy, and long-term application are measured and presented back to the pharmaceutical company so that they can compile this data across all of their sites around the world ahead of regulatory presentation. The patient acquisition model employed by Elixia is one of seven key performance indicators that Eixia does differently than all other trial management companies around the world. This truly re-developed clinical trial management process is warranted in order to keep up with the pace of new drug development from pharmaceutical companies around the world.

A Proven Track Record

The most recent example of how Elixia’s forward thinking strategy significantly enhances the success of clinical trials was seen through the COVID-19 Pandemic. In 2021 Elixia demonstrated the highest volume of enrolled subjects, in the shortest time frame of all sites globally. Through this trial, Elixia then successfully managed and supported the greatest number of enrolled patients in any clinical trial in the last 50 years. Holding 76% of all of the data for this particular drug, globally, Elixia’s team had to process through 30,000 data points a day, 7 days a week for 11 months. Through such commitment and passion for advancing the new drug commercialization process, Elixia was able to shorten the timeline for FDA-Emergency Use Authorization from 12 months to 4 months. “We’re now doing that exact same thing for about seven other companies this year, not just in the infectious disease space, but in the Nephrology and Behavioural Health space. We are transforming clinical trial conduct and management, not just from the time perspective, but from the quality perspective as well. Moreover, as a young company, we did something that’s never been done in the last 50 years and we will only continue to raise the bar with every new successful trial completed,” extols Patel.

The Blend of Passion and Innovation

Today, Elixia is guided by its CEO Neal Patel and a highly skilled and experienced team. Patel is a healthcare and biotechnology entrepreneur in both the Pharmaceutical and Biomedical marketplace. Patel founded his first clinical diagnostics company, at the age of 23. With a passion for enhancing the accessibility to healthcare for disparate communities, Patel launched a private R&D Laboratory, responsible for engineering disruptive, cost-effective diagnostic tests focused on several cardiovascular indications. Over the next 3 years, Patel developed one of the largest dedicated Cardiology networks for molecular diagnostics and clinical research on the east coast. Maximizing the power of strategic foresight, Patel began developing a crossover network between Cardiology and Nephrology and this led to the founding of Elixia.

Over time, Elixia’s Cardio-Renal Network became the largest dedicated footprint for clinical trials in the Southeast and is currently the fastest growing clinical trials footprint within the Cardio-Renal specialty in North America. Under Patel’s leadership, Elixia’s total enterprise value has more than quadrupled, the number of employees tripled, and the company has received numerous accolades for its work across several therapeutic focuses.

Since opening its doors, Elixia has been a pioneer in delivering out-of-the-box clinical trial management solutions. Elixia’s integrated and technology-forward approach provides a new suite of capabilities to improve the efficiency of clinical trials. Today, it is Patel’s unrelenting passion for innovation as well as his experience that is driving Elixia to success.

Elixia’s mission is to redevelop the landscape in which clinical trials have been conducted over the last 50 years and deliver a new environment where Clinical Trial Rollout, Conduct, and Management can occur at a breakneck pace with an unparalleled level of quality.

Elixia
E

Neal Patel, CEO

www.elixiahealth.com

“The lack of innovation and poor execution in the clinical trials industry is whats caused the market to be characterized as inefficient and often ineffective. With a more tailored approach, we can transform the way clinical trials showcase success around the world and ultimately help to perpetuate faster regulatory approval for new molecules that have the ability to save patient lives and improve quality of life everywhere”

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