Wake Research, an integrated national network of clinical investigative sites and one of North America's leading providers of Phase I-IV clinical trials, was recognized as a Top Enroller of patient volunteers by Novavax, a Maryland-based biotechnology firm, in their COVID-19 Phase III vaccine clinical trial. Since hosting the official commencement of Operation Warp Speed with Vice President Mike Pence during his visit to the Research Triangle in 2020, Wake Research has helped lead the nation's efforts to provide high-quality trial data on COVID vaccines to help several vaccines get the greenlight from the FDA.

Wake Research enrolled more than 2,000 patients in the Novavax vaccine trial, and over 6,000 patients across multiple COVID vaccine trials including those by Moderna, Pfizer, and Johnson & Johnson.

"This accomplishment would not have been possible without the dedication of our staff who applied their experience and expertise to make sure quality data was collected and patients' safety was ensured at every step of the process," said Marieke Cajal-Berman, Director of Patient Engagement at Wake Research. "We were truly overwhelmed by the tremendous response from our community and the number of volunteers coming forward to help with this historic medical advancement."

"Studies are ongoing as more vaccines are still needed to have enough doses available for all, and to ensure immunity against new variants. We hope volunteers will continue to answer the call to action. We are all in this together, and we look forward to continuing to work together on these invaluable clinical research efforts."

Although the Novavax vaccine trials started in late December in the US, the Novavax COVID vaccine candidate already looks promising based on early results and international studies. Official results for U.S. trials are still pending. The U.K. trials showed the Novavax vaccine to be 89.3% effective in a trial of 15,000 participants. Due to its later start, the Novavax clinical trial likely included participants exposed to some of the newer coronavirus variants.

Physicians at Wake Research are optimistic about the Novavax COVID vaccine as well. Matthew Hong, MD, principal investigator of Wake Research in Raleigh, told local news outlet CBS-17 that the outlook is promising and that the Novavax vaccine is expected to get the FDA greenlight too.

The Novavax vaccine is a two-dose vaccine that does not utilize the same mRNA technology as the Moderna and Pfizer vaccines. Therefore, the Novavax COVID vaccine does not require ultra-cold storage, which should facilitate distribution once approved for emergency pandemic use. Additionally, the Novavax vaccine utilizes state-of-the-art technology that builds upon technology employed in traditional flu vaccines and other anti-virus vaccines, with an innovative advancement to target the coronavirus. The Novavax vaccine introduces a spike protein that triggers the human body's immune response so it is capable of fighting off the coronavirus' spike protein. Additionally, the Novavax vaccine contains a natural immunity booster derived from tree bark that boosts immunity up to 3-10 times more than the vaccine alone.

"Companies and governments around the world came together with scientists, physicians, and patients, working tirelessly to stop this pandemic, and we are honored to participate in ongoing efforts to stop the coronavirus," states Ella Grach, MD, chief executive officer of Wake Research. "We utilize a proven, highly effective multi-faceted approach to patient engagement, and we strive to continually improve upon our already successful system of resources, expertise, and strategies for optimum success in patient enrollment."

Wake Research Earns Additional Recognition as a Top CRO Service Provider

In addition to achieving the recognition as a Top Enroller by Novavax, Wake Research was featured by PharmaTech Outlook as a Top CRO Service Company of 2021. Each year, PharmaTech Outlook features "ten companies that are on the forefront of providing Contract Research Organization (CRO) consulting services and transforming businesses." Wake Research was recognized based on their efforts to end the global pandemic by providing innovative and integrated clinical research, and producing comprehensive clinical services and results, according to the overview in PharmaTech Outlook's March 2021 edition.

A number of COVID-related studies are currently enrolling patient volunteers for trials at Wake Research locations across the country. 

About Wake Research

M3-Wake Research is an organization of integrated investigational sites, committed to excellence, working closely with and meeting the needs of the biopharmaceutical, biotechnology, medical device and pharmaceutical industries. M3-Wake Research's 16 sites are fully equipped to meet the needs of sponsors and CROs in the conduct of Phase I-IV clinical trials in a large variety of indications.

M3-Wake Research is known for effectively combining strategic volunteer recruitment, rapid trial start-up and subject enrollment/retention with high quality clinical trial conduct, using standardized operating procedures and centralized marketing and advertising to ensure rapid subject enrollment. M3-Wake Research sites have conducted more than 7,000 research studies for hundreds of pharmaceutical and biotech sponsors and CROs. Wake Research's mission is to bring novel medications, biologics and device through clinical research to as many people as possible while providing unparalleled service and exceptional value to clinical trial partners and stakeholders.

About M3 Inc.

M3 Inc. operates in the US, Asia, and Europe with over 4 million physician members globally via its physician websites such as mdlinx.com, m3.com, research.m3.com, doctors.net.uk, medigate.net and medlive.cn. M3 Inc. is a publicly traded company on the Tokyo Stock Exchange (TYO:2413) with subsidiaries in major markets including USA, UK, Japan, S. Korea, and China. M3 Inc. provides services to healthcare and the life science industry. In addition to market research, these services include medical education, ethical drug promotion, clinical development, job recruitment, and clinic appointment services. M3 has offices in Tokyo, Washington D.C., Fort Washington, PA, Oxford, London, Beijing, and Seoul.