COVID-19 Research Milestones
In January 2020, the U.S. sees its first case of the disease later named COVID-19 and declares a public health emergency. By March, the WHO declares COVID-19 a global pandemic. Travel bans and stay-at-home orders begin.
As research programs progressed, Brandon Essink, MD, CPI, Medical Director at Meridian, and Paul Bradley, MD, Principal Investigator at Meridian in Savannah, GA, joined weekly meetings with vaccine developers participating in the Operation Warp Speed (OWS) program and collaborating with the National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA). These calls helped guide protocol design for multiple sponsors.
Meridian was the first site to gain IBC approval for a large Phase 3 COVID-19 vaccine trial, and the company’s eight sites were also among the first 15 to gain approval for the study, which involved almost 100 sites.
As Phase 3 trials progressed, several Meridian Primary Investigators and leadership team members were quoted by major news outlets. Dr. Shishir Khetan, Meridian Principal Investigator in Rockville, MD, is quoted in a Washington Post article about the challenges of conducting clinical research during a global pandemic and the misconceptions that circulate among the general public. Brandon Essink, MD, CPI, Medical Director at Meridian, is quoted by NBC News, and Dr. Asefa Mekonnen, Meridian Principal Investigator in Savannah, GA, is quoted by both ABC News and The Savannah Tribune, both doctors discussing the importance of diversity in clinical research.
As vaccine trials became the industry’s priority and entered the public spotlight, Meridian won the 2020 Vaccine Industry Excellence (ViE) awards for Best Clinical Trial Site and Best Clinical Trial Network.
“Winning the ViE awards reaffirmed the quality of work our investigators and staff put forward every day, and the trust established with leading vaccine developers.”
Nicole Osborn • Founder and CEO, Meridian
In early November, Moderna completed enrollment of its Phase 3 trial for mRNA-1273, in which Meridian enrolled more than 2,750 participants, bringing the total number of COVID-19 clinical trial participants at Meridian to more than 3,500 by the end of November.
2021 & Beyond
By December of 2021, Meridian reaches 10,000 COVID-19 clinical trial randomizations and continues to enroll patients into COVID-19 trials, including studies for booster and variant vaccines, treatments and diagnostics. Thank you to the incredible people who have supported the vaccine studies, as well as COVID-19 medication, diagnostic, and observation studies at Meridian and beyond.
COVID-19 Clinical Trial Recruitment and Retention
Advertising & Public Relations
Meridian directed recruitment advertising and public relations activities that generated more than 60,000 new, fully-identified potential participant leads in less than a year. More than half of the 10,000 patients Meridian has enrolled into COVID-19 trials were attained through in-house advertising and media outreach. Additional interested participants were reached through the NIH CoVPN Volunteer Screening Registry.
Participant Screening & Scheduling
Given the volume of interest, Meridian developed a unique screening process to triage qualified participants for particular studies. “We were able to enroll patients into trials that best supported Sponsors,” said Beau Garland, Vice President of Recruitment at Meridian. “For Phase 3 trials, we helped Sponsors achieve proportionate ethnic diversity and enroll patients with certain pre-existing conditions. We wanted to go beyond the minimum inclusion/exclusion criteria to find the right patients.”
Meridian partnered with StudyKik in June 2020 to screen the influx of potential participants interested in vaccine studies. In less than four months, StudyKik helped Meridian call and screen almost 22,000 potential participants who requested information about COVID-19 vaccine trials. At peak times, Meridian and StudyKik call centers processed a combined 2,000+ leads per week.
“Working with Meridian on this project was a phenomenal experience. We couldn’t have asked for a better partner to work with patients and make an impact on bringing a COVID-19 vaccine to the world,” said Sam Haiden, Chief Strategy Officer at StudyKik. “As always, their staff was responsive, attentive, and professional. Given the unique challenges that this pandemic has presented, both StudyKIK and Meridian had to rapidly solve new challenges to support these trials.”
“StudyKIK has been a valuable partner for Meridian since 2014,” said Osborn. “They were our first call when we needed to screen that volume of patients quickly and accurately — we knew they’d deliver a made-to-match solution.”
In October 2020, Meridian opened a new call center and dedicated research center in Sioux City, IA. This call center, along with Meridian’s fully-owned and -operated call centers in Omaha, NE, and Statesboro, GA, supported screening, scheduling, and follow-up activities.
Meridian also developed a novel retention program to support several COVID-19 vaccine studies. The program provided participants with a unique item at each in-person visit. Additionally, Meridian hired specialized call center staff focused on patient retention and engagement to ensure trial completion and full adherence with diary, visit, and safety calls.
Infrastructure and Clinical Operations
Meridian has conducted COVID-19 clinical trials at ten sites nationwide. To accommodate high-volume trials and spikes in COVID-19 vaccine trial interest, Meridian introduced a traveling vaccine team, increased staffing, and extended office hours to see patients seven days a week at all high volume sites.
Where possible, Meridian expanded into secondary clinical spaces to accommodate sick visits. Where space was constrained, sites improvised. “We used electronic buzzers like you find in restaurants,” said Laura Falcone, COO of Meridian. “This was helpful for queuing patients — we could check them in while they stayed in our parking lots.”
All Meridian sites used call-in parking lot waiting and extended scheduling to moderate site traffic and allow for intensive cleaning between visits.
Meridian more than doubled its clinical and operational staff companywide in 2020. All new clinical staff underwent a comprehensive training program that included compliance (e.g., ICH-GCP, TransCelerate, IATA, OSHA) and Meridian-specific courses.
Compliance, Quality Assurance, and Audit Support
In 2019, Meridian made significant investments to centralize regulatory processes on a web-based platform. That move expedited Sponsor, CRO, and PI review, and enabled immediate, secure access for remote monitoring companywide. “In years prior, we also ensured sites had HD videoconferencing capabilities, and we had been honing processes to cut data entry timelines to within an hour or two of patient visits to give Sponsors and CROs data in near real-time,” said Osborn. “In a world suddenly dependent on virtual workflows we had the tools in place to scale up immediately for high-volume COVID-19 trials.”
As a leading enroller for the Moderna, Pfizer/BioNTech, and Novavax trials, Meridian’s dedicated quality assurance staff cut data entry timelines to within two hours of patient visits, enabling Sponsors/CROs to receive data in near real-time (the industry standard for data entry is typically 48-72 hours post visit). All sites also supported remote monitoring visits.
To support trials involving genetically engineered vaccines, Meridian partnered with Advarra to streamline Institutional Biosafety Committee (IBC) review and oversight. Eight Meridian sites operated with harmonized standard operating procedures (SOPs), which resulted in an average four-day turnaround time for approvals. Meridian was the first site to gain IBC approval for a large Phase 3 COVID-19 vaccine trial, and the company’s eight sites were also among the first 15 to gain approval for the study, which involved almost 100 sites.