Contract Research Organization Emmes Comes Through on Critical Phase 1 COVID-19 Vaccine Trial

Contract Research Organization Emmes Comes Through on Critical Phase 1 COVID-19 Vaccine Trial

Since 1977, contract research organization (CRO) Emmes has consistently participated in important studies contributing to important drug development initiatives in the United States and beyond. Most recently, the mid-sized CRO, with about 600 professionals, touted its recent participation in the data and statistical analysis support for the critically important Phase 1 clinical trial of the investigational COVID-19 vaccine mRNA-1273. One of the mRNA-based vaccine candidates, Emmes’ employees helped co-author the Preliminary Report about the clinical trial “An mRNA Vaccine against SARS-CoV-2.” Emmes came through on this study and other sponsors should know about this vendor, committed to high impact and high-quality delivery.

Ultimately published in the New England Journal of Medicine on July 14, 2020, three Emmes employees participated as co-authors supporting this important vaccine study. These authors included Jim Albert, who served as leading project manager; Dr. Mat Makowski, senior biostatistician; and Kaitlyn Cross, senior biostatistician. The mid-market CRO set up the electronic data capture system in about a month, reported Jim Albert, noting, “Our team was driven to do everything we could to contribute to this critical human challenge.”

The Vaccine Candidate

mRNA-1273 was developed by Moderna in partnership with the National Institutes of Allergy and Infectious Diseases, led by Dr. Anthony Fauci. Emmes was selected as the CRO to provide the statistical and data collection and coordination center, development of the statistical analysis plan, and, of course, the actual execution of the data analysis.

The Study

This Phase 1 clinical trial started back in March 2020 in a bid to investigate the safety of the mRNA-1273 vaccine and its ability to induce an immune response to SARS-CoV-2. An open-label clinical trial, the sponsors recruited 45 healthy adult volunteers, ages 18 to 55, who received two vaccinations, 28 days apart. This study resulted in anti-SARS-CoV-2 immune responses in all participants, and there were no trial-limiting safety concerns raised during the study.

The CEO POV

Dr. Anne Lindblad serves Emmes as president and chief executive officer. After earning her PhD in Statistics from George Washington University, Ms. Lindblad joined the company in 1982 when it had only 15 employees after a friend from graduate school, Don Stablein, convinced her to join. The rest is history as they went on to build a solid, mid-market CRO contender. 

Dr. Lindblad recently commented on the experience of the study, “It has been a privilege to collaborate with Moderna and with NIAID in developing a vaccine for COVID-19.” She continued, “The successful Phase 1 trial has paved the way for the subsequent clinical trials.”

Emmes

A leading CRO serving the public and private sector, Emmes collaborates with clients to produce valued, trusted, scientific research. The company has evolved a culture that develops passion and conviction to make a difference in the world of research and drug development. The company has supported more than a thousand studies across a diverse range of diseases since its founding. They position that their research contributes to a healthy world, and they clearly delivered quality services for the most recent COVID-19 vaccine study highlighted here. Emmes employs at least 600 professionals, making it a good-sized, mid-market CRO capable of engaging large pharmaceutical studies.

Call to Action: For comprehensive support for clinical trials, sponsors should consider Emmes. See their contact information.

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