Chapel Hill, NC (September 9, 2015) – Rho, a contract research organization (CRO) providing clinical research services in both the commercial and federal market, has been awarded a new cooperative agreement to provide statistical and clinical coordinating services to the Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID). The NC-based CRO will provide these services for DAIT’s large clinical research consortia in the areas of asthma and allergic diseases, autoimmune diseases, and transplantation.
The largest federal contract in Rho’s 31-year history, the award is valued at approximately $16.5 million per year for seven years. Additionally, supplemental funds of approximately $6.8 million have been awarded for the first year.
“Rho is excited to be selected as DAIT’s Statistical and Clinical Coordinating Center to support the important work they are doing to help combat serious health concerns, such as asthma and allergies, autoimmune diseases, and transplantation,” said Russ Helms, Ph.D., Chief Executive Officer for Rho. “Rho’s expertise and resources will help assure top-notch operational support, statistical analysis, clinical data management and bioinformatics services.”
The program uses a multiple principal investigator (PI) structure. Five Rho employees are serving as PIs on this project, including: Ronald W. Helms, Ph.D., Chairman and overall PI; Karen Kesler, Ph.D., Senior Statistical Scientist and Leadership Group PI; Samuel Arbes, Jr., D.D.S., M.P.H., Ph.D., Senior Research Scientist and Group Leader for the Asthma and Allergic Diseases Group; David Ikle, Ph.D., Senior Statistical Scientist and Group Leader for the Transplantation Group; and Lynette Keyes-Elstein, DrPH, Senior Statistical Scientist and Group Leader for the Autoimmune Diseases Group. Additionally, day-to-day management will be provided by Michelle Walter, M.S., Senior Project Director.
The project combines services that were previously under six separate awards from DAIT – Rho held five of the previous awards. For additional details about Rho’s federal research expertise, visit www.rhoworld.com/rho/federal-research.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.