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CRO to provide comprehensive clinical research management and support
Rho, a contract research organization (CRO) providing clinical research services in both the commercial and federal market, has been awarded the renewal of their existing federal contract with the National Institute of Dental and Craniofacial Research (NIDCR). The NC-based CRO will provide clinical research operations and management support (CROMS) to the NIDCR and to NIDCR funded clinical research studies from study preparation and initiation through study completion and close-out.
The $4.2 million one year contract includes four one-year options with a total estimated ceiling of $21.9 million.
“We are excited to support NIDCR’s research divisions and continue building the infrastructure for groundbreaking studies of oral, dental and craniofacial diseases and disorders,” said Laura Helms Reece, Dr. P.H., Chief Executive Officer for Rho. “Rho’s expertise and resources will help assure top-notch study design and execution, data management, statistical analysis, and regulatory compliance.”
Dr. Nancy Yovetich and Ms. Cathie Snyder will continue their leadership roles on the renewed contract as the Principal Investigator and Program Director, respectively. Through the contract period, Rho will operate and maintain a state-of-the-art secure computer-based system for the collection, management, storage, and quality control of clinical data, for studies supported by NIDCR. Rho will provide study support services such as protocol development; study startup planning; clinical research-related training; quality management support; management of or consulting for study implementation; technical and administrative support; website design and maintenance; review and submission of regulatory documents for Investigational New Drug (IND) and Investigational Device Exemptions (IDE) applications; statistical analysis; and manuscript collaboration. Additionally, Rho will design, develop, implement, and maintain an Adverse Event/Serious Adverse Event (AE/SAE) reporting system that will constitute NIDCR’s Pharmacovigilance Program.
As the NIDCR-CROMS contractor since 2008, Rho has previously provided similar support for hundreds of NIDCR studies. For additional details about Rho’s CROMS program, visit www.rhoworld.com/rho/federal-research.
This project has been funded in whole or in part with Federal funds from the National Institute of Dental and Craniofacial Research (administered by the National Heart, Lung, and Blood Institute), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN268201400073C.
For more information about the National Institute of Dental and Craniofacial Research visit www.nidcr.nih.gov.