Rho, a Chapel Hill, N.C.-based CRO, has renewed an existing federal contract with the National Institute of Dental and Craniofacial Research (NIDCR), a part of the Health and Human Services and NIH. Rho will provide clinical research operations and management support 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.

Dr. Nancy Yovetich and Cathie Snyder will continue their leadership roles on the renewed contract as the Principal Investigator and program director, respectively.

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; web site 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.