ClinicalRM signs contract with NIH to provide broad spectrum of services for STI CTG Program

Clinical Research Management, Inc. (ClinicalRM) – a full-service Contract Research Organization (CRO) providing services for basic and applied research, clinical trials, and regulatory support – announced today it was awarded a contract by the Department of Health and Human Services, National Institutes of Health, Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID). The intent of the award is to provide a broad spectrum of services for the design and conduct of Phase I-IV clinical trials and clinical studies focused on the screening, diagnosis, treatment, prevention, and control of Sexually Transmitted Infections within the Sexually Transmitted Infections Clinical Trials Group (STI CTG) Program.

ClinicalRM has partnered with Johns Hopkins University (JHU) and is one of only three other companies to be awarded this contract. 100% of the total costs of the program will be financed with Federal money.  The contract ceiling for the 7-year STI CTG Program for all awardees is $70 M. The STI CTG contract is an Indefinite Delivery/Indefinite Quantity (ID/IQ) contract.

"This award gives us an opportunity to test the effectiveness of several new - and older - medications to treat and prevent STIs," said Dr. Mac Griffiss, Principal Investigator on the contract. "It comes at a time when many of the causes of these infections are becoming increasingly resistant to current antibiotics. We have protocols that are ready to be implemented, and we are excited at the prospect of improving the outcome of these infections."

Dr. Jonathan Zenilman, a Central Investigator on the contract from JHU, stated, "The recent STI contract award builds tremendously on our groups' experience and strengths.  ClinicalRM, Case Western Reserve University, and JHU have been enormously successful in the Phase I infectious disease programs.  The STI CTG allows us to integrate our clinical expertise in STI/HIV research and provide a seamless Phase I-III path for new STI treatments."

The mission of the Program is to foster, develop, and administer a research program that will contribute to human reproductive health and specifically lead to the prevention and control of STIs. The broad public health goals of this research program focus on the prevention of (i) STIs and associated syndromes; (ii) infertility; (iii) adverse outcomes of pregnancy, including preterm birth and low birth weight; (iv) reproductive tract neoplasia; and (v) other chronic STI sequelae.

Victoria Tifft, CEO of ClinicalRM, stated, "ClinicalRM is proud to engage in this critical work with NIAID and JHU. The award of this contract allows us to continue to build strong and meaningful partnerships with the Government, industry, and academia to combat a variety of infectious diseases."