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As influenza continues to lead to more than 226,000 hospitalizations and 24,000 deaths annually in the United States alone, new treatments are critical for fighting the latest strains of the virus. To combat this seasonal issue, Romark Laboratories will complete the advanced development of Nitazoxanide (NT-300) as a treatment for acute uncomplicated influenza in a Phase III clinical study using the integrated eClinical products and services from DSG.
DSG’s role is critical for this study of 1,540 outpatient subjects experiencing acute uncomplicated influenza and the findings could lead to both a seasonal and pandemic oral medication for the virus. Romark is taking advantage of DSG’s electronic data capture software, eCaseLink™ as well as using its Interactive Web Response System (IWRS) for randomization and dosage control at sites. They are also using DSG’s Site Payment Module and Central Lab Integrator - all of which will ensure greater accuracy of subject findings and allow Romark to move quickly through the study.
“We looked at a variety of solutions, but the fact that DSG offered Romark an integrated, one-stop shop for our needs, all of which are extremely user-friendly and intuitive for site users made the difference,” said Marc Ayers, CEO of Romark Laboratories. “DSG’s experience and flexibility to meet our requirements ensures our study can run quickly, accurately and within our budget.”
Romark was recently awarded a $46 million contract with the U.S. Department of Health and Human Services for completion of clinical development of NT-300 and the contract is administered through the Biomedical Advanced Research and Development Authority (BARDA), an agency that supports advanced development of the countermeasures for the latest health threats. Romark is beginning work under the contract immediately and the study will evaluate the efficacy and safety of NT-300 or NT-300 plus Tamiflu® compared to a placebo or to Tamiflu alone.
“Romark’s work is groundbreaking for the treatment of influenza as shown by their contract with HHS and partnering with BARDA,” said Tony Varano, CEO of DSG. “DSG is pleased to offer its EDC, IWRS and Data Management products and services to fight this deadly virus that affects more and more citizens every year.”