TUESDAY, JUNE 19, 2018

Romark partners with DSG for trial of investigational influenza treatment

Romark Laboratories recently announced that it will conduct a Phase III clinical trial of its investigational influenza treatment Nitazoxanide, also known as NT-300, with help from DSG, Inc.

Romark will use DSG's eCaseLink software, an electronic database, as well as its Interactive Web Response System to create systematic randomization and dosage control for the study. The trial will involve 1,540 outpatient participants experiencing simple, acute influenza infection. The study is expected to produce an oral influenza treatment for both pandemic and seasonal strains.

"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," Romark Laboratories CEO Marc Ayers said. "DSG's experience and flexibility to meet our requirements ensures our study can run quickly, accurately and within our budget."

The final development of NT-300 was made possible through a $46 million contract through the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority. Romark began work under the contract immediately and the clinical study will observe the safety and efficacy of NT-300, NT-300 with Tamiflu and Tamiflu alone compared against a placebo.

"Romark's work is groundbreaking for the treatment of influenza, as shown by their contract with HHS and partnering with BARDA," DSG CEO Tony Varano said. "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."