DSG's suite of eClinical solutions chosen for Phase III study of new treatments for acute uncomplicated influenza.
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.”
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.