|[March 11, 2014]
Romark Laboratories Selects DSG for Influenza Study
MALVERN, Pa. --(Business Wire)--
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 mee 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."
About Romark Laboratories
Romark Laboratories, L.C. is a biopharmaceutical company committed to
the discovery and development of innovative small molecule drugs for
treating infectious diseases and cancers. The company is developing a
new class of broad-spectrum antiviral drugs called thiazolides. Romark
markets Alinia® (nitazoxanide) tablets, 500 mg and Alinia®
(nitazoxanide) for Oral Suspension, 100 mg/5 mL in the United States.
DSG, Inc. supports clinical trial data collection and management with
innovative technology solutions, including Electronic Data Capture with
specialized Clinical Data Management services, IWRS, Safety database,
Clinical Trial Management Systems and digital on-demand Case Report Form
publishing management software. DSG's products allow user-friendly,
accurate and efficient data capture at any investigator site regardless
of the technological infrastructure. DSG has successfully supported
thousands of clinical trials for more than 400 companies at over 25,000
sites in more than 90 countries. Founded in 1992, DSG is a global
company headquartered in Malvern, Pa., with additional offices in the
U.S., Japan and India. For more information, please visit www.dsg-us.com.
All products and services mentioned in this announcement are the
property of their respective owners.
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