|
CITY OF HOPE, AN NCI-DESIGNATED COMPREHENSIVE CANCER
CENTER, GOES LIVE USING OMNICOMM’S FIRST IN
FUNCTIONALITY™, ELECTRONIC DATA CAPTURE (EDC) SOLUTION
TrialMaster™ v4 is used in a Phase I Single Agent Study of Pazopanib in Patients with
Advanced Malignancies and Varying Degrees of Liver Dysfunction
FT. LAUDERDALE, FL – May 22, 2008 – /MarketWire/ - OmniComm Systems, Inc.
(OTC Bulletin Board: OMCM.OB), a leader in integrated electronic data capture
solutions for clinical trials, today announced that City of Hope, a National Cancer
Institute (NCI)-designated comprehensive cancer center, has gone live using TrialMaster
for EDC in the first of many trials that will benefit from using a unique library of
National Cancer Institute (NCI) related reusable electronic case report forms (eCRFs)
developed by OmniComm and City of Hope. The trial, coordinated by City of Hope on
behalf of the California Cancer Consortium, will enroll between 72 and 132 patients and
will involve at least 17 participating centers, including international sites.
“We are all delighted to reach this important milestone,” said Jeff Longmate, Director of
the Biostatistics Department, City of Hope. “OmniComm and City of Hope have worked
together to meet the needs of the diverse constituencies involved in a cancer center
clinical trial, as well as the scientific needs of the trial.”
To facilitate this study, OmniComm and City of Hope have combined efforts to create
approximately 50 unique eCRFs. These reusable electronic case report forms fulfill the
Clinical Trial Monitoring Service (CTMS) reporting requirements of the NCI for this
trial. Further, these eCRFs leverage the common data elements from the National Cancer
Institute’s cancer Data Standards Repository (caDSR) while supporting standard Cancer
Therapy Evaluation Program (CTEP) guidelines for coding disease classifications,
adverse events and prior therapies. This collaborative effort has spawned several tangible
assets that can be readily employed for other oncology studies. They include a flexible
export utility that transforms standard TrialMaster XML exports to the data submission
requirements defined by CTMS. The library of eCRFs is encapsulated in a reusable visit
structure common to many Phase I oncology trials, along with a modifiable set of roles
and enrollment procedures. Both City of Hope and OmniComm will be openly
publishing these reusable assets to the cancer community for use by other institutions that
perform clinical trials using the TrialMaster solution.
“We are proud that City of Hope has chosen to leverage our TrialMaster solution to help
standardize and accelerate the search for new cancer treatments,” said Ken Light, Senior
Vice President of Professional Services for OmniComm Systems. “City of Hope has
been a great partner to work with and they have helped us to establish leading tools and
best practices in support of cancer research.”
City of Hope plans to proceed directly to building a second trial that leverages these
benefits and additional forms from the caDSR related specifically to Breast Cancer. This
second trial will utilize OmniComm’s Technology Transition model. City of Hope staff
will independently build and deploy the study-build while OmniComm provides the
infrastructure, hosting, coaching, quality assurance and support services.
About City of Hope
City of Hope is a leading research and treatment center for cancer, diabetes and other life-
threatening diseases. Designated as a Comprehensive Cancer Center, the highest honor
bestowed by the National Cancer Institute, and a founding member of the National
Comprehensive Cancer Network, City of Hope's research and treatment protocols
advance care throughout the nation. City of Hope is located in Duarte, Calif., just
northeast of Los Angeles, and is ranked as one of "America's Best Hospitals" in cancer
and urology by U.S.News & World Report. Founded in 1913, City of Hope is a pioneer
in the fields of bone marrow transplantation and genetics. For more information, visit
www.cityofhope.org.
About OmniComm
OmniComm Systems, Inc. (www.OmniComm.com) provides customer-driven Internet
solutions to pharmaceutical, biotechnology, research and medical device organizations
that conduct life changing clinical trial research. OmniComm’s growing base of satisfied
customers is a direct result of the company’s commitment to deliver products and
services that ensure ease of use, faster study build, ease of integration and better
performance. OmniComm’s client intuitive pricing model allows companies that range
from small to mid-size to large scale institutions to safely and efficiently capitalize on
their clinical research investments. OmniComm Systems, Inc. has corporate headquarters
in Ft. Lauderdale, Florida with offices in Bonn, Germany, Tula, Russia, California,
Maryland, New York, North Carolina and Texas.
Safe Harbor Disclaimer
Statements about OmniComm’s future expectations, including without limitation, future
revenues and earnings, plans and objectives for the future operations, future agreements,
future economic performance, operations and all other statements in this press release
other than historical facts are "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of
1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995.
OmniComm intends that such forward-looking statements be subject to the Safe Harbors
created thereby. Since these statements involve risks and uncertainties, including but not
limited to economic competitive, governmental, contractual and technological factors
affecting OmniComm’s operations, markets and profitability, actual results could differ
materially and adversely from the expected results.
CONTACT:
Lizanne Kelley
OmniComm Systems, Inc.
954-473-1254 Extension 283
lkelley@omnicomm.com
Back |
