City of Hope, an NCI-Designated Comprehensive Cancer Center, Goes Live Using OmniComm’s First in Functionality(TM), Electronic Data Capture (EDC) Solution
OmniComm Systems, Inc. (OTCBB: OMCM), 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.
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CONTACT: Lizanne Kelley OmniComm Systems, Inc. 954-473-1254 Extension 283 Email Contact
SOURCE: OmniComm Systems, Inc.