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Back To Vidyya Internet-Based Clinical Trials For New Contraceptive Gel:

Potential Breakthrough To Prevent Spread Of Sexually Transmitted Diseases

OmniComm Systems, Inc. of Miami, Florida announced it is partnering with Optima Worldwide, Ltd., to launch US testing of a new vaginal gel for the potential prevention of pregnancy and the most common sexually transmitted diseases.

Surete Gel, which is already being sold in China as a vaginal disinfectant and contraceptive, is being tested as a potential preventative agent for most sexually transmitted diseases (STD), including HIV. The concept of an anti-microbial product that prevents infectious sexual diseases has long been awaited by experts at the World Health Organization and The National Institutes of Health as an important weapon in preventing the global STD and HIV epidemics.

OmniComm's Internet electronic data capture system, TrialMaster(TM) and its web portal for trial investigators and participants, WebIPA.com(TM), will manage long-term testing of Surete Gel worldwide.

"Our research technology could significantly reduce the time and costs of conducting testing of the drug worldwide," said Dr. David Ginsberg, CEO and President of OmniComm and internationally renowned clinical trial expert. "We are excited that Optima chose OmniComm to take charge of its clinical trials globally, including Phase I through Phase III and large-scale Phase IV clinical trials."

Optima CEO and President Stephen Drake, is hailing the partnership with OmniComm as a big step forward. "We are very pleased with this alliance as we complete trials on Surete Gel. This brings us closer to bringing a microbicide gel to the important US market while our vaginal disinfectant and contraceptive is already being introduced abroad." Optima, an international, company, is awaiting approval to sell Surete Gel in India and Thailand, as well as in several African and European nations.

OmniComm is expanding its trial investigator base for Surete clinical trials in the US by enrolling experienced US investigators in the field of gynecology. A number of trial participants will be needed to take part in extensive testing before the product can be considered for approval in the US as more than a contraceptive. Surete complies with the FDA monograph as a contraceptive.

Anyone interested in taking part in those clinical trials -- investigators or participants -- must register thru OmniComm's web portal, WebIPA.com.

The TrialMaster system provides the pharmaceutical/medical device companies with an Internet-based solution which greatly increases the efficiency, security and integrity of the clinical trial process while drastically reducing the time and expense of conducting a trial. OmniComm provides not only the application, but also the physical infrastructure and networking design capabilities important to maintaining an Internet application. WebIPA provides the interface between patients, doctors and the clinical trial industry. It enables patients and physicians to interact and to investigate the various opportunities to participate in clinical trials. WebIPA also allows the clinical research industry the ability to interface with patients and doctors, expanding the critical population of trial participants and providing an invaluable research database.


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Editor: Susan K. Boyer, RN
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