Ft. Lauderdale, Florida – August 29, 2005 - /MarketWire/ - OmniComm Systems, Inc. (OTC Bulletin Board: OMCM - News), one of the fastest growing companies in the EDC marketplace, announced today that it has released its TrialMaster Safety module. This new TrialMaster solution was developed for our clients in need of a flexible, scalable and affordable safety system to track, manage and communicate Adverse Events (AEs) and Serious Adverse Events (SAEs) through their clinical trial process and beyond.

As part of OmniComm’s clinical suite of clinical trial solutions, OmniComm offers Trial Master Safety as its Pharmacovigilance database. Linked to our TrialMaster EDC Solution, TrialMaster Safety accommodates both MedDRA dictionary and customized client dictionaries and is HIPAA and 21 CFR Part 11 compliant. 

TrialMaster Safety Capabilities

• Provides for the coding [MR1] and storing of SAE information either in a manually entered mode directly into a web-based form or automatically through event-driven information from a clinical study EDC System such as TrialMaster. The import module is vendor-independent and can be configured to accept other sources of SAE information other than that from a clinical study or OmniComm’s TrialMaster ;
• Provides automatic alerts when predefined trigger events occur with iCRF form included in notifications for easy viewing;
• Generates electronic Data Clarification Forms (DCFs) / queries to assist faster case closure;
• Generates client-requested reports, including investigator notification of expedited safety reports;
• Generates and pre-fills MEDWatch Forms for U.S. reporting or CIOMS form for reporting in the rest of the world;
• Allows electronic reporting of SUSARs and generates listing for annual safety reports in compliance with the European Union Clinical Trials Directive;
• Allows for optional use of TrialMaster ’s powerful Ad Hoc reporting tool that offers end-users the ability to develop custom analysis and reports. Ad Hoc can be integrated into the TrialMaster Safety application, providing a powerful data mining analysis tool for clinicians and or sponsors.  By providing this functionality, the end-user is able to query any data variable or group of data contained in the database and can generate and save custom reports, including charts and graphs, with little knowledge of the underlying databases; and
• Designed to allow additional operational modules to be added forwarding the future with minimal impact to existing data structures.

“We are very pleased and excited to offer this new TrialMaster solution to our existing and future clients and thank them for their input and encouragement”, said Cornelis Wit, President and CEO of OmniComm. “We especially appreciate those clients that have already signed up for this new solution to compliment their TrialMaster EDC system”.

“TrialMaster Safety is yet another example of how all my colleagues within OmniComm are committed to developing flexible, scalable and easy to use clinical trial solutions that are affordable”.

About OmniComm Systems, Inc.

OmniComm Systems, Inc. is one of the fastest growing companies in the EDC market place targeting its product TrialMaster to the pharmaceutical, medical device and biotechnology companies as well as CRO’s.  OmniComm’s growing base of satisfied customers is a direct result of OmniComm’s employee’s commitment to on-time, quality and within budget performance. 

The TrialMaster system, the core product of OmniComm, provides trial sponsors with a 21 CRF Part 11 compliant Internet-based data and trial management solution that greatly increases the efficiency, security and integrity of clinical research data and thus significantly reduces the time and expense involved in conducting clinical studies.

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.

For more info, please email info@omnicomm.com