8-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): May 6, 2008

OMNICOMM SYSTEMS, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

(State or Other Jurisdiction of Incorporation)

000-50839	11-3349762
(Commission File Number)	(IRS Employer Identification No.)

2101 W. Commercial Blvd. Suite 4000, Ft. Lauderdale, FL	33331
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (954) 473-1254

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01 Regulation FD Disclosure.

On May 6, 2008 OmniComm Systems, Inc., presented at the AeA Micro Cap Financial Conference in Monterey, California. Background, financial and strategic information about OmniComm System, Inc. is included in the power point presentation and is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in the PowerPoint presentation attached hereto is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that Section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	OmniComm Systems, Inc. PowerPoint presentation for the AeA Micro Cap Financial Conference on May 6, 2008.

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

	OmniComm Systems, Inc.
May 6, 2008	By:	/s/ Ronald T. Linares
		Ronald T. Linares
		Chief Financial Officer

3

Exhibit Index

Exhibit Number	Description
99.1	OmniComm Systems, Inc. PowerPoint presentation for the AeA Micro Cap Financial Conference on May 6, 2008.

4

EX-99.1

10

th

Annual AeA Micro Cap

Financial Conference

May 6, 2008

OmniComm Systems, Inc.

(OMCM)

Exhibit 99.1

Page 2

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OmniComm Systems, Inc.

NOTICE REGARDING

FORWARD LOOKING STATEMENTS

Statements contained in this presentation, which are not historical facts, such as

statements about prospective earnings, savings, revenues, operations, revenue and

earnings growth and other financial results are forward-looking statements pursuant to the 

safe harbor provisions of  the Securities Litigation Reform Act of 1995. All  such

forward-looking  statements including the statements contained herein regarding

anticipated trends in the Company’s business are based  largely on management’s

expectations and are subject to and qualified by risks and uncertainties that could  cause

actual results to differ materially from those expressed or  implied by such statements. 

These risks and uncertainties include, without limitation, competitive factors, outsourcing

trends in the pharmaceutical industry,  levels of industry research and development

spending, the rate of adoption of EDC solutions by clinical trial sponsors, the Company’s

ability to continue to  attract and retain qualified personnel, the loss of any significant

clients, the Company’s ability to increase contract volumes, the Company’s ability to

raise capital at on favorable terms or without detrimental effect, and other factors

described in the Company’s filings with the Securities and Exchange Commission

including its Annual Report on Form 10-KSB and Quarterly Reports on Form 10-QSB. 

The Company undertakes no duty to update any forward  looking statement to conform

the statement to actual results or changes in the Company’s expectations.

Page 3

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OmniComm Systems, Inc.

Company Profile

OmniComm Systems is an eClinical software

and services company dedicated to helping the

world’s leading pharmaceutical, biotechnology,

medical device and research organizations

maximize the value of their clinical research

investments through the use of innovative and

cutting edge technologies.

OmniComm’s software application,

TrialMaster v4.0, automates the traditionally

inefficient paper-based approach to capturing

and processing clinical trial data by allowing

for web-based Electronic Data Capture (EDC).

Page 4

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OmniComm Systems, Inc.

Traditional Paper-Based Clinical Trial

-1-

-

Clinical Study is defined

-

Paper CRFs are printed

-

3 -

-

Patients enter study

-

Doctor fills patient

chart (source doc)

-

4 -

-

Data is transcribed

from source doc to

patient CRFs

-

6 -

-

Data entry is performed

by trained data entry

staff

Sponsor Company

Clinical

Database

Paper

CRFs

Site 3

Site 2

Site 1

-

2 -

-

Paper CRFs are

shipped to all sites

-

5 -

-

Completed CRFs

are verified and

shipped to sponsor

-

7 -

-

Data errors are detected

-

Sponsors query sites

for data clarifications

-

8 -

-

Cycle of data collection and

clarification repeated to end of study

Data

Data

Collection

Collection

Cycle

Cycle

Page 5

First in Functionality

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OmniComm Systems, Inc.

OMCM’s

TrialMaster

Improved Process Using Electronic

Data Capture

Central

Clinical DB

Data Entry

Sites

Enter and Validate

over the Web

1

Define Study

2

Validate Centrally

3

Resolve discrepancies over the Web

4

Page 6

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OmniComm Systems, Inc.

EDC Adoption and Growth

Source: 2007 Health Industry Insights Report

Spending on EDC solutions is expected

to increase at a 14.7% CAGR and total

more than $3.1B for 2006 -2011.

60% of all new clinical trials (Phases I-

III) are expected to use EDC in 2008.

Page 7

First in Functionality

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OmniComm Systems, Inc.

eClinical Market Adoption Rate (U.S. only)

$1.8B

$1.5B

$1.2B

$900M

$600MM

$500MM

eClinical Total

Market

(3)

9,000

7,500

6,000

4,500

3,000

2,500

# of Trials Using

EDC

(2)

90%

75%

60%

45%

30%

25%

eClinical

Adoption Rate

(1)

2010

2009

2008

2007

2006

2005

(1)

Health Industry Insights, 2007

(2)

Clinicaltrials.gov –

assumes 10,000 trials per year in U.S.

(3)

Assumes $200,000 in eClinical trial spending

FDA is pushing for increased regulation in the clinical trial process

FDA deadlines for electronic submissions are likely in near term

FDA may require post-approval studies for post-market drug safety

Page 8

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OmniComm Systems, Inc.

OMNICOMM CORPORATE OVERVIEW

(OTCBB: OMCM)

•

Company commenced EDC operations in February 1999

•

85 employees today

•

Headquartered in Ft. Lauderdale with offices in Germany and Russia

•

TrialMaster

™

is

OMCM’s

proprietary

EDC

platform

•

Version 4.0 released early 2007

•

OC Connect (Oracle Bridge) released June 2007

•

TrialMaster is now available under both an ASP and Technology Transfer

models

•

OmniComm

has

run

over

200

clinical

trials

across

every

continent

with over

80 customers

•

Client and contract base is growing rapidly

•

Company

has

attracted

top

experienced

sales

reps

from

well

known

EDC

competitors

Page 9

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OmniComm Systems, Inc.

EDC Drives Clinical Trial Improvements

Clinical

Trials

–

crucial

to

success

in

R&D

for

Life

Sciences

organizations

EDC is a classic disruptive technology and the market is poised for explosive growth

Health Industry Insights predicts that at the end of 2007 approximately 45% of all new

clinical trials used EDC and that that number will grow to over 80% in next 3 years

Principle Benefits of EDC:

•

Reduces clinical development timelines

•

Reduces costs of running clinical trials

•

Increased visibility enables faster go/no-go decisions

FDA is pushing for increased regulation in the clinical trial process

•

FDA deadlines for electronic submissions are likely in near term

•

FDA may require post-approval studies to monitor post-market drug safety

Opportunity exists for a competitively advantaged firm to capture the

growing market share of EDC products and services

Page 10

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OmniComm Systems, Inc.

Full Coverage Across Entire

eClinical Spectrum

EDC

ePRO

Imaging

Safety,

Handling

IVR

eProtocol

Design

Coding

Page 11

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OmniComm Systems, Inc.

OmniComm’s EDC Platform –

TrialMaster

®

Track Adverse

Events

Improve Trial

Administration

Enforce Consistent

Worldwide Standards

Capture Clinical Data

from Investigative Sites

Coordinate with

Partners

•

Integrate safety and other trial data to manage

compliance or handle spontaneous events

•

Integrate safety and other trial data to manage

compliance or handle spontaneous events

•

Give all personnel access to real-time information

•

Handle additional workload with fewer people

•

Give all personnel access to real-time information

•

Handle additional workload with fewer people

•

Setup studies rapidly

•

Exchange data more easily across disparate

clinical systems

•

Setup studies rapidly

•

Exchange data more easily across disparate

clinical systems

•

Reduce delays and errors associated with paper

•

Centralize all data to increase availability

•

Reduce delays and errors associated with paper

•

Centralize all data to increase availability

•

Import and assimilate CRO data

•

Import and assimilate CRO data

Key Benefits

Capability

Page 12

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OmniComm Systems, Inc.

Competitive Advantages

Flexible

Connectivity

Clinical

Experience

Unparalleled

Customer

Service

Accelerating

Momentum

Robust

Features

Cost

Competitive

Position

•

Flexible

EDC

Solution

offers

multiple

platform

support

(Oracle,

SQL)

•

In addition to our experienced management team, our employees bring

years of clinical expertise-

last 15 hires have over 160 years experience

•

OmniComm

may

be

a

software

company,

but

our

value-add

comes

from the continually high level of customer service that exceeds

expectations

•

Each successful engagement opens the door for further clinical trial

penetration. As new customers complete Phase I trials, we are

experiencing increased repeat business for Phases II -

IV

•

Our on-demand system provides immediate access to all clinical data.

Enhanced functions include medical coding, inventory management,

safety, CTMS and other features not typical in most EDC systems.

•

Due to our innovative Trial Design tool, OMCM operates at higher

gross

margins

than

our

competition,

allowing

us

to

pass

on

a

competitive price to our customers.

Page 13

First in Functionality

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OmniComm Systems, Inc.

Scalable Business Model

•OMCM Offers EDC under a “Crawl, Walk, Run”

Basis

•Three Business Models Provides Opportunity to Service Broader Scope of the

Clinical Trial Industry

Applicable for larger

customers that will internally

host all data and design the

initial study build:

Designed to allow client to

bring study Admin and Set-

up services in-house, yet

continue to host critical data

with OmniComm:

Provides turnkey EDC

application, with a fully

hosted system on

OmniComm’s servers:

Application Service

Provider (“ASP”)

Technology   

Transfer

Technology

Transition

Initial Study Build

Hosting

Maintenance

Rev. recognized ratably

over life of trial

On-Site Training

Cooperatively built study

program

Hosting

Maintenance

Implementation

Training and support

Project consulting

Page 14

First in Functionality

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OmniComm Systems, Inc.

OmniComm’s Milestones

1999

–

OmniComm Systems, Inc. formed as a post-merger entity in February 1999; headquartered in Ft.

Lauderdale, Florida

2000

–

TrialMaster Version 2.0 released

2002 –

TrialMaster Version 3.0 released

2004

–

Phase I specific TrialMaster product developed for improved productivity,

responsiveness, data accuracy and reduced trial time

2005

–

TrialMaster Archive module is developed to allow sponsors to view all trial

data in its originally captured format

2006

–

OmniComm opens European Office and begins ramping up

2007

–

Version 4.0 released

Integration success stories w/ Oracle

Clinical,

SAS,

CDISC,

HL7,

PHT’s

LogPad™

and

FastTrack

Systems, Inc. TrialSpace Designer™

1H’08

–

Over $3 MM in contracts are booked in Q1, representing an

increase in bookings of 40% from Q1 last year

$1.5 MM 

Enterprise Transaction

Page 15

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OmniComm Systems, Inc.

Strategic Focus

•

OmniComm’s strategy has been to focus on the underserved small to

medium trial sponsor market

•

New capabilities and technology has now allowed us to support the larger

pharma & CRO market as well

–

Global Operations/Support

–

Integration with Oracle Clinical

•

CRO Partnership Program extends Business Development presence

•

Expanded Business Model allows OMCM to generate ASP/Hosted Services &

Technology Transfer Revenue

•

Entry at earlier phases (I and II) increases potential for larger Phase III and

IV trials

–

New technology gives OMCM an edge in Phase I trials

–

Partnership with Logos (Phase I data capture solution)

•

Continue expansion into the European trial market

Page 16

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OmniComm Systems, Inc.

Recent Highlights

2

10

Medical

Device

388K

185K

Average

Deal

Size in $

2

0

4

2

8

3.1

Q1 Fiscal

2008

5

19

13

8

55

10.2

Fiscal 2007

Academic

& Other

CRO

Bio-

Tech

Pharma

# of

New

Trials

Contract

$ in MM’s

We entered into 18 CRO Partnership Agreements in Fiscal 2007 and

4 Agreements Year-to-Date in Fiscal 2008

Page 17

First in Functionality

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OmniComm Systems, Inc.

Recent Highlights

Major Highlights

Valeant Pharmaceuticals

Chooses OmniComm over 6 Competing EDC Companies

due to clear distinction in services and support

Major West Coast Biopharmaceutical Company

5 year, 1.5 million Enterprise

Finalist in the National Cancer Institute’s (NCI) EDC Evaluation

OMCM partners with Logos Technologies to create an integrated solution with

ALPHADAS®, the premier electronic data capture solution designed specifically for

Phase I clinical trials

Page 18

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OmniComm Systems, Inc.

Experienced Management Team –

110 Years

All OMCM

8

Ronald Linares

CFO

Organon, Duphar (Solvay), DMV

41

Cornelis Wit,

President & CEO

Industry Related Experience

110 Years of

Experience

All OMCM

9

Randall Smith

Chairman & CTO

Oracle, PHT Corp, Clinical Data Solutions,

Pfizer

17

Stephen Johnson

COO

Eli Lilly, Johnson & Johnson, Sanofi, Kos

Pharma

15

Sondra Smyrnios

SVP Clinical Operations

Oracle, Business Edge Solutions,

First Consulting Group

20

Ken Light

SVP Professional Services

Financial Overview

Ron Linares, Chief Financial Officer

Page 20

First in Functionality

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OmniComm Systems, Inc.

Long-term Growth Strategy

Engage smaller Phase I contracts; secure Follow-on

Unveil TrialMaster v4

Leverage for larger Phase II, III contracts

Emphasize Clinical expertise and ease of integration with industry partners

Expand Profitable     

Growth

Further Penetrate 

Customer Base

Build a Competitive 

Position

Int’l Expansion; Acquisition

Secure Short-term Clients

Penetrate Fortune 100 Sponsors via Licensing Model

Growth Phases

Page 21

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OmniComm Systems, Inc.

Financial Highlights, FY’07

0

5000

10000

15000

20000

25000

30000

35000

40000

45000

Dec-06

Mar-07

Jun-07

Sep-07

Dec-07

Mar-08

Total Pipeline

Probability Adjusted

Sales

Pipeline

2006

–

Q1 2008

In MM’s

Page 22

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OmniComm Systems, Inc.

Summarized Operations

% of

% of

2007

Revenues

2006

Revenues

Total revenues

3,723,841

$           

2,763,039

$   

Cost of sales

1,033,824

27.8%

969,323

35.1%

Gross margin

2,690,017

72.2%

1,793,716

64.9%

Salaries, benefits and related taxes

5,886,663

158.1%

3,986,311

144.3%

Total Operating Expenses

7,906,033

212.3%

5,525,422

200.0%

Operating Loss

(5,216,015)

$          

(3,731,706)

$  

G & A Investments

Clinical Personnel

487,904

100,404

Professional Services Personnel

148,729

0

Recruiting Fees

212,514

376,152

European Operations

329,368

191,300

R & D

917,000

742,000

FAS 123 Option Expense

980,823

786,703

3,076,338

2,196,559

Deferred Revenues

2,632,274

1,643,566

For the years ended December 31,

Page 23

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OmniComm Systems, Inc.

Revenue

Segmentation

–

by

Client

Type

18%

31%

22%

18%

11%

Pharmaceutical

Bio-Tech

Medical Device

CRO

Academic & Other

Page 24

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OmniComm Systems, Inc.

Contract Growth

$0

$750,000

$1,500,000

$2,250,000

$3,000,000

$3,750,000

Page 25

First in Functionality

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OmniComm Systems, Inc.

Average

Trial

Size

–

by

Trial

Phase

N/A

159,707

N/A

Phase IV

536,324

277,638

222,691

Phase III

530,172

133,917

156,939

Phase II

92,469

96,102

77,686

Phase I

2008

2007

2006

Realizing pricing power in Fiscal 2008 in Phase II and Phase III

segment

of the clinical trial market

Page 26

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OmniComm Systems, Inc.

Capital Structure, Cash and Sustainability

OTC Bulletin Board:

OMCM

Stock Price:

$0.54

52 Week Range:

$0.71 -

$0.48

Market Cap:

$40MM

Fully Diluted Market Cap:

$54MM

Common Stock

74,701,008

Series A Preferred Stock

2,810,149

(1)

Secured Convertible Debt

3,977,563 

(2)

Warrants & Options

17,925,890

(3)

99,414,610

(1)

Assumes conversion at $1.50/share.

(2)

Assumes conversion at $0.595/share.

(3)

Exercise price of Warrants and Options range from $0.25 to $0.75

per share.

Page 27

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OmniComm Systems, Inc.

Capital Relationships

Closed Secured Convertible Debt round of financing on 2/29/08

•

$2.25 MM Convertible at $0.595/share

•

75% Warrant Coverage at $0.75/share

Strong Existing Relationship with Noesis Capital

•

Boca Raton, FL based Placement Agent & Money Management

Firm

•

Funding of Approximately $16.5 in Debt and Equity since 1999

Page 28

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OmniComm Systems, Inc.

Investment Highlights

•

Company culture focused on providing the best Customer

Service separates OmniComm from its peers and creates

substantial value

•

Invaluable to the customization process of working with

customers and anticipating problem areas for EDC

implementation

•

Innovative and Customizable EDC Product within an

aggressively growing market

•

Compiled team with extensive industry knowledge, including

top sales reps from well-known software, healthcare and

competing EDC firms

•

Industry is still fragmented, and the ability to gain traction

within the small and midsize markets positions the company to

begin engaging larger clinical organizations

•

Operational in the U.S., Germany and Russia with support

services available in six languages covering the largest 98% of

clinical trial providers

Industry

Growth

Customer

Service

Clinical

expertise

International

Platform

Experienced

Management

Sales

Momentum

Page 29

First in Functionality

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OmniComm Systems, Inc.

Thank You

For more information, please contact:

Stephen Johnson,

Ronald Linares,

Chief Operating Officer

Chief Financial Officer

sjohnson@omnicomm.com

rtlcfo@omnicomm.com

OmniComm Systems, Inc.

954-473-1254