UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
AMENDMENT NO. 1 TO
FORM 8-K/A
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 14, 2004
IT&E International Group
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(Exact name of registrant specified in charter)
Nevada 000-50095 27-0009939
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(State of Incorporation) (Commission File Number) (IRS Employer
Identification No.)
31 N. Second Street, Suite 250, San Jose, CA 95113
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(Address of principal executive offices) (zip code)
Issuer's telephone number: (408) 938-1000 Fax number: (408) 947-1816
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Clinical Trials Assistance Corporation
2078 Redwood Crest, Vista, California 92081-7340
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(Former name or former address, if changed since last report)
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ITEM 1. CHANGE IN CONTROL OF REGISTRANT.
On April 14, 2004, Clinical Trials Assistance Corporation, a Nevada
corporation (the "Registrant") or ("CTAL"), Clinical Trials Assistance
Acquisition Corporation, a Nevada corporation ("Merger Sub") and IT&E
International, a privately-held California corporation ("IT&E"), entered into
a Acquisition Agreement and Plan of Merger (collectively the "Agreement")
pursuant to which the Registrant, through its wholly-owned subsidiary, Merger
Sub, acquired IT&E in exchange for 11,000,000 shares of the Registrant's
common stock which were issued to the holders of IT&E stock and 2,820,000
preferred shares, which can be converted for common shares at a ten-for-one
ratio, after they are held for two years (the "Merger"). Immediately after
the Acquisition was consummated and further to the Agreement, Kamill Rohny,
the controlling stockholder of the Registrant, cancelled 28,000,000 shares of
the Registrant's Common Stock held by him (the "Cancellation"). The
transaction contemplated by the Agreement was intended to be a "tax-free"
reorganization pursuant to the provisions of Section 351 and 368(a)(1)(A) of
the Internal Revenue Code of 1986, as amended.
The stockholders of IT&E (three stockholders owning 481,500 shares), who
unanimously approved the acquisition, and as of the closing date of the
Merger and after giving effect to the Cancellation, now own approximately 80%
of the Registrant's common stock outstanding as of June 10, 2004. This figure
is based on the issuance of 11,000,000 common shares and the conversion of
the newly issued 2,820,000 Preferred Shares and the conversion of 2,000,000
outstanding warrants.
Under Nevada law, the Registrant did not need the approval of its stockholders
to consummate the Acquisition and Merger, as the constituent corporations in
the Merger were Merger Sub and IT&E, which are business entities incorporated
under the laws of Nevada and California, respectively, and are in the same
general business. The Registrant is not a constituent corporation in the
Merger.
For accounting purposes, this transaction was being accounted for as a
reverse merger, since the stockholders of IT&E own a majority of the issued
and outstanding shares of common stock of the Registrant, and the directors
and executive officers of IT&E became the directors and executive officers
of the Registrant. Upon consummation of the Reverse Acquisition and after
giving effect to the Cancellation, the members of the Board of Directors of
the Registrant consisted of Peter R. Sollenne, Kelly Alberts and Tony Allocca;
Mr. Rohny resigned as the President and Mr. Rohny and Dr. Boling resigned as
Directors of the Company. No agreements exist among present or former
controlling stockholders of the Registrant or present or former members of
IT&E with respect to the election of the members of our board of directors,
and to the Registrant's knowledge, no other agreements exist which might
result in a change of control of the Registrant.
The Registrant intends to file an Information Statement on Schedule 14F1 with
the U.S. Securities and Exchange Commission with respect to a change of
directors for the Registrant.
2
Beneficial Owners
The following table shows the stockholdings of all directors and executive
officers of the Registrant, principal stockholders who own beneficially more
than five percent of the Registrant's issued and outstanding common stock,
and all directors and officers of the Registrant as a group as of June 10,
2004, after giving effect to the Reverse Acquisition and the Cancellation,
based on 19,000,000 shares outstanding at June 10, 2004.
Amount
Title Name and Address of shares Percent
of of Beneficial held by of
Class Owner of Shares Position Owner Class (1)
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Common Kelly Alberts(2) Pres/COO/Dir. 5,967,500 31.41%
Common Tony Allocca(3) VP Ops/Dir. 4,647,500 24.46%
Common Peter R. Sollenne(4) CEO/Director 385,000 2.03%
Common Mike Ruchman (5) VP Sales - -
Common Kamill Rohny(6) Shareholder 2,000,000 10.53%
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All Executive Officers as
a Group (4 persons) 11,000,000 57.89%
(1) The percentages listed in the Percent of Class column are based upon
19,000,000 issued and outstanding shares of Common Stock.
(2) Kelly Alberts, 31 N. Second Street, Suite 250, San Jose, CA 95113,
he will also receive 1,529,850 Preferred shares which converts to
ten-for-one common stock after a holding period of two years. These
shares have ten-for-one voting rights.
(3) Tony Allocca, 31 N. Second Street, Suite 250, San Jose, CA 95113.
he will also receive 1,191,450 Preferred shares which converts to
ten-for-one common stock after a holding period of two years. These
shares have ten-for-one voting rights.
(4) Peter R. Sollenne, 31 N. Second Street, Suite 250, San Jose, CA 95113.
he will also receive 98,700 Preferred shares which converts to
ten-for-one common stock after a holding period of two years. These
shares have ten-for-one voting rights.
(5) Mike Ruchman, 31 N. Second Street, Suite 250, San Jose, CA 95113.
(6) Kamill Rohny, 2078 Redwood Crest, Vista, California 92081-7340.
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ITEM 2. ACQUISITION OR DISPOSITION OF ASSETS.
Set forth below is certain information concerning the principal terms of the
Merger and the business of the Registrant and IT&E.
Principal Terms of the Reverse Acquisition and Plan of Merger
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At the Effective Time of the Merger (as defined in the Acquisition and Plan of
Merger Agreement), Merger Sub acquired 100% of the outstanding shares of IT&E.
The separate existence of Merger Sub ceased, and IT&E continued as a subsidiary
of the Parent corporation ("CTAL"), under the current name of the Registrant.
The Certificate of Incorporation of the Parent in effect immediately prior to
the Effective Time, remains the Certificate of Incorporation of the Parent.
The directors and officers of IT&E at the Effective Time of the Merger became
the directors and officers of the Parent.
Each share of IT&E common stock (an aggregate of 481,500 shares) was converted
into one share of the Registrant's common stock in the Reverse Acquisition, an
exchange ratio of 1:18.7 (the "Exchange Ratio") for 11,000,000 common shares
and 2,820,000 preferred shares, which can be converted for common shares at a
ten-for-one ratio, after they are held for two years.
Description of the Registrant
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The Registrant, a Nevada corporation, was incorporated on April 22, 2002. At
the, Effective Time of the Merger, the principal business objective and focus
of the Registrant was the "lifesciences" industry, which includes helping
physician researchers recruit appropriate patients to participate in specific
clinical research trials sponsored by the pharmaceutical industry.
An objective of the Registrant was to identify and acquire a business which
writes protocols for clinical research studies. CTAL recruits patients for
clinical studies and IT&E develops the protocols for these clinical studies.
The two companies enhance each others operations. Prior to the Effective Time,
Mr. Kamill Rohny and Dr. Eugene Boling were the directors of the Registrant.
Mr. Rohny and Dr. Boling resigned as directors of the Registrant immediately
after the Effective Time of the Merger. Mr. Rohny also resigned as an officer
of the Registrant after the Effective Time of the Merger.
The shares of common stock of the Registrant are traded on the OTC Bulletin
Board under the symbol "CTAL."
Following the Merger, the stockholders of IT&E became stockholders of the
Registrant. All executive officers of IT&E became executive officers of the
Registrant, and the Board of Directors of IT&E became the Board of Directors
of the Registrant. Upon the consummation of the Merger, IT&E became a wholly-
owned subsidiary of the Registrant, and the Registrant will change its name
to: IT&E International Group.
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Description of IT&E
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IT&E International is a for-profit lifesciences organization focused on
providing its clients with solutions to complex needs in clinical research
and regulatory compliance. IT&E was founded in 1996 and is incorporated in
the State of California.
IT&E's Business and Operations
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IT & E International, Inc. is a leading provider of a broad range of services
to the Life Sciences Industries. The company operates in two main divisions:
The Regulatory Affairs Division; and The Clinical Services & Solutions
Division.
The Regulatory Affairs Division provides services to pharmaceutical, biotech,
healthcare and other Life Science Companies providing to them the expertise
to evaluate, structure, implement and maintain effective quality programs and
processes that ensure compliance with applicable FDA regulations. This
Division offers a diverse all encompassing solution for the validation and
compliance of quality systems, lab and manufacturing processes, clinical
data systems, laboratory automation, content management, electronic document
management, and a complete solution for facilities, utilities and equipment
validation and compliance.
The Clinical Services and Solutions Division offers a full suite of clinical
trial support services. The services offerings include patient and
investigator recruitment, biostatistical analysis, data management, data
entry and verification and regulatory affairs services. In data management,
the group provides case reportform design, protocol development, data entry
and verification, full tracking and audit trail documentation, adverse
event reporting and FDA submission. The biostat group provides data mining
studies, data base design, representation at FDA and other regulatory
meetings, and additional specialized biostatistical analysis.
Program Management and Outsourcing
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IT&E's clients rely on IT&E to protect the integrity of their data and provide
for a secure environment for successful delivery. IT&E's program managers
consist of senior medical professionals with specific expertise in designing,
developing, and managing Phase I through III and Post-Marketing Clinical
Trials. Program managers work directly with our trial sponsors to ensure that
all deliverables are met and budget constraints are followed closely. They can
also serve as liaisons between the numerous coordinating sites and individuals
involved in the final completion of the project.
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A separate division of IT&E includes the IT&E International Validation &
Compliance. This Division offers a complete range of services from Management
Consulting to protocol development and execution. IT&E International Validation
& Compliance Division is dedicated to designing, developing and implementing
practices that protect the integrity of the computerized systems and equipment
used in health product research and manufacturing processes. IT&E ensures
these systems are maintained in a validated state throughout their entire
lifecycle by following documented protocols and standardized procedures. IT&E
International regulatory compliance division has the ability to deliver
services in the following fields:
o Guidelines Interpretation
o Planning & Strategy
o Corporate policies and procedures
o Methodology
o Independent Vendor Audits & Assessments
o SOP Generation and Revision
o Gap Analysis
o Risk Analysis - Business and Regulatory
o Remediation
o Training end users and program managers
IT&E International provides services in the CSV, Part 11, Part 210/211, Part 58,
Part 320, Part 820/QSR, GAMP4 as well as European and Asian standards. The IT&E
International Validation & Compliance Division designs, develops and implements
practices that protect the integrity of the computerized systems, equipment and
facilities used in health product research and manufacturing processes.
Further, IT&E ensures these systems are maintained in a validated state
throughout their entire lifecycle by following documented protocols and
standardized procedures. By analyzing market trends, continually reengineering
its best practices, utilizing leading technology and keeping abreast of changes
from the regulatory bodies, IT&E is able to ensure a high degree of Quality
Standards are being met.
Further, the ITE Compliance & Validation Division specializes in quality
procedures, programs and management consulting in FDA regulated areas within
the Pharmaceutical and Biotech Industries to include: audits, remediation,
quality systems, and validation and qualification of Processes, Cleaning,
Environment, and Computerized Systems. The ITE technical team has developed
and implemented several plant wide systems in the Pharma & Biotech Industries
and is a recognized and verifiable quality leader. Along with the strategic
alliance, of a Proprietary Methodology, with Correlate & IBM, ITE has developed
and has access to an extensive database which includes formats and templates
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to get projects off and running quicker and maximize the efficiency in
development and the ensuing validation & compliance processes. This Division
provides services focused around GxP Compliance, validation and regulatory
affairs for the Life Sciences Industry, including the following:
o Computer Systems Validation (CSV)
o 21 CFR Part 210/211 - Good Manufacturing Practices
o 21 CFR Part 11 - Electronic Signatures and Electronic Records
o Several other FDA and EMEA regulated areas
o Computerized Systems Validation
o Cleaning Validation
o Facility, equipment and Utility Validation
o Sterilization and Sanitization Validation
o Process Validation
The IT & E Clinical Services & Solutions Division offers a complete solution
for the clinical trials and clinical research industry. Included in the IT & E
offerings include:
Clinical Data Entry and Data Management
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ITE is capable of providing SAS (R) end-to-end solutions throughout every
stage of a drug's lifecycle: from discovery, development, and through
commercialization. The ITE Clinical Management Division focuses on assessing,
advising, and designing comprehensive systems solutions in the Pharmaceutical,
Biotech, and Medical Devices Industry. This Division provides leading and
emerging Pharmaceutical and Biotech Companies with project-based consulting
services in the areas of Data Management (SAS(R) databases and Oracle(R)
Clinical systems), Clinical Programming, Biostatistics, and Clinical
Validation (GCP). The ITE team of project/program managers bring an
average of 10+ years of Biopharma experience to their clients, as well as
the tools, talent and strategies necessary to carry a project from
conception to completion. ITE's extensive database selects and employs
project-specific analysts to provide constant monitoring of project scope,
budget, and deliverables while utilizing the ITE custom Project Tracking
System to provide clients with real-time, comprehensive status reports.
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Data Management
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ITE provides a full range of data management solutions, including SAS(R)
databases and Oracle(R) Clinical, as well as web-based or conventional
means of data capture. Following are some of the specific areas of
expertise:
o SAS (R) databases - Major functions supported
o Datasets
o Case Report Form design and analysis
o Safety Information
o Data marts for Data mining
o Integrated Data Analysis Systems
o Data Validation Specifications
o Database Design, install, and upgrade
o Data Quality Assurance
o Global Database Integration
o Oracle(R) Clinical - Major functions supported
o Define and manage a Clinical Study (Protocol)
o Define data elements to be collected in a Clinical study
o Define and generate data entry screens
o Define edit checks to be applied to the data
o Validation and derivation procedures [data]
o Collect and manage the data
o Data Extract to SAS for analysis
Clinical Programming
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The ITE Clinical Programming Group provides accurate and reliable programming
to support regulatory submissions and clinical study reports. Because of the
extensive experience of the ITE consultants, we are able to optimize the flow
of valuable scientific and operational data thereby assisting our clients to
get their products to market faster.
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Biostatistics
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The ITE Biostatistics Group is a team of highly skilled biostatisticians whose
focus is to deliver quality design consulting and statistical analyses for
clients engaged in complex clinical studies. This team delivers superior
results for targeted summaries of key findings within the regulatory finding
process, as well as producing creative scientific presentations. Some of
the areas of expertise are as follows:
o Clinical Study Design
o Estimation of sample size
o Trial duration
o Structuring of treatment comparisons
o Definition of key endpoints
o Number and timing of analyses
o Precise interpretations of results
o Data displays and interpretations
o Clinical development programs
o ISS/ISE preparation
o Prepare integrated clinical/statistical reports
o Design tables and graphics
o Analysis planning and preparation
o Summary of statistical methodologies
o Support submissions to regulatory agencies (FDA)
Clinical Validation (GCP)
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ITE's Clinical Validation Practice goes hand-in-hand with the efforts of the
Compliance Group. Our regulatory and safety services must compliment our
clients' drug development process from beginning to end. The ITE and Client
Partnership is truly a "Partnership That Works". By partnering with our
clients to design a study that combines an unsurpassed understanding of the
regulatory environment and current FDA regulations, we ensure a smooth and
efficient development cycle. ITE has designed its own Clinical Validation
Methodology for the enterprise that is designed to satisfy regulated business
practices and procedures that involves multiple groups within the organization
(users, systems, database administrators, and other support staff).
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Typically, the ITE Validation Plan describes the system and scope, outlines
the schedule and resources (GANTT), defines the testing strategy (and SOPs),
and describes the deliverables that will document the validation process.
The steps are as follows:
o Validation Plan Preparation
o System Inventory Preparation
o Preparing the work plan using the 5C's: System Classification, Complexity,
Control, Compliance, Criticality
o Preparing Individual System Profiles & Gap Analysis
o Global Technological & Procedural Gap Matrix Preparation
o Preparing, Monitoring and Executing various Validation Protocols
including Design Qualifications (DQ), Installation Qualifications (IQ),
Operational Qualifications, (OQ), Performance Qualifications (PQ),
Equipment Qualifications (EQ)
o Risk Analysis Matrix (The validation effort is premised on an determination
of risk and after addressing the 5 C's can we ascertain what level of
design documentation is sufficient for a specified system)
Competition
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The drug and medical device development outsourcing industry consists of
hundreds of smaller, limited-service providers and a number of full-service
global development companies. The industry continues to experience
consolidation and, in recent years, a group of large, full-service competitors
has emerged. This trend of industry consolidation appears to have created
greater competition among the larger companies for clients and acquisition
candidates.
In addition to competing with a number of other global, full-service companies,
IT&E also competes against some medium-sized companies, in-house research and
development departments of pharmaceutical and biotechnology companies, as well
as universities and teaching hospitals. In addition, the industry has few
barriers to entry. Newer, smaller entities with specialty focuses, such as
those aligned to a specific disease or therapeutic area, compete aggressively
against larger companies for clients. Increased competition might lead to
price and other forms of competition that might adversely affect our operating
results.
IT&E competes on the basis of a number of factors, including reputation for on-
time quality performance, expertise and experience in specific therapeutic
areas, scope of service offerings, price, strengths in various geographic
markets, technological expertise and systems, data management capabilities for
time savings with data integrity, ability to acquire, process, analyze and
report data in a time-saving accurate manner, ability to manage large-scale
clinical trials both domestically and internationally, and expertise and
experience in healthcare economics. There are no assurances that the IT&E
will be able to compete favorability in these areas.
10
For specialty areas such as laboratory and manufacturing validation, medical
communications, and protocol development, IT&E competes in a market that has
a myriad of niche providers. For the most part, these niche providers offer
specialty services and products with a focus on a specific geographic region,
a particular service or function and/or a specific stage or phase of drug
development. By contrast, IT&E provides its services on a global basis across
functional areas. IT&E competes principally on the basis of reputation,
scientific and technical expertise, experience and qualifications of
professional staff, quality of services, and ability to deliver quality
products to the client's specifications. The outsourced preclinical research
industry consists of a number of large providers and numerous smaller niche
companies. As such, there is significant competition for these opportunities,
and IT&E success will depend on our ability to identify and competitively bid
for risk-sharing programs that are likely to be productive.
Government Regulation
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IT&E's clients are subject to extensive regulations by government agencies.
Consequently, the services IT&E provides for these clients must comply with
relevant laws and regulations.
Prior to commencing human clinical trials in the United States, a company
developing a new drug must file an IND with the FDA. The IND must include
information about animal toxicity and distribution studies, manufacturing and
control data, stability data and a detailed plan, or study protocol, for the
proposed clinical trial of the drug or biologic in humans. If the FDA does
not object within 30 days after the IND is filed, human clinical trials may
begin. The study protocol will also be reviewed and approved by the
institutional review board, or IRB, in each institution in which a study is
conducted, and the IRB may impose additional requirements on the way in
which the study is conducted in its institution.
Human trials usually start on a small scale to assess safety and then expand
to larger trials to test efficacy along with safety in the target population.
The trials are generally conducted in three phases, which sometimes overlap,
although the FDA may require a fourth phase as a condition of approval. After
the successful completion of the first three clinical phases, a company
requests approval for marketing its product by submitting a new drug
application, or NDA. The NDA is a comprehensive, multi-volume filing that
includes, among other things, the results of all pre-clinical and clinical
studies, information about how the product will be manufactured and tested,
additional stability data and proposed labeling. The FDA's review can last
from six months to many years, with the average review lasting 18 months.
Once the NDA is approved, the product may be marketed in the United States
subject to any conditions imposed by the FDA.
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IT&E must conform to regulatory requirements that are designed to ensure the
quality and integrity of the testing process. To help ensure compliance with
these regulations, IT&E has established quality assurance at our laboratory
facilities to monitor ongoing compliance by auditing test data and conducting
regular inspections of testing procedures and our laboratory facilities.
Facilities
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IT&E International's headquarters are located at: 31 N. Second Street, Suite
250 San Jose, California 95113. The Company also has offices at:
6165 Greenwich Drive, Suite 170
San Diego, California 92122
One East Broward Boulevard, Suite 609
Fort Lauderdale, Florida 33301
222 S. Riverside Plaza, Suite 860
Chicago, Illinois 60606
203 East Main Street
Middleburg, Pennsylvania 17842
1050 17th Street, NW
Suite 600
Washington, DC 20036
Employees
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IT&E employs approximately 80-85 staff employees and utilizes the services
of approximately 50-55 outside consultants who work as independent contractors
for IT&E.
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Risk Factors
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The actual results of the combined company may differ materially from those
anticipated in these forward-looking statements. The Registrant and IT&E will
operate as a combined company in a market environment that is difficult to
predict and that involves significant risks and uncertainties, many of which
will be beyond the combined company's control. Additional risks and
uncertainties not presently known, or that are not currently believed to
be important, if they materialize, also may adversely affect the combined
company.
Risks Related to IT&E's Business
--------------------------------
IT&E's success depends in part on its ability to expand the content of its
existing business and build a wider customer a cost-effective manner and on a
timely basis. The expansion of IT&E's existing business and its development of
new programs may not be accepted by its customers. Even if IT&E is able to
develop acceptable new business models, it may not be able to introduce these
new business models as quickly as its customers require or as quickly as its
competitors.
Failure to adequately respond to changes in market needs and technologies could
have a material adverse effect on IT&E's business and results of operations.
Capacity constraints or system disruptions to IT&E's business models could
damage the reputation of IT&E and limit its ability to attract and retain
customers in the pharmaceutical and biotechnology industry.
Risk related to Government Regulations
--------------------------------------
The industry standards for the conduct of clinical research and development
studies are embodied in the regulations for Good Clinical Practice ("GCP").
The FDA and other regulatory authorities require that results of clinical
trials that are submitted to such authorities be based on studies conducted
in accordance with GCP. These regulations require that IT&E, among other
things: comply with specific requirements governing the selection of
qualified investigators:
o obtain specific written commitments from the investigators;
o verify that appropriate patient informed consent is obtained;
o monitor the validity and accuracy of data;
o instruct investigators and studies staff to maintain records and reports;
o permit appropriate governmental authorities access to data for their
review.
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IT&E must also maintain reports for each study for specified periods for
auditing by the study sponsor and by the FDA. IT&E is liable to its clients
for any failure to conduct their studies properly according to the agreed upon
protocol and contract. If IT&E fails to conduct a study properly in
ccordance with the agreed upon procedures, IT&E may have to repeat the study
at its expense, reimburse the client for the cost of the study and pay
additional damages.
Changes in trends in the pharmaceutical and biotechnology industries could
adversely affect IT&E's operating results.
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Industry trends and economic factors that affect the pharmaceutical and
biotechnology industry can also adversely affect IT&E's business. For example,
the practice of many companies in these industries has been to hire companies
like IT&E to conduct development projects. If these industries reduce their
tendency to outsource those projects, IT&E's operations, financial condition
and growth rate could be materially and adversely affected. In the past several
years, mergers and other factors in the pharmaceutical industry appear to have
slowed decision-making by pharmaceutical companies and delayed drug development
projects. Continuation or increases in these trends could have an ongoing
adverse effect on IT&E's business. If future regulatory cost containment
efforts limit the profits that can be derived on new drugs, the pharmaceutical
and biotechnology customers might reduce their drug discovery and development
spending, which could reduce IT&E's business.
IT&E's revenue depends on a small number of industries and clients.
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IT&E provides services to the pharmaceutical and biotechnology industries and
IT&E's revenue is highly dependent on expenditures by clients in these
industries. Currently, approximately 25% of IT&E's business is derived from
one customer. IT&E's operations could materially suffer if their largest
customer hires a different supplier for services provided by IT&E. The loss of
business from a significant client could have a material adverse effect on
IT&E's results of operations.
The Registrant cannot predict IT&E's future capital needs, and may not be able
to secure additional financing.
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The Registrant will likely need to raise additional funds in the future to fund
IT&E's operations, to expand its markets and product offerings, or to respond
to competitive pressures or perceived opportunities. The Registrant cannot
assure that additional financing will be available on favorable terms, or at
all. If adequate funds are not available when required or on acceptable terms.
14
Future acquisitions or investments could disrupt IT&E's ongoing business,
distract management and employees, increase expenses and adversely affect
IT&E's business.
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IT&E's management anticipates that a portion of any future growth of its
business might be accomplished by acquiring existing businesses, products or
technologies. The success of any acquisitions will depend upon, among other
things, management's ability to integrate acquired personnel, operations,
products and technologies into its organization effectively, to retain and
motivate key personnel of acquired businesses and to retain their customers.
In addition, IT&E might not be able to identify suitable acquisition
opportunities or obtain any necessary financing on acceptable terms. Any
future acquisitions could involve other risks, including the assumption of
additional liabilities and expenses, issuances of potentially dilutive equity
securities or interest-bearing debt, transaction costs, reduction in our stock
price as a result of any of these or because of market reaction to a
transaction, and diversion of management's attention from other business
concerns
IT&E's future success depends in part upon its ability to recruit and retain
key personnel.
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IT&E's success to date has been, and its continuing success will be,
substantially dependent on the continued services of its executive officers and
other key personnel, who generally have extensive experience in the industry.
IT&E's success also depends, in large part, upon its ability to attract and
retain highly qualified personnel familiar with current FDA regulations. IT&E
may have difficulty locating and hiring qualified personnel to fill open
positions, and retaining such personnel once hired. The loss of the services
of any key employees, or IT&E's failure to attract and retain other qualified
and experienced personnel on acceptable terms, could have an adverse effect
on its business and results of operations.
Risks Related to IT&E's Industry
--------------------------------
Competitors may harm IT&E's business by operating more effectively or more
efficiently in its market.
Changes in the extensive regulations to which IT&E is subject could increase its
cost of doing business or affect its ability to grow.
IT&E is subject to extensive federal regulation. New or revised interpretations
of the regulations by any of the regulatory entities that determine IT&E's
accreditation, could increase IT&E's cost of doing business.
15
Risks Related To Capital Structure
----------------------------------
There is no assurance of an established public trading market.
Although the Registrant's common stock trades on the NASD OTC Bulletin Board, a
regular trading market for the securities may not be sustained in the future.
The NASD has enacted recent changes that limit quotations on the OTC Bulletin
Board to securities of issuers that are current in their reports filed with the
Securities and Exchange Commission. The effect on the OTC Bulletin Board of
these rule changes and other proposed changes cannot be determined at this time.
The OTC Bulletin Board is an inter-dealer, Over-The-Counter market that provides
significantly less liquidity than the NASD's automated quotation system (the
"NASDAQ Stock Market"). Quotes for stocks included on the OTC Bulletin Board
are not listed in the financial sections of newspapers as are those for the
NASDAQ Stock Market. Therefore, prices for securities traded solely on the OTC
Bulletin Board may be difficult to obtain and holders of common stock may be
unable to resell their securities at or near their original offering price or
at any price. Market prices for the Registrant's common stock will be
influenced by a number of factors, including:
o the issuance of new equity securities pursuant to this, or a
future, offering;
o changes in interest rates;
o competitive developments, including announcements by
competitors of new products or services or significant
contracts, acquisitions, strategic partnerships, joint
ventures or capital commitments;
o variations in quarterly operating results;
o change in financial estimates by securities analysts;
o the depth and liquidity of the market for Registrant's common
stock;
o investor perceptions of our company and the technologies
industries generally; and
o general economic and other national conditions.
16
The Registrant's common stock could be considered a "penny stock."
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The Registrant's common stock could be considered to be a "penny stock" if it
meets one or more of the definitions in Rules 15g-2 through 15g-6 promulgated
under Section 15(g) of the Securities Exchange Act of 1934, as amended. These
include but are not limited to the following: (i) the stock trades at a price
less than $5.00 per share; (ii) it is NOT traded on a "recognized" national
exchange; (iii) it is NOT quoted on the NASDAQ Stock Market, or even if so, has
a price less than $5.00 per share; or (iv) is issued by a company with net
tangible assets less than $2.0 million, if in business more than a continuous
three years, or with average revenues of less than $6.0 million for the past
three years. The principal result or effect of being designated a "penny stock"
is that securities broker-dealers cannot recommend the stock but must trade in
it on an unsolicited basis.
Broker-dealer requirements may affect trading and liquidity.
------------------------------------------------------------
Section 15(g) of the Securities Exchange Act of 1934, as amended, and Rule 15g-2
promulgated thereunder by the SEC require broker-dealers dealing in penny stocks
to provide potential investors with a document disclosing the risks of penny
stocks and to obtain a manually signed and dated written receipt of the document
before effecting any transaction in a penny stock for the investor's account.
Potential investors in the Registrant's common stock are urged to obtain and
read such disclosure carefully before purchasing any shares that are deemed to
be "penny stock." Moreover, Rule 15g-9 requires broker-dealers in penny stocks
to approve the account of any investor for transactions in such stocks before
selling any penny stock to that investor. This procedure requires the
broker-dealer to (i) obtain from the investor information concerning his or her
financial situation, investment experience and investment objectives; (ii)
reasonably determine, based on that information, that transactions in penny
stocks are suitable for the investor and that the investor has sufficient
knowledge and experience as to be reasonably capable of evaluating the risks of
penny stock transactions; (iii) provide the investor with a written statement
setting forth the basis on which the broker-dealer made the determination in
(ii) above; and (iv) receive a signed and dated copy of such statement from the
investor, confirming that it accurately reflects the investor's financial
situation, investment experience and investment objectives. Compliance with
these requirements may make it more difficult for holders of the Registrant's
common stock to resell their shares to third parties or to otherwise dispose of
them in the market or otherwise.
Special note regarding forward-looking statements
-------------------------------------------------
Some of the statements under "Risk Factors" and elsewhere in this Current Report
on Form 8-K constitute forward-looking statements. These statements involve
known and unknown risks, uncertainties and other factors that may cause our
actual results, levels of activity, performance or achievements to be materially
different from any future results, levels of activity, performance, or
achievements expressed or implied by such forward-looking statements.
17
In some cases, you can identify forward-looking statements by terminology such
as "may," "will," "should," "could," "expects," "plans," "intends," "believes,"
"anticipates," "estimates," "predicts," "potential" or "continue" or the
negative of such terms or other comparable terminology.
Although the Registrant believes that the expectations reflected in the
forward-looking statements are reasonable, it cannot guarantee future results,
levels of activity, performance, or achievements. Moreover, neither the
Registrant nor any other person assumes responsibility for the accuracy and
completeness of such statements. The Registrant is under no duty to update any
of the forward-looking statements after the date of this report.
Management Of The Registrant After The Effective Date Of The Acquisition
------------------------------------------------------------------------
Directors And Executive Officers
--------------------------------
In connection with the Reverse Acquisition, all of the Directors and Executive
Officers of IT&E became directors and executive officers of the Registrant and
Kamill Rohny resigned as the President, and Mr. Rohny and Dr. Boling resigned
as directors of the Registrant. The following table sets forth the name and
position of each of the Registrant's directors and executive officers
immediately after the Effective Date of the Reverse Acquisition (April 14,
2004).
Name Age Position
---------------------- --- -----------------------
Peter R. Sollenne 55 CEO/Director
Kelly Alberts 36 President/COO/Director
Tony Allocca 60 VP Ops/Director
Mike Ruchman 54 Vice President Sales
Biographies
-----------
Peter R. Sollenne, CEO/Director
-------------------------------
Mr. Sollenne has over 28 years of experience in the Business Services, Financial
Services and Human Capital Industries. His experience includes hands-on
leadership of both large and middle-market public companies as well as small and
mid-sized private companies. Mr. Sollenne's most recent experience has been in
the Professional Services Industry, where he led the venture-backed rollup of
three International/Offshore IT Services companies; structured, negotiated and
closed over 30 acquisitions of IT Services & Human Capital companies over the
past 6 years; led the turnaround and re-positioning of two prominent Global IT
Services companies; has raised both public and private equity and debt; led the
18
entrance of Mexico's largest IT Professional Services Company into the United
States; and led the Sales & Marketing activities of a $1.0 billion division of
Ford Financial Services, leading this company from a second tier player to the
third largest in the Fleet Services Industry. Peter has held the positions of
President/COO for SOS Staffing Services (NASDAQ: SOSS), a $400 million 145
branch diversified staffing company; President/CEO of Inteliant, Inc., a $110
million IT Services roll-up formed by the acquisition and integration of 16
companies; President of Commercial Staffing Operations for Personnel Group of
America (NYSE: PGA) a $900 million diversified IT Services and Human Capital
Company; Founder/CEO/Director of re: Solutions Group, a Venture backed roll-up
in the IT Services Industry; Senior Vice President Sales & Marketing of USL
Capital, a subsidiary of Ford Financial Services; President/Founder of PHH
Financial Services (NYSE: PHH) a $500 million subsidiary of PHH Group (NYSE:
PHH) and Senior Vice President of Finance for PHH Fleet America, the nation's
second largest fleet leasing and fleet services company. Mr. Sollenne
received a BS in Accounting/Business Administration at Boston College and is
a CPA.
Kelly Alberts, Co-Founder, President/COO/Director
-------------------------------------------------
Kelly Alberts is the co-founder of IT&E and is a seasoned IT Services Executive
with over 13 years diverse experience in all phases of operations within the
services industry with emphasis on sales & marketing, setting policies,
procedures, cost controls, planning, team building, idea generation and
employee motivation. It was Kelly's (along with his Partner, Tony Allocca)
vision & strategy that led IT&E into the Pharma and Biotech Services
Industries, and he personally led the entre into the validation and
compliance services areas. As co-founder of IT&E, he led the sales &
marketing activities of the company exceeding over $20 million in sales in
the first 3 years. Prior to IT&E, he spent 5 years with National Software
Associates, a $200 million IT Services company that was acquired by Accustaff.
Kelly was the responsible for business development and sales for the Western
Region, which he grew from $1.0 million to over $23 million in just 2 years.
Kelly is a visionary and a strong leader who leads by example, and is the
driving force of the company's proprietary front end system, proprietary
delivery methodology, strategic alliances with IBM & Correlate, and the
VALTRACK system. Prior to this he spent 2 years with Oxford International, a
specialty IT Consulting Company where he quickly became a top revenue and
margin producer in less than one year. Before this, he owned his own
business in Iowa. Kelly received his BS from the University of Iowa.
19
Tony Allocca, Co-Founder, Vice President Operations/Director
------------------------------------------------------------
Tony Allocca is the other co-founder of IT&E and is a seasoned IT Services and
Engineering Services Executive with over 25 years experience. in all phases of
operations within the services industry with emphasis on sales & marketing,
operations, new market development, quality control, and customer relationship
building. It was Tony's (along with his Partner, Kelly Alberts) vision &
strategy that led IT&E into the Pharma and Biotech Services Industries. As
co-founder of IT&E, Tony wears many hats and is responsible for consultant
recruiting, resource management, customer relationships, strategic alliances,
back office support, RFP/RFQ's, etc, and a true leader. Prior to IT&E, Tony
spent 5 years with National Software Associates, a $200 million IT &
Engineering Services company that was acquired by Accustaff (now MPS Group).
Tony, along with his Partner Kelly, was also a VP Operations for the Western
US and from their Santa Clara office grew the operations from $1.0 million to
over $23 million in just 4 years. Prior to founding IT&E, he spent 4 years
with Tech Aid Corporation running the Southern California Region for this IT
and Engineering Services Company specializing in the refinery and utility
industries. Before this he was southeastern Area Vice President for a
specialty IT, Engineering and Staffing Company focused on servicing customers
in the defense industry. He was responsible for a $50 million region
covering the entire Southeastern US, covering Baltimore south. Tony is a
graduate of University of Maryland and served in the U.S.A.F.
Mike Ruchman, Vice President Sales
----------------------------------
IT&E International (1999 to Present) Sales Director for Regulatory
Compliance and Clinical consulting practices, focused on the highly regulated
Pharmaceutical, Biotech and Medical Device Industries. Manages clients,
employees and outside associates/consultants. Areas of specialization include:
Compliance & Validation, Management Consulting, Clinical outsourcing for
Biostatistics, SAS Programming, CRA's, Medical Writing and Data Management.
From 1997 to 1999, Mike was the Vice President of Sales for XXCAL/NTS Corp.
He was also a Vice President and Parter at Sharf Woodward & Associates from
1995 to 1997. Mike served as the Vice President of Sales for PCT Corp from
1992 to 1995 and from 1991 to 1992 served as a Regional Manager for Mini
Systems. From 1989 to 1991, he was a Sales Manager for XXCAL. Mike also served
as the Program Manager for the Technical Services Division from 1983 to 1989.
Mike holds a BS in Mechanical Engineering from California State University
Los Angeles, an MS in Civil Engineering from California State University Los
Angeles, an MBA and an MS in Information Systems Technology from the
University of Texas
20
Effective April 14, 2004, Kamill Rohny and Dr. Eugene Boling who were the
Registrant's directors prior to the Effective Time of the Merger, resigned,
in seriatim, and appointed its current directors and executive officers. See
"Change in Control of Registrant" of Item 1, above, and "Management of the
Registrant After the Effective Date of the Acquisition" of Item 2, above.
ITEM 5. OTHER EVENTS
Based on the acquisition of IT&E International, the Registrant has moved its
headquarters from 2078 Redwood Crest, Vista, California 92081-7340 to 31 N.
Second Street, Suite 250, San Jose, CA 95113, Phone: 408-938-1000, effective
April 14, 2004.
21
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.
Clinical Trials Assistance Corporation
By: /s/ Peter Sollenne
------------------------------------
Name: Peter Sollenne
Title: President
Dated: June 14, 2004
Exhibit Index
2.1* Acquisition Agreement and Plan of Merger, dated as
of April 14, 2004, by and among Clinical Trials Assistance
Corporation, Clinical Trials Assistance Acquisition
Corporation and IT&E Corporation
2.2** Revised Acquisition Agreement and Plan of Merger, dated as
of April 14, 2004, by and among Clinical Trials Assistance
Corporation, Clinical Trials Assistance Acquisition
Corporation and IT&E Corporation
3.4** Amended Articles of Incorporation, date June 14, 2004.
99.2** Audited Financials for IT&E Corporation
99.3** Pro forma Financials Clinical Trials Assistance Corporation
and IT&E Corporation
---------------------
* Previously filed with original Form 8-K with the Commission on April 15, 2004.
** This filing.
22
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND Exhibits.
(a) Financial Statements of business acquired.
The required financial statements of IT&E Corporation for the periods specified
in Rule 3-05(b) of Regulation S-X are included herein. This Amended Current
Report on Form 8-K amends Item 7(a) of the Form 8-K filed on April 15, 2004, by
attaching hereto as Exhibit 99.2 and incorporating herein by reference the
audited consolidated financial statements of IT&E Corporation for the years
ended December 31, 2003 and 2002.
(b) Pro Forma Financial Information.
The required Pro Forma financial statements of IT&E Corporation for are included
herein. This Amended Current Report on Form 8-K amends Item 7(b) of the Form 8-
K filed on April 15, 2004, by attaching hereto as exhibit 99.3 and incorporating
herein by reference the unaudited pro forma consolidated financial information
of the Company and IT&E Corporation.
(c) Exhibits:
2.2* Revised Acquisition Agreement and Plan of Merger, dated as
of April 14, 2004, by and among Clinical Trials Assistance
Corporation, Clinical Trials Assistance Acquisition
Corporation and IT&E Corporation
3.4* Amended Articles of Incorporation, date June 14, 2004.
99.2* Audited Financials for IT&E Corporation
99.3* Unaudited Pro Forma Consolidated Financial Information of
the Company and IT&E Corporation
---------------------
*This filing.
23