1. EXODON
Overview

2. Our Company
Exodon offers a novel combination of CRO services. Over the past several
years we have provided intelligent and creative solutions for accelerating
the clinical trial process by identifying and selecting investigator sites using
a proprietary internationally based site and patient recruitment database
model.
We also have been meeting the needs of pharmaceutical and nutraceutical
clients with smaller Phase I and II projects, bioequivalent, comparative
effectiveness and post-marketing clinical research projects offering a
timelier, cost-effective and comprehensive CRO solutions. We conduct the
majority of these studies in our own clinical research units located in the
USA, India, the Philippines and Argentina. This approach allows for far
more control over the project which reduces both errors and cost, allowing
for faster completion of the clinical research project.

3. Therapeutic Expertise
• Oncology
• Cardiovascular Diseases
• CNS
• Infectious Disease
• Rheumatology
• Endocrinology
• Nutrition

4. History of Work

5. PRODUCTS AND SERVICES
 Patient Recruitment
 Site Selection and Management
 Comprehensive Product R & D CRO services for
Phase I, II, PK/Bio-equivalence and IITs
 Outsourced Central and Field Medical Sales
Representatives
 Exodon’s Patient Services Center™ offers:
Healthcare/Lifescience Central Support Services

6. PRODUCT RESEARCH AND DEVELOPMENT
DEPARTMENT

7. Product R & D Department
From Concept to Closeout
 Pre-clinical Studies
 Nutraceutical Division
 Phase I and II Division
 Bioequivalence/PK Division
 Investigator Initiated Trials Division
 Outsourced Sale Representatives for approved products

8. Product R & D Department
We offer a timelier, more cost-effective and comprehensive CRO solution
for our clients. We conduct the majority of these studies in our own clinical
research units with our in-house team of experts in pharmaceutical and
nutraceutical product development, pre-clinical and clinical research trials.
This approach allows for far more control over the project
which reduces both errors and cost, allowing for faster
completion of the clinical research project.
State of the Art Clinical Research Units (CRUs)
 India
 The Philippines
 USA
 Argentina

9. Product R & D Department
Pharmaceutical, Nutraceutical, Medical Food and Biotech Companies
Many companies who make these products would love to test the safety
and efficacy of their products. But without adequate R & D funding,
which can often exceed several hundred thousand dollars to test their
products, these manufacturers have been unable to clinically test their
products - until now.
Exodon, in its ongoing efforts to transform clinical research, has
developed a cost effective way to test these dietary supplement,
functional food, pharmaceutical and nutraceutical products and those
that pass safety and efficacy testing, we design, develop, implement and
mange the necessary clinical trial to test the efficacy of the product in
humans. You just supply the product to be tested.

10. Product R & D Department
Phase I-II Studies
Drug Design and Consultation
Multinational Regulatory Affairs Filing
Phase I-II Clinical Trials Management
Drug Safety and Pharmacovigilance
Medical Monitoring
Data Capture and Management
Statistical Analysis and Medical Writing

11. Product R & D Department
Bioequivalence Studies
We offer you the opportunity to have your products undergo
pharmacokinetic studies - the study of the mechanisms of absorption
and distribution of an administered drug, the rate at which a drug action
begins and the duration of the effect, the chemical changes of the
substance in the body, and the effects and routes of excretion of the
metabolites of the drug.

12. Product R & D Department
Investigator – Initiated Trials
Investigator Initiated Trials (IITs) are challenging as sponsors have to strike a
delicate balance between providing oversight while maintaining a “hands-
off” approach.
Exodon and ERA Clinical can offer the following:
• Study design, protocol creation, CRF development and e-data mgt.
• Regulatory document preparation and IRB Submission
• Identification, selection, qualification and training of investigators
• Contract negotiation and management
• Monitor subject enrolment, and source document verification
• Write the FSR and assist investigator with publications, posters & presentations

13. VALIDATE System® and VALtrack™ Site Selection

14. VALIDATE System® Site Database
 VALIDATE System® site database- this system identifies
clinical trial sites with the necessary experience in the
needed therapeutic area that likely has the necessary
patient population for the study. The patient data from
these sites can be searched by the study I/E criteria.
Additionally we have various site metrics on these sites such
as PI experience, on-site staffing, equipment at site or
available, etc. Confirmation of patient population will be
performed prior to site submission to the sponsor.

15. VALtrack™ site database
 VALtrack™ site database – is an international database of
physicians per therapeutic area that we screen. All VT sites
will be contacted, screened and validated by our medical
liaison and study start up specialist teams to as part of the
site feasibility process. Those sites that pass the screening
for this study are moved into our VS site database, their
patient data pre-screened and selected sites forwarded to
the sponsor.

16. Exodon VALIDATE System® and VALtrack™
Patient Recruitment Programs

17. Exodon’s VALIDATE System®
Patient Recruitment Database
 Database includes searchable de-identified medical records
of patients from multiple global regions that have pre-
consented for participation in upcoming clinical research
trials
 The patients in our VS database have authorized us and
their treating doctors to find new diagnostic and treatment
options relevant to their condition(s) by signing a HIPAA
Authorization and pre-consent form. The pre-consent form
is an Informed Consent without naming a specific trial.

18. Exodon VALtrack™
Direct Patient Recruitment Database
Contains Approximately 42 million Patients
 Is a much larger database of approximately 40 million patients,
some who have opted in to participate in clinical trials.
 The patients in the database are not yet pre-consented or if they
opted to participate in clinical trials we do not have access to their
full medical records.
 We have various levels of diagnostic and clinical related information
on our VT patients and the ability to pre-screen and pre-consent
those who meet criteria for our clients’ trials. Those patients who
meet criteria and want to participate in the trial are referred to the
already enrolled study site.

19. Some Patient Recruitment Vignettes
 Pediatric Bipolar Disorder Phase III Trial
 Recruited 6 VS sites during site-selection with an average of 6 pre-consented
Pts per site; 32 of these patients were successfully enrolled into this study shortly
after their SIV. 4 pre-qualified patients per month were referred to sponsor sites
throughout the length of this contract.
 PFO Migraine Phase III Trial
 Referred an average of 14 pre-consented and pre-qualified migraine patients
each month to be screened at sponsor sites for a period of approx. 1 year.
 Hepatitis B Phase II Trial
 Successfully recruited 5 sites in Eastern Europe with approximately 50-60
pre-
consented patients and 3 sites in the US with 16 pre-qualified pts. Their patient
enrollment was completed before the trial started.

20. Some Patient Recruitment Vignettes
 Cancer Pain Study
 2 network sites participated. Ranked the highest enrolling site in the
 multisite international trial.
 Chemotherapy induce nausea study
 3 network sites participated in the study. Ranked the highest enrolling site in the
 multisite international trial.
 Breast Cancer Study
 Joined the study in the late stages, but still had 14 out of 57 screened patients
 enrolled into the study.
 Ovarian Cancer Study
 1 network site participated – enrolled 4 patients
 Enrolled 3 patients from a database approach for Patient Recruitment for other study
 sites

21. Screening Centers
• Point of care centers that have the patient
population needed for the trial , but not
participating in clinical trials.
• Patients are pre-screened against the
Inclusion/Exclusion criteria, and qualified candidates
are referred to the nearest study site for final
screening.

22. Referral Centers and Site Based
Patient Recruitment
 Patient Support Groups  Site-based
and Community Outreach
Using the searching software
Programs built into our VALIDATE System
Exodon has established we have developed a quick and
relationships with patient effective method to help study
support and advocacy groups sites reach out within minutes
worldwide who refer patients to all their patients with the
matching their medical profiles study diagnosis. Either the site
to different clinical trials or Exodon’s doctors then
opportunities. screen these patients for
eligibility into the trial. This
approach is coupled with
proven trial promotional
strategies at the site level.

23. Public Relations and Media-based
Patient Recruitment
 PR, TV, Radio, and the Internet
The director of this division has 20
years experience in promoting clinical
trials and new healthcare options thru
strategic PR campaigns and broad
based media. This division nicely
supplements our database-driven
patient recruitment solutions.

24. Patient Recruitment Performance-based Pricing
 VS and VT products  Media-based
 Set-up and performance  Budget driven
 Screening Centers  Site-selection
 Set-up and monthly fee  Screening fees
 Selection fee optional
 Referral Centers
 Per Active Center
We use a shared-risk partnership model
with our clients based on performance

25. Site Selection Metrics
 We use our Top 30 Model per Medical Discipline
 Model is expandable based on needs of client
 World Wide Study Center Options
 Asia and Asia-Pacific Region
 India
 Latin America
 Eastern and Western Europe
 US and Canada
 Sites are selected based on experience, ability to meet the study
requirements and the number of pre-consented patients meeting the
protocol’s requirements at each site

26. Site Selection Features & Benefits
 Systematic, comprehensive and objective method of identifying
potential sites from Exodon’s Worldwide Network of Clinical
Investigators.
 Potential Clinical Investigators are experienced in their field of medical
specialization and can implement studies immediately.
 Complete investigator’s information on their medical practice, patients,
study history, site facility, etc.
 Established professional and working relations for smooth coordination.
 Targets your precise therapeutic areas of interests/topics

27. Patient Services Center™ and Medical Sales
Representatives
 Our 1,000 seat clinically staff Patient Services Center™
specializes in pre-screening patients for clinical trials,
conducting healthcare assessment, medical triage and
support services. All clinicians are supervised by doctoral-
level supervisors
 Outsourced central and field sales representative to detail
and sell client products globally to a wide network of
healthcare practitioners

28. CRO Sales Outsourcing
Exodon’s central and
regional medical and R International Network of Healthcare providers
nutraceutical sales R Scientifically-trained sales and medical
representatives can representatives!
educate, detail and sell your
R Experienced professionals across multiple
products to our global and specialities
international network of
healthcare R Affordable and flexible purchasing options
practitioners. R Licensing agreements available
We offer full as well as
shared marketing and sales
programs to help you launch
or revive your product line.

29. Looking forward to working with you!
Exodon
US Headquarters
111 Howard Blvd
Mt. Arlington, NJ 07856
Contact No: 973-398-2900
www.exodon.com