Our CompanyExodon offers a novel combination of CRO services. Over the past severalyears we have provided intelligent and creative solutions for acceleratingthe clinical trial process by identifying and selecting investigator sites usinga proprietary internationally based site and patient recruitment databasemodel.We also have been meeting the needs of pharmaceutical and nutraceuticalclients with smaller Phase I and II projects, bioequivalent, comparativeeffectiveness and post-marketing clinical research projects offering atimelier, cost-effective and comprehensive CRO solutions. We conduct themajority of these studies in our own clinical research units located in theUSA, India, the Philippines and Argentina. This approach allows for farmore control over the project which reduces both errors and cost, allowingfor faster completion of the clinical research project.
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
Product R & D DepartmentFrom 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
Product R & D DepartmentWe offer a timelier, more cost-effective and comprehensive CRO solutionfor our clients. We conduct the majority of these studies in our own clinicalresearch units with our in-house team of experts in pharmaceutical andnutraceutical product development, pre-clinical and clinical research trials.This approach allows for far more control over the projectwhich reduces both errors and cost, allowing for fastercompletion of the clinical research project.State of the Art Clinical Research Units (CRUs) India The Philippines USA Argentina
Product R & D DepartmentPharmaceutical, 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.
Product R & D DepartmentPhase 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
Product R & D DepartmentBioequivalence 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.
Product R & D DepartmentInvestigator – Initiated TrialsInvestigator Initiated Trials (IITs) are challenging as sponsors have to strike adelicate 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
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.
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.
Exodon VALIDATE System® and VALtrack™ Patient Recruitment Programs
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.
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.
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.
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
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.
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.
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.
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
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
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
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
CRO Sales OutsourcingExodon’s central andregional medical and R International Network of Healthcare providersnutraceutical sales R Scientifically-trained sales and medicalrepresentatives can representatives!educate, detail and sell your R Experienced professionals across multipleproducts to our global and specialitiesinternational network ofhealthcare R Affordable and flexible purchasing optionspractitioners. R Licensing agreements availableWe offer full as well asshared marketing and salesprograms to help you launchor revive your product line.
Looking forward to working with you!ExodonUS Headquarters111 Howard BlvdMt. Arlington, NJ 07856Contact No: 973-398-2900www.exodon.com