A Regional CRO based in Buenos Aires

1. CompanyProfile PenthaResearchA South Cone Alliance Member

2. Full Service CRO Born on the basis of a SMO based in Buenos Aires, Argentina in 2003, PENTHA RESEARCH became later a regional full-service Contract Research Organization (CRO)covering, throughout South Cone Alliance, an operational field in South America and Mexico assisting the biotechnology, pharmaceutical and medical device industries in every activities of preclinical, clinical development (Phase I-IV Clinical Trials) and registration process.

3. WhatmakesPenthaResearchdifferent Directly linked with CRO services our R&D department proudly works in on a pipeline of new medical technology offered to investors and sponsors as a plus of opportunities to be developed according to their interests, and needs to explore new scientific horizons.

6. Web Site: www.pentharesearch.com

7. Company Status: LLC

8. ContactInformation: Gerardo M.Uviedo, MD- CEO E-mail: gerardo.uviedo@pentharesearch.com

9. PenthaResearchCapabilities Regulatory affairs Study Feasibility Study Start-Up Local Project Coordination Clinical Trial Management Regional Pharmacovigilance QualityAsuranceServices Research & Development

10. Study Feasibility Pentha Research process includes: I-Analysis on protocol in order to determine - Best country, PI, site to conduct the trial -Enrolment Projections - Overall costs II- Check up/comparison with historical database of like trial information III- Develop, distribute and assess site feasibility survey IV- Provide patient/site/month recruitment estimates

11. Regulatory Affairs Advice on Regulatory procedures in countries of operation Ethicscommitteesubmissions Site Regulatory Files management Management of IRB documents and operations Local and Regional Regulatory Agency approvals Import /Export licenses Custom consultancy and management

12. Study Start-Up Study Design, Protocol/CRF development Clinical Development Plans (PM, Monitoring, Quality, Communication, etc) Certified Translation of applicable documents Investigator/site selection & patient recruitment strategies Investigator Meeting Planning and execution Local regulatory documents collection & Management Preparation of country specific product labels Custom consultancy and management

13. Local Project Coordination This service provides sponsors/clients with legal representation in Latin America for the conduction of a clinical trial enabling Pentha research to: Execute contracts with PIs, sites & vendors on behalf of the client Administrate PI and vendor grants Represent sponsor at a local/ central EC´s and IRB´s Represent sponsor for importation purposes

14. Clinical Trial Management Activities involving Ongoing trial Management: Regulatory package preparation in accordance with country specific requirements Patient screening and randomization Site monitoring Project tracking via e-system Management of Drug supply, laboratories and local couriers Local and central safety management Communication with sites, sponsor and vendor /TLC, FtoF, internal project meetings)

16. QualityAsuranceServices Conduct of quality GCP audits Conduct of contract vendor/SUPPLIER AUDITS Conduct internal (staff) and external (sites) GCP training Development of Quality Plans, Quality Manuals, SOPs and SQPs

17. EARLY PHASE DEVELOPMENT DIVISION Itconsists of a exclusive 4 bedsuitlocated in one of ourbranches (Argentina) speciallyequipedtodevelopeearlyphasetrials (First in Human/IIa), combinedwith a highcomplexityfacility (Denton CooleySanatorium-BsAs) meetingalltherequirementsneededforsuccessfulexecution of thesestudies.

18. Research & Development Design of new medicaltechnology Set Up of preclinicalstudies Data Processing and Statistics