2. SIPLAS RO is a full service contract research organization CRO, offering nanotechnology, biopharmaceutical and medical device companies comprehensive monitoring and management services for conducting Phase II-IV clinical trials in the Andean region of Latin America.

3. OUR HISTORY 1973 - SIPLAS Clinical Laboratory established (SIPLAS LAB). 2000 - SIPLAS Research Organization established as an independent offshoot of SIPLAS LAB. 2000 - SIPLAS RO contracts for first project; monitoring a phase III study at 4 sites in Colombia, 1 site in Guatemala. 2005 - Business Development offices opened in USA and Canada.

4. The Untapped Region. Geographical advantage: close to the US. Treatment-Naive patients. WHY THE ANDEAN REGION? Indications: specific to this region and with worldwide impact. Diagnosis and treatments: still not fully explored. Population: Concentrated in urban areas and willing to participate.

5. Good urban public health infrastructure. Strong doctor-patient relationships. High professional standards. Genetic diversity. 3/4 urban population. 100 million people. REACH, RECRUIT & RETAIN

6. WHY SIPLAS RO? Andean Region is full of advantages. We have a strong presence in this region: Clinical HQ and Clinical Sites in all these countries. Local people that make the difference: Know the culture Dominance of Market Individualized Customer Service “We are a reliable regional expert who knows the territory and can help you meet your goals.”

7. COUNTRYAPPROVAL TIME Colombia2.5-3 months Ecuador2.5-3 months Peru2.5-3 months Venezuela6 months TIMELINES AND STRATEGY

8. Data Management Project Management Patient Recruitment Site Management Regulatory Support SERVICES

9. REGULATORY SUPPORT Document conversion. Presentations at Advisory Committee meetings. Reporting and tracking of adverse events. Preparation and maintenance of regulatory forms and files. Regulatory consultation and liaison with local regulatory services. Preparation of annual reports. U.S. and Latin America regulatory agent liaison for foreign companies.

10. SITE SELECTION Close interaction with site. Active throughout enrollment process. Regular updates to sponsor. Site Assistance; AE’s, SAE’s and protocol compliance. Assistance at any scale- single site or multicenter.

11. PATIENT RECRUITMENT We can ensure prompt enrollment for your studies by selecting experienced sites. Immediate access to an updated database containing medical records on potential study participants. Key strategic alliances and partnerships with Universities, Hospital and local HMO’s. With several clinical study locations in Latin America, SIPLAS RO offers much more flexibility than any other CRO.

12. PROJECT MANAGEMENT Initiation-Scope of Work, Contract, from BD to Project Management. Planning-staffing, financial, Risk Analysis. Monitoring Visits-Meetings, facilitate Communication btw Sponsor and Team. Controlling-Timelines, Quality Control, Status reporting. Close Out-Invoicing, Complete Close-out processes.

13. DATA MANAGEMENT Paper based data collection (CRF faxing and scanning, OCR capable). Internet applications for data collection (EDC) and distribution. SAS Programming Platform with EDC capability & study staff interface. EDC-readiness assessment ICT infrastructure services (help desk, local procurement, server administration, internet connectivity, in-situ technical support)

14. LOCAL KNOWLEDGE - DEMOGRAPHICS Source: Pan American Health Organization, 2002

15. INVESTIGATOR RESOURCES BY THERAPEAUTIC AREA

16. CLINICAL EXPERIENCE: PROJECTS COMPLETED PROJECTS BY THERAPEUTIC AREA

17. SELECTED TRIAL EXPERIENCE Pasteur Merieux- Vaccine Trial AstaMedica- Zentaris Tropical Disease Glaxo/Kendle- Vaccine Trial

18. FLEXIBILITY Small CRO with large CRO capability! Fast turnaround time & direct interface with director of your study. New technology: we have created platforms for Andean infrastructure that bring investigators on board & provide a sponsor-SIPLAS RO interface with our Data Management software. Your protocol, your needs; can scale up or down quickly; excellent capabilities for flexible & multi-arm trials. Ability to adapt. Willingness to adopt.

19. REGULATORY SUPPORT Document conversion. Presentations at Advisory Committee meetings. Reporting and tracking of adverse events. Preparation and maintenance of regulatory forms and files. Regulatory consultation and liaison with local regulatory services. Preparation of annual reports. U.S. and Latin America regulatory agent liaison for foreign companies.

20. Quality Broad expertise Reduced trial delays Fast response & Flexibility Accelerated patient recruitment Low clinical development costs CONCLUSION