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.

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.

• 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.

Good urban public health infrastructure.Good urban public health infrastructure.

Strong doctor-patient relationships.Strong doctor-patient relationships.

High professional standards.High professional standards.

Genetic diversity.Genetic diversity.

3/4 urban population.3/4 urban population.

100 million people.100 million people.

REACH, RECRUIT & RETAIN

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.”

COUNTRY APPROVAL TIME

Colombia 2.5-3 months

Ecuador 2.5-3 months

Peru 2.5-3 months

Venezuela 6 months

TIMELINES AND STRATEGY

Data ManagementData Management

Project ManagementProject Management

Patient RecruitmentPatient Recruitment

Site ManagementSite Management

Regulatory SupportRegulatory Support

SERVICES

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.

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.

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.

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.

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)

LOCAL KNOWLEDGE - DEMOGRAPHICS

0

20

40

60

80

100

120

Rate per

100,000

Top 4 Causes of Death in Latin America

Heart Disease

Cancer

Infectious Diseases

Diabetes

Source: Pan American Health Organization, 2002

INVESTIGATOR RESOURCES BYTHERAPEAUTIC AREA

0

5

10

15

20

25

30

35 Rheumatology

Endocrinology

Cardiology

Infectology

Otorrinolaringology

Gastroenterology

Oncology

Neurology

Pulmonar

CLINICAL EXPERIENCE: PROJECTS

Vaccines13%

Infectology7%

Tropical Diseases7%

Diabetes13%

Gastroenterology7%

Osteoporosis19%

Hyperlipidemia7%

Urology13%

Cardiology7%

Oncology7%

COMPLETED PROJECTS BY THERAPEUTIC AREA

SELECTED TRIAL EXPERIENCE

• Pasteur Merieux- Vaccine Trial• AstaMedica- Zentaris Tropical Disease• Glaxo/Kendle- Vaccine Trial

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.

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.

QualityQuality

Broad expertiseBroad expertise

Reduced trial delaysReduced trial delays

Fast response & FlexibilityFast response & Flexibility

Accelerated patient recruitmentAccelerated patient recruitment

Low clinical development costsLow clinical development costs

CONCLUSION