Klixar Presentation (Aug 2009)

Contract Research Organization

Latin America

Agenda

 Why Latin America
 Who we are
 Services
 Our strengths
 Our philosophy
 Why KLIXAR

KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com

Why Latin America for
Clinical Research?


Why Latin America
Mean number of patients per site by region where patient
enrollment was completed (2003-2005)

Source: Centre for Medicines Research International Limited (CMR)


Why Latin America

Country Population Country Population
Argentina 38,970,911 USA 299,398,484
Brasil 186,770,582 France 63,714,000
Chile 16,432,674 Great Britain 60,777,600
Colombia 46,772,286 Spain 40,444,800
Perú 28,348,700 Italy 58,148,000
Central America 21,300,000 Romania 22,276,000
338,595,153

81% of region population
138% of EU population*
113% of USA population

*Countries described

Source: United Nations. Department of Economic and Social Affairs, Population
Division (2007). World Population Prospects: The 2006 Revision


Why Latin America - Population

COLOMBIA: 42.0 MM
Bogotá: 8.5 MM
Medellín & Cali: 6.2 MM

Central America BRAZIL: 190.0 MM
(3 countries): 21.3 MM Sao Paulo: 20.6 MM
Rio de Janeiro: 12.3 MM

PERU: 28.7 MM
Lima: 8.2 MM

CHILE: 16.6 MM

Source: United Nations. Department of Economic ARGENTINA: 40.3 MM
and Social Affairs, Population Division (2007). World Buenos Aires: 14.9 MM
Population Prospects: The 2006 Revision Córdoba & Rosario: 2.8 MM


Start up timelines (in weeks)
Months

Argentina 4 30 2 8.5
Brazil 4 17 4 6.0
Chile 4 22 4 7.0
Colombia 4 16 4 5.5
Costa Rica (phase III-IV) 4 14 3 4.9
Costa Rica (phase I-II) 4 25 3 7.5
Guatemala 4 29 1 8.0
Panamá 4 24 2 7.0
Perú 4 21 3 6.5
0 10 20 30 40
Weeks

Translations/Doc collection Regulatory Importation process

Costa Rica: Regulatory timelines for Phase I / II studies only. For Phase III / IV studies is 13 weeks


Why Latin America

Seasonal disorders

Latin America Opportunities

Indications (eg. Diabetes)


Why Latin America
Patients have strong incentives to participate
Large treatment-naïve -Access to University Hospitals
populations concentrated in -Access to medications
metropolitan areas positive for -Better healthcare
-Enrollment into clinical trials -More intensive treatment
-Commercial sales (ROI) -No waiting

Increased awareness of
Strong patient-physician ICH/GCP requirements
relationships Centralized healthcare
delivery

Improved medical English speaking investigators
infrastructure – strong alliance
with US medical community

Rapid enrollment of evaluable patients
yielding high quality data


Why Latin America

Enrollment delay
(% clinical trials)

Latin America Europe USA

41% 55% 70%

Source: Thomson CenterWatch surveys


Who we are

Contract Research Organization

Clinical services Phase II to IV

Latin America


Who we are - Coverage

Brazil and Chile covered
through local CRO partners


Who we are

Managing Director

Financial Officer /
Executive Assistant

Clinical Operations &
Clinical Supplies Quality Assurance
Regulatory Affairs

Business
Medical Advisor
Development


Services


Services

KLIXAR offers a broad spectrum of services in the clinical research field, including:

 Start-Up Activities (including regulatory and clinical operation services)
 Site Identification
 Feasibility Reports
 Clinical Operations (including but not limited to monitoring)
 Regulatory Affairs
 Project Management
 Clinical Trial Material Logistics
 In-sourcing

The following services will be provided through three separate US-based companies whose sole
focus is the activity for which they are contracted to provide quality, cost-efficient KLIXAR
deliverables in a timely manner:
 Medical Management, Drug Safety and Pharmacovigilance
 Data Management via Electronic Data Capture (EDC)
 Biostatistics and Data Analysis


Services

Project
Start up activities Clinical Operations Regulatory Affairs
Management

• Including • Monitor time, cost • Monitor time, cost • Prepare regulatory
regulatory and &, quality &, quality submissions to
clinical operation • Coordinate team, • Coordinate team, local
services customer & customer & committees/IECs
• Site selection vendor vendor • Prepare regulatory
• Support to patient communications communications submissions to
recruitment and • Employ risk • Employ risk local Regulatory
retention management management Authorities
• Site management • Provide training • Provide training • Maintain study
files – reports and
re-approvals
• Import/export
study materials


Services

Clinical Trial Investigators
In-sourcing General consulting
Supplies (CTS) trainings

• Individual • Consistency and • Teach adherence • KLIXAR can
professionals or locally conduct to ICH/GCP recommend
project teams services standards different
• Short- or long- • Streamline • Educate all approaches for
term communications investigative site the development
• All experienced of all parties staff on local of a study
levels involved regulations
• Many countries • Provide • Define protocol
experienced specific
regulatory requirements
oversight
• Create and
maintain a
standardized
network of study
supply depots


Services – Clinical Study Supplies

 Clinical supply logistic – Project Management
 Start up study support and project/depot set up
 Receipt, accountability, and storage
 Warehousing management
 Distribution, shipment handling
 Labeling process
 Final disposal, destruction
 Comprehensive services and general project support
 Customer support on regional services
 Quality Assurance


Our strengths

Strengths
Management team Flexibility

Efficiency Local expertise

Quality Communication

Regulatory Investigator database


Our strengths - Quality

• Own set of SOPs
SOPs • Reviewed periodically

• New business partners

Audit select the audit
company
• KLIXAR covers labor


Our strengths – Big CRO structure
VP
Clinical Operations Regulatory Affairs
Clinical Start Up
Clinical Operations
Executive Director

Clinical Operations Director,
Director Regulatory Affairs

Associate Associate Clinical Start Up Associate
Director Director Manager Regulatory Manager

Project Clinical Start Up Regulatory Regulatory
Manager Coordinator Officer Officer

Clinical Team
Leader

Clinical Start Up Regulatory Regulatory
Monitor Monitor Associate Specialist Specialist

Clinical Start Up Regulatory
Clinical Assistant Assistant
Assistant


Our strengths – KLIXAR structure

KLIXAR Other CROs

Managing Director

Clinical Operations &
Regulatory Affairs
Manager

Project Project Clinical Start Up Associate
Manager Manager Manager Regulatory Manager

Clinical Team Clinical Team Clinical Start Up Regulatory
Leader Leader Coordinator Officer

Clinical Start Up Regulatory
Monitor Monitor Monitor Monitor Associate Specialist

Clinical Clinical
Assistant Assistant


Our philosophy

Organizational
Communication Feedback structure Training Environment

Listen to what our
clients really want Maintain a
Keep hierarchy
and need by Invest in continued professional and
Is the key for the structure small to
soliciting client relaxed environment
maintain a high clinical education
success of an feedback and fine conducive to
quality product at and training for our
organization. tune constantly — employee retention.
lower costs for our employees.
learn and be agile, Listen to our
customers.
available, proactive, employees.
and responsive.


Agenda revisited

 Who we are
 Services
 Our strengths
 Our philosophy
 Why KLIXAR


In Summary

 Who we are
 Services
 Our strengths
 Our philosophy
 Why KLIXAR


In Summary

 Why Latin America  High quality data with strong
inference to North American patient
 Who we are populations
 Services  Consider FIRST, not as a response to
enrollment lag (e.g. rescue sites)
 Our strengths  Recruitment rates mitigate less
favorable regulatory timeframes
 Our philosophy
 Why KLIXAR


In Summary

 Who we are  A Latin American CRO that offers services
in the most critical countries in Central
 Services and South America
 Our strengths
 Our philosophy
 Why KLIXAR


In Summary

 Who we are
 Services  Start-Up (including site identification)
 Regulatory Submissions
 Our strengths
 Clinical Monitoring
 Our philosophy  Project Management
 Clinical Trial Material Logistics
 Why KLIXAR
 Strategic Consulting


In Summary

 Who we are
 Services
 Our strengths  Experienced People
 Focused Communication
 Our philosophy
 Streamline Structure
 Why KLIXAR


In Summary

 Who we are
 Services KLIXAR

 Our strengths  Experienced People
 Focused Communication
 Our philosophy
 Streamline Structure
 Why KLIXAR
Blending these strengths and surrounding them with
a professional yet rewarding environment to
maximize employee retention

In Summary

 Why Latin America Quality

 Who we are
Care for the
Professionalism
 Services details

 Our strengths
 Our philosophy
Care for the
 Why KLIXAR people
Flexibility

Competitive
costs


Klixar Presentation (Aug 2009)

Recommended

Recommended

More Related Content

Recently uploaded

Recently uploaded (20)

Featured

Featured (20)

Klixar Presentation (Aug 2009)