Contract Research Organization
Latin America
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Agenda
Who we are
Services
Our strengths
Our philosophy
Why KLIXAR
Why Latin America
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Who we are
Clinical services Phase II to IV
Contract Research Organization
Latin America
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Who we are - Coverage
Brazil, Chile and Central America covered through local CRO partners
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Managing Director
Clinical Operations Regulatory Affairs Quality AssuranceClinical Supplies
Administrative support
Who we are
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Services
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Services
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
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
KLIXAR offers a broad spectrum of services in the clinical research field, including:
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Services
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Services
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
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
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
StrengthsManagement team Flexibility
Local expertise
Investigator database
Communication
Efficiency
Quality
Regulatory
Our strengths
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Our strengths - Quality
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
VP
Clinical OperationsExecutive Director
Clinical Operations Director
Associate Director
Associate Director
Project Manager
Clinical Team Leader
Monitor Monitor
Director, Regulatory Affairs
Associate Regulatory Manager
Regulatory Officer
Regulatory Officer
Clinical Start Up Manager
Regulatory Specialist
Regulatory Specialist
Clinical Start Up Coordinator
Clinical Start Up Associate
Clinical Assistant
Clinical Start Up Assistant
Regulatory Assistant
Clinical Operations
Clinical Start Up
Regulatory Affairs
Our strengths - Structure
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Project Manager
Clinical Team Leader
Monitor Monitor
Clinical Assistant
Managing Director
Clinical Operations & Regulatory Affairs
Manager
KLIXAR
Clinical Start Up Manager
Clinical Start Up Coordinator
Associate Regulatory Manager
Regulatory Officer
Regulatory Specialist
Clinical Start Up Associate
Other CROs
Project Manager
Clinical Team Leader
Monitor Monitor
Clinical Assistant
Our strengths - Structure
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
TrainingOrganizational
structure EnvironmentCommunication Feedback
Our philosophy
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Why KLIXAR
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Why Latin America for Clinical Research?
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Mean number of patients per site by region where patient enrolment was completed (2003-2005)
Why Latin America
Source: CMR International
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
81% of region population138% of EU population*113% of USA population
Why Latin America
Source: United Nations. Department of Economic and Social Affairs, Population Division (2007). World Population Prospects: The 2006 Revision
*Countries described
Country Population Country PopulationArgentina 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
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Central AmericaInhabitants: 21,3 mill
Inhabitants: 42,0 millBogotá: 8,5 millMedellín & Cali: 6,2 mill
Inhabitants: 28,7 millLima: 8,2 mill
Inhabitants: 40,3 millBuenos Aires: 14,9 millCórdoba y Rosario: 2,8 mill
Inhabitants: 190,0 millSao Paulo: 20,6 millRio de Janeiro: 12,3 mill
Why Latin America
Source: United Nations. Department of Economic and Social Affairs, Population Division (2007). World Population Prospects: The 2006 Revision
Inhabitants: 16,6 mill
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Start up timelines (In weeks)
Costa Rica: Regulatory timelines for Phase I / II studies only. For Phase III / IV studies is 13 weeks
6.5
9.0
6.9
5.5
7.4
6.9
6.5
7.9
Months
0 5 10 15 20 25 30 35 40
Perú
Panamá
Guatemala
Costa Rica
Colombia
Chile
Brazil
Argentina
4
4
4
4
4
4
4
4
21
24
29
25
16
22
31
22
3
2
1
3
4
4
4
2
Translations/Doc collection Regulatory Importation process
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Latin America
Why Latin America
Opportunities
Seasonal disorders
Indications (eg. Diabetes)
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Large treatment-naïve populations concentrated in metropolitan areas
Large treatment-naïve populations concentrated in metropolitan areas
Centralized healthcare delivery
Centralized healthcare delivery
Strong patient-physician relationships
Strong patient-physician relationships
Rapid patient enrollment in clinical trials
English speaking investigatorsEnglish speaking investigatorsImproved medical infrastructure
Improved medical infrastructure
Increased awareness of ICH/GCP requirements
Increased awareness of ICH/GCP requirements
Patients have strong incentives to participate
-Access to U. Hospitals, medications-More intensive treatment, no waiting
Patients have strong incentives to participate
-Access to U. Hospitals, medications-More intensive treatment, no waiting
Why Latin America
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Enrollment delay(% clinical trials)Enrollment delay(% clinical trials)
Latin AmericaLatin America
41%
EuropeEurope
55%
USAUSA
70%
Source: Thomson CenterWatch surveys
Why Latin America
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
In Summary
• Latin America can be taken into account not only as a rescue trials area
• KLIXAR offers services in the most important LA countries• Although regulatory frames are not on line with international
standards, the recruitment rates are usually higher than traditional countries
• Quality is not an issue
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Indication Phase Country # Sites initiated
Enrollment target
Enrollment actual
Percent to target
enrollment
FPI target FPI Actual LPI target LPI actual Enrollment period
(months)
Enrollme nt rate
(pts/month)ARGENTINA 5 50 24 48% 1-Apr-06 2-May-06 30-Jul-06 29-Jun-06 1.9 12.8CHILE 2 10 11 110% 1-Apr-06 29-May-06 30-Jul-06 31-May-06 0.1 166.7COSTA RICA 2 10 24 240% 1-Apr-06 2-May-06 30-Jul-06 13-Jun-06 1.4 17.7GUATEMALA 2 10 21 210% 1-Apr-06 24-Apr-06 30-Jul-06 26-Jun-06 2.0 10.3PANAMA 2 10 27 270% 1-Apr-06 15-May-06 30-Jul-06 29-Jun-06 1.5 18.6
Internal Medicine*Pancreatic Insufficiency
III ARGENTINA 1 10 21 210% 20-Oct-07 19-Dec-07 30-Apr-08 26-May-08 5.2 4.1
ARGENTINA 6 36 64 178% 15-Sep-05 5-Oct-05 30-Sep-07 9-May-07 18.9 3.4
BRAZIL 6 36 85 236% 1-Sep-05 24-Sep-05 30-Sep-07 16-May-07 19.5 4.4
ARGENTINA 15 95 87 92% 22-abr-06 22-may-05 5-nov-07 13-nov-07 29.4 3.0BRAZIL 31 235 190 81% 31-mar-06 25-abr-06 5-nov-07 13-nov-07 18.4 10.3CHILE 4 25 14 56% 31-mar-06 3-may-06 5-nov-07 13-nov-07 18.1 0.8
ARGENTINA 26 57 50 88% 12-Aug-06 4-Sep-06 31-Jul-08 25-Jul-08 22.5 2.2BRAZIL 29 112 115 103% 15-Jul-06 13-Nov-06 31-Jul-08 25-Jul-08 20.2 5.7
ARGENTINA 2 12 12 100% 27-Feb-07 15-Aug-0 7 30-Jul-08 30-Jun-08 10.4 1.2BRAZIL 3 17 13 76% 30-Mar-07 15-Jan-08 30-Jul-08 30-Jun-08 5.4 2.4
ARGENTINA 5 15 32 267% 28-Jan-08 23-Apr-08 28-Nov-08 22-May-08 1.0 33.4BRAZIL 7 21 27 159% 28-Jan-08 23-Apr-08 28-Nov-08 3-Jun-08 1.3 20.5
Oncology*Prostrate Cancer III
IIINephrology*Renal Transplant
Oncology*Renal Transplant II
Oncology*Metastatic Colorectal Cancer
III
IIIInfectious Disease*H IV
IIINephrology*Type 2 Diabetes
Case studies
KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com
Indication Phase Country # Sites initiated
Enrollment target
Enrollment actual
Percent to target
enrollment
FPI target FPI Actual LPI target LPI actual Enrollment period
(months)
Enrollme nt rate
(pts/month)
ARGENTINA 2 10 11 11 0% 1-Nov-02 21-Jan-0 3 4-Mar-05 11-Mar-05 25.4 0.4
BRAZIL 6 64 90 14 1% 1-Dec-01 1-Jun-02 31-Jan-05 11-Mar-05 33.0 2.7
ARGENTINA 5 1 000 869 87% 17-Jun-04 14-Sep-04 31-Dec-05 12-May-05 7.9 110.7BRAZIL 8 360 1947 54 1% 17-Jun-04 31-Aug-0 4 31-Dec-05 2-Mar-05 6.0 324.3CHILE 2 396 54 14% 17-Jun-04 25-Oct-04 31-Dec-05 26-Jan-05 3.0 18.0COLOMBIA 6 265 820 30 9% 17-Jun-04 5-Oct-04 31-Dec-05 17-Mar-05 5.3 153.4
ARGENTINA 9 20 34 17 0% 22-May-08 26-May-08 6-Jun-08 6-Jun-08 0.3 103.1COLOMBIA 6 15 10 67% 19-May-08 28-May-08 6-Jun-08 6-Jun-08 0.3 37.9
ARGENTINA 7 24 20 83% 1-Aug-07 16-Aug-0 7 30-Nov-07 1-Nov-07 2.5 8.1CHILE 4 14 15 10 7% 1-Jul-07 28-Jun-07 30-Nov-07 22 -Oct-07 3.8 4.0COLOMBIA 5 17 16 94% 1-Aug-07 2-Aug-07 30-Nov-07 29 -Oct-07 2.9 5.6PERU 5 15 12 80% 1-Oct-07 23-Oct-07 30-Nov-07 5-Nov-07 0.4 30.3
ARGENTINA 10 110 136 12 4% 1-Jan-07 29-May-07 1-Oct-07 21-Aug-07 2.7 50.3COLOMBIA 5 50 49 98% 1-Jan-07 14-Apr-0 7 1-Oct-07 21-Aug-07 4.2 11.7PERU 3 75 15 20% 1-Jan-07 2 -Aug-07 1-Oct-07 22-Aug-07 0.7 22.7
ARGENTINA 11 112 122 10 9% 25-Dec-05 26-Dec-05 31-Aug-06 12-Sep-06 8.4 14.4CHILE 3 10 11 11 0% 25-Dec-05 4-Jan-06 31-Aug-06 6-Sep-06 8.0 1.4MEXICO 2 6 5 83% 25-Dec-05 4-Jan-06 31-Aug-06 31-Aug-06 7.8 0.6
IIIOncology*Primary Breast Cancer
IIINeurology*Parkinson's Disease
Rheumatology*Rheumatoid Arthritis
Rheumatology*Rheumatoid Arthritis
III
III
IIIOsteoporosis*Osteoporosis
Psychiatry*Schizophrenia IV
Case studies
Contract Research Organization
Latin America
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