Activa is a full-service Contract Research Organization

(CRO) based in Buenos Aires, Argentina

• Established in 2003 in Argentina

• Economic growth rates doubling yearly

• Operating in Chile since 2004

Company

• Operating in Chile since 2004

• First spanish Latam CRO Certified ISO 9001: 2000 (2006)

• Operating in Uruguay since 2007

• Established in Mexico in 2008

A local CRO with regional reach

México

Argentina

Uruguay

Chile

Vision

Through the principles of scientific excellence, flexibility

and adaptability , our aim is to evolve into a “boutique”

CRO, offering specialized services to our clients

Mission

Our endeavour is to satisfy our client requirements and

expectations , working very close to them, in order to

facilitate an efficient management of their projects.

Activa was founded and is managed by senior professionals in Pharmaceutical, Medical device development and Regulatory affairs

We offer combined decades of experience developing basic & clinical research programs

Our aim is to be the leading Regional spanish speakingCRO in Latin America

Our strenght lies in local and regional expertise, continous training of our staff and a robust Quality Assurance program

Board ofDirectors

Legal Advisor

ExternalAuditors

Clinical Trial Department

RegulatoryAffairs

Department

Quality Mgnt.System

Department

BusinessDevelopmentDepartment

Administration& HHRR

Department

OrganizationalOrganizational ChartChart

Project Managers

ClinicalResearch

Associates

Pharmaco-

vigilance

QualityAssurance

Quality Mgnt.SystemAuditor

OutsourcingServices

Logistic & Supply Chain

Administration& Finance

HHRR

Organizational ChartOrganizational Chart

CTM/CRAs Full Time, Biol, MD,s 13

CRA/CRA ass outsourced to Big Pharma 8

Consultants, MDs 17

Regulatory & QA 4

Business Development 3

Activa-CRO Headquarters Argentina - January 2009

Administration 5

Activa-CRO Chile 3

Activa-CRO Uruguay 2

Activa-CRO Mexico 4

Our Scientific Advisory Committee (17 members at this time)

with key investigators and opinion leaders , enables us to

design studies for a wide range of therapeutic areas.

Clinical Research services include:

• Extensive PI Database

• Patient identification, recruitment and retention

Our services

Clinical research

• Patient identification, recruitment and retention

• Investigator meeting organization and conduction

• Monitoring Services.

• Site Management.

• Project Management

• Study Design

• Protocol/CRF Development

• Local Project Coordination (includes sponsor representation for MOH & customs, contacts with PI, sites and vendors

• Monitor Training

Our services

Clinical research (cont)

• Monitor Training

• Supplies warehousing

• Advice on Regulatory procedures in countries of operation

• Site Regulatory Files management

• Ethics committee submissions

• Management of IRB documents and operations

• Local and Regional Regulatory Agency approvals

Our services

Regulatory affairs

• Local and Regional Regulatory Agency approvals

• Import /Export licenses

• Custom consultancy and management

Our services include the preparation and submission of registration dossiers. We can recommend modifications in protocols in order to optimize the registration dossier, including evaluation of existing data.

• Receiving/Processing/Archiving adverse events in countries of operation

• Ethics committee /IRB & MOH submissions

• Ensure compliance with local & International requirements

Our services

Pharmacovigilance Local Representation

• Ensure compliance with local & International requirements

In December 2006, ACTIVA was granted the ISO 9001:2000

Standard Quality Certification on “Control and surveillance on

clinical research trial processes for the development of drugs,

biological products and medical devices” This certification was

issued by Bureau Veritas Certification and accredited by UKAS

(Europe), ANAB (North America) and OAA (South America).

Our services

Quality assurance

(Europe), ANAB (North America) and OAA (South America).

Activa is the first regional CRO certificated in Management and

Monitoring of Clinical Trials by ISO 9001:2000.

We offer in house training courses designed for clinical research

personnel. Through our associated "Clinical Research Training

Program" with academia (UBA, Fundación Margullies,etc) we

train investigators, monitors, study coordinators and regulators

with focus in the following areas:

Our services

Training

with focus in the following areas:

• GCP-ICH for investigators

• Monitoring by therapeutic area

• Individual Training Programs

ACTIVA-CRO Therapeutic Areas

• Dermatological

• Infectious Disease

• Metabolic

• Endocrinology

• Genitourinary

• Psychiatry• Metabolic

• Orphan Diseases

• Oncology

• Hematology

• Psychiatry

• Cardiovascular

• Neurology

Total No of Studies/Projects 36

No. of Studies/Projects Completed 16

No. of Studies/Projects Ongoing 20

No. of Studies/Projects in Start Up Phase 8

No. of Studies Projects currently active 12

No. of Active Sites 100+

No. of Patients 1000 +

Phases of Studies/Projects Pre-Clinical to Phase IV

Advanced Development Overall Experience December 2003- Jan. 2009

Phases of Studies/Projects Pre-Clinical to Phase IV

Geographical Location of Clients USA/Germany/Switzerland/Spain/Israel/South Korea/Argentina

Regulatory authorities to whom data is to be submitted

ANMAT/FDA/EMEA/South KoreaANVISA/MOH Uruguay/Mexico/Chile

No. of Therapeutic Areas 11

Agents on which studies being conducted Drugs/Biologics/Devices

Type of Clients Small & Medium BiotechSmall & Big Pharma

Devices Industry

• We recognize the need for shortened R&D cycles and reduced

costs for testing new products.

• We contact only distinguished and experienced clinical

investigators with combined experience and extensive databases

for patient enrollment.

• Directors have had hands on experience in all aspects of

Our key factors for success

• Directors have had hands on experience in all aspects of

clinical development

• Our experienced staff is focused on patient safety , strictly

following ICH-GCP standards.

Why Latinamerica?

Population:

• Large patient population in almost all type of

therapeutic indications

• Treatment of native patients with similar

ethnic characteristics

• Excellent patient motivation

• Experienced Investigators

Regulatory:

• Well established regulatory environments

Health System:

• Concentration of medical care in big cities

• Public, Private, Community and Union Hospitals

• Modern central laboratory/imaging centers

• High level in telecommunications infrastructure

Sites:

• Established, qualified investigators

• Motivated and enthusiastic investigators

• Accelerated patient recruitment rates• Well established regulatory environments

• Acceptable regulatory approval timelines

• 100% GCP-ICH compliance

Market:

• Fewer competitive studies

• Potential commercial market for new

products

• Accelerated patient recruitment rates

• Investigators with excellent retention of patients

• High quality data

• Reduced operational costs

Geographical-Cultural:

• Inversion of seasons

• Similar time zones as the United States

• Prevalent European immigration

• Understanding of English is prevalent