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Activa Cro Presentacion Jan 09
1.
2. Company
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
• First spanish Latam CRO Certified ISO
9001: 2000 (2006)
• Operating in Uruguay since 2007
• Established in Mexico in 2008
3. A local CRO with regional reach
México
Chile
Uruguay
Argentina
4. 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.
5. 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
6. Our aim is to be the leading Regional spanish speaking
CRO in Latin America
Our strenght lies in local and regional expertise, continous training of our
staff and a robust Quality Assurance program
7. Organizational Chart
Board of
Directors
Regulatory Quality Mgnt. Business Administration
Legal External Clinical Trial
Affairs System Development & HHRR
Advisor Auditors Department
Department Department Department Department
Pharmaco- Quality Mgnt.
Project Quality Outsourcing Logistic & Administration
System HHRR
Managers vigilance Assurance Services Supply Chain & Finance
Auditor
Clinical
Research
Associates
8. Organizational Chart
Activa-CRO Headquarters Argentina - January 2009
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
Administration 5
Activa-CRO Chile 3
Activa-CRO Uruguay 2
Activa-CRO Mexico 4
9. Our services
Clinical research
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
• Investigator meeting organization and conduction
• Monitoring Services.
• Site Management.
• Project Management
10. Our services
Clinical research (cont)
• Study Design
• Protocol/CRF Development
• Local Project Coordination (includes sponsor representation for MOH
& customs, contacts with PI, sites and vendors
• Monitor Training
• Supplies warehousing
11. Our services
Regulatory affairs
• 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
• 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.
12. Our services
Pharmacovigilance Local Representation
• Receiving/Processing/Archiving adverse events in countries of
operation
• Ethics committee /IRB & MOH submissions
• Ensure compliance with local & International requirements
13. Our services
Quality assurance
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).
Activa is the first regional CRO certificated in Management and
Monitoring of Clinical Trials by ISO 9001:2000.
14. Our services
Training
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:
• GCP-ICH for investigators
• Monitoring by therapeutic area
• Individual Training Programs
16. Advanced Development Overall Experience December 2003- Jan. 2009
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
Geographical Location of Clients USA/Germany/Switzerland/Spain/Israel
/South Korea/Argentina
Regulatory authorities to whom data is to ANMAT/FDA/EMEA/South Korea
be submitted ANVISA/MOH Uruguay/Mexico/Chile
No. of Therapeutic Areas 11
Agents on which studies being conducted Drugs/Biologics/Devices
Type of Clients Small & Medium Biotech
Small & Big Pharma
Devices Industry
17. Our key factors for success
• 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
clinical development
• Our experienced staff is focused on patient safety , strictly
following ICH-GCP standards.
18. Why Latinamerica?
Population: Health System:
• Concentration of medical care in big cities
• Large patient population in almost all type of
• Public, Private, Community and Union
therapeutic indications Hospitals
• Treatment of native patients with similar • Modern central laboratory/imaging centers
ethnic characteristics • High level in telecommunications
infrastructure
• Excellent patient motivation
Sites:
• Experienced Investigators • Established, qualified investigators
Regulatory: • Motivated and enthusiastic investigators
• Well established regulatory environments • Accelerated patient recruitment rates
• Investigators with excellent retention of
• Acceptable regulatory approval timelines patients
• 100% GCP-ICH compliance • High quality data
Market: • Reduced operational costs
Geographical-Cultural:
• Fewer competitive studies
• Inversion of seasons
• Potential commercial market for new • Similar time zones as the United States
products • Prevalent European immigration
• Understanding of English is prevalent
