The document provides information about Blanchard & Asociados SRL, a clinical research organization based in Argentina. It details the company's mission to provide tailored, quality services to meet client needs, including GCP audits, quality system creation and consulting, and project management services. The document lists the experience and backgrounds of key personnel, including the executive director Anne Blanchard. It also includes information on research sites and sponsors/CROs the company has worked with.

1. Blanchard & Asociados SRL
Anne Blanchard, CCRA
Executive Director
anne@blanchardyasociados.com.ar
anne74@ciudad.com.ar
Assistance at meeting quality requirements through knowledge and organization.

2. Our Mission
• To provide tailor-suited services to meet
our clients needs for success and
efficiency
– based on our experience in clinical research.
– without compromising quality
– with a strong emphasis on training and
capability assessment

3. Our Vision
• Clinical studies seek to answer questions.
• Systematic Research is performed in a
controlled environment.
• Questions answered help advance
medicine.
• Advances in medicine help people count
with new treatment alternatives.

4. QUALITY services we provide:
• GCP Audits, System Compliance Audits
• Quality system creation and
implementation.
• Quality Consulting (assessments, advice)
• Training relevant to day-to-day practice in
clinical trials.

5. Project Management services
we provide:
• Regulatory Services
• Feasibility Assessment
• Clinical Trial Monitoring
• Co-Monitoring
• Mentorship Program

6. Who we work with
SPONSORS
MONITORING
QUALITY
SISTEM
QC CO- MONITORING
Site
Evaluation/
FEASABILITY
Diagnostic GCP ASSESSMENT
AUDITS
QUALITY
ORIENTED
INVESTIGATORS TRAINING
ADVICE

7. ORGANIZATIONAL
Executive Director CHART
Project Manager, Senior CRA
CRA II
Feasability &
CRA
Administration/ Logistics & SOP
Reception Administration
Desk
CRA
Trainee/ Assistant

8. Anne Blanchard
• Studied Biology and Languages
• Set up ICON Clinical Research offices in Argentina
1997.
• Worked as CRA in Ingenix, Eli Lilly, Abbott.
• Post Graduate as CRA at National Academy of
Medicine
• Started up B&A in 2003.
• Started a Non Profit Organization (Fundacion Dra.
Cecilia Grierson) dedicated to Clinical Research
Education in 2005.
• Certified as CRA in 2005 and Re Certified in 2007.
Responsible for ACRP Certification Exam in
Argentina

9. Paola Tapia, BSc
• Studied Biology at University of Buenos Aires
• Post Graduate as CRA at Bar Ilan University
• Worked for Aventis for 7 years
• Moved to Omnicare where she worked as
Lead CRA for 2 years
• Joined Blanchard & Associates in 2006
• Certified as CRA in 2007.
• Trainer at Fundacion Cecilia Grierson

10. Lorena Levi, Bsc
• Studied Biology at University of Buenos
Aires.
• Basic Science Researcher (2004-2008)
• Attended several training sessions in CR
since 2006.
• Study Coordinator at Neurological diseases
study 2007.
• Worked as Project Manager in Early Phase
studies for a CRO (Nov 2007-Jun 2008.

11. OUR EXPERIENCE
INITIALS AB (10 years) PT (11 years) LL (1.5 y)
CNS (3), EM(3), AIDS RESPITRATORY (3), CNS (1), AIDS
T. Area
(7), RA (1) RA (2), (3)
Experience CARDIOLOGY(1), HEMATOLOGY(1), EM
UROLOGY (2), (3)
HAEMATHOLOGY (1)
Dermatology, ONC, ONC, AIDS, ONC, Hepatitis
Additional
ANTI-INFECTIVES CARDIOLOGY C
expertise
PHASES I-II-III-IV II-III-IV I-IV

12. STAFFING DATABASES
Updated annually
Professionals from the entire Latin American Region
Professionals we are in contact with
MONITOR DATABASE (100+)
INVESTIGATOR DATABASE (1600+)
STUDY COORDINATOR DATABASE (40+)
OTHER SERVICES (20+)

13. South American
Investigator Database* (1600+)
•
• HIV/AIDS
Infectious Diseases
• Ophthalmology
• Oncology
• Respiratory
• Hematology
• Dermatology
• Diabetes
• Immunology
• Cardiology
• Critical Care
• Rheumatoid Arthritis
• Hepatic Diseases
• Alzheimer Disease/ • PSIQUIATRY
Dementia
• Gastroenterology
• Gynecology
*Updated Oct 2008

14. OUR SERVICES

15. What we are doing…
projected
2003 2004 2005 2006 2007 2008
cont (just sites
cont (just sites
Started up and sponsors)
and sponsors)
(website, cont
cont
QS/ QC-QM/
Newsletter *) QS/ QC-QM  cont (just
Cont (QS) And QA to sites
to sites sites and
QS/ QC-QM
GCP/LR and sponsors
and sponsors sponsors)
to sites
Training
and sponsors
Independent
to sites/ comm* Evaluation/ Evaluation/  QS/ QC-QM
GCP audits
Diagnostic Diagnostic Visit to sites
Evaluation/
QS to sites to Investigators
Visit to potential sites and sponsors
Diagnostic Visit
to potential
to potential sites
Monitoring
Independent
sites  Independent
for sponsors
GCP audits GCP audits
Independent
Independent to Investigators to Investigators
GCP audits
Advisor Feasibility
GCP audits
to Investigators
on NIH SOP GCP Advisor to Assessments
to Investigators  Monitoring
req. IEC at FMED-UBA for sponsors
GCP Advisor
Co-Monitoring
for grant app. Monitor Rental
To IEC at
Monitoring  Feasibility
FMED-UBA
Medical Writing
for sponsors Assessments
*Services Rendered to FCG
www.ceciliagrierson.org Data Management

16. RESEARCH SITES
CADE-ICA Endocrino metabolics
CIPREC S.A. Cardiovascular
INBA Neurology
Instituto de Alergia e Inmunology
Inmunología Clínica
Consultorio Medico Endocrino metabolics
Libertador

17. RESEARCH SITES
ACLIRES Pharmacology/Phase I
Unit
CETEN Oncology site
Fundación Rusculleda Endocrino Metabolics
/Cardiology
Hospital Misericordia Infectious Diseases
Centro Nacional de HIV/SIDA
Referencia para SIDA

18. SPONSOR/CRO
• Abbott
• ACLIRES Argentina/ ACLIRES International
• Aventis
• Eli Lilly
• ICON Clinical Research
• Ingenix Pharmaceutical Services
• IQ Global
• Johnson & Johnson
• Latintrials
• Omnicare Clinical Research
• Sanofi Aventis
• Servier

19. OUR PERSPECTIVE
1. To expand services throughout the Latin
American region in partnership with other
companies throughout the world.
2. To be able to balance our work at NGO with
our work at for profit.

20. OUR PERSPECTIVE
3. To build up a market brand with emphasis on
quality and Training in Clinical Research in the
execution of clinical trials.
4. To seek objectives without compromising
quality

21. Why choose us?
Personal commitment in each project assigned
to us.
We are a core team of very experienced Clinical
Research trainers and excellent communicators.

22. Why choose us?
Management at B&A knows what it takes to do a
good job… because we have done it. We will
commit to what we can provide.
Our reputation speaks for us.

23. OUR CONTACT DETAILS
Echeverria 3989 – 2 D
Buenos Aires City
1430 Cap Fed
ARGENTINA
MOBILE: +54 (9) 11 5122 5681
Anne Blanchard, CCRA, Executive Director,
anne@blanchardyasociados.com.ar, anne74@ciudad.com.ar
Paola Tapia, CCRA, Senior Associate
Lorena Levi, Bsc, CRA, Junior Associate