ba 4 q 2010
TRANSCRIPT
Anne Blanchard, CCRA
Chief Executive Officer
Director of Clinical Operations
Meeting your quality expectations through our right mix of expertise
Our Mission is to provide tailor-suited services in
clinical research to meet our clients needs for success,
quality and efficiency:
– based on our experience and profound knowledge
of Latin American markets and regulatory affairs,
– ensuring compliance with industry practices,
international quality standards and local
requirements and
– with intense and continuous training policies that
guarantee personnel competence.
Our Vision is to be the leading CRO in Latin America
renowned for:
• Precise and meticulous work
• Reliable, qualified and accountable professionals
• Cost efficient services and reasonable timelines
Our Services
Pharmaceutical Products & Biologics
Stem Cells & Transplant
Medical Devices
GCP Capability audits
Quality System Set up
On the Job Training- Mentorship
Our Services
Medical Expert Sales Rep Training
Post Marketing Research Support
Market Research Support
Our Services
Clinical Research Operations
• Identification, selection and evaluation of Clinical Research Sites.
• Regulatory set up and Maintenance of a study.
• Clinical Research Monitoring according to ICH GCP
(including Rent a Monitor Program).
• Safety Monitor & SAE Expert review.
• Co-Monitoring and On the Job CRA training.
• Audit and Inspection preparation of sites.
Our Services
Quality Consulting
• Quality Interventions for Investigational Sites.
• SOPs set up for Clinical Research Sites.
• Facilities and Resources assessments for newly set up sites.
• On the job Study Coordinator Training.
• Legal & Regulatory advice (according to country level requirements).
• Capability audits and Study Specific Audits.
• Gap analysis assessments for compliance with MOH, GCP, etc.
Our Services
Sales and Marketing Support:
• Sales Forces Training
• Post Marketing Clinical Research Operations services, including:
– Protocol design, review or protocol writing
– Data Monitoring (according to ICH GCP)
– Safety Monitoring
• Market Research Support
• Studied Biology and English Language Teaching (ESL).
• Participated in set up of ICON Clinical Research offices inArgentina 1997.
• Worked as CRA in Ingenix (1999), Eli Lilly (2000), Abbott (2001),Sanofi (2004).
• Post Graduate as CRA at National Academy of Medicine.
• Started up B&A in 2003.
• Organized and Conducted several GCP and Regulatory trainingsin Clinical Research to over 400 attendees from Latin America.
• ACRP Certified as CRA in 2005 and recertified in 2007.Responsible for ACRP Certification Exam in Argentina in 2006and 2007.
• Author of one publication in GCP Journal, June 2005.
Anne Blanchard, CCRACEO- Clinical Operations Manager
Experience Highlights• Logistics Services Coordinator in charge of Importation, exportation and
distribution procedures for over 74 clinical research studies (in 1999- 2000).
• CRA in a International Multi center- industry sponsored study enrolling 5000
women with osteoporosis with a drug in a 10 year follow up to assess the
prevalence of breast cancer. 1100 women participated in Argentina only.
• CRA in an International Multi center, Industry sponsored study enrolling
more than 16000 subjects worldwide and over 1000 in Argentina Alone.
• Designed and Developed Quality System set up in a Phase I dedicated unit
in Argentina, passing one Independent Capability Audit and over 4
feasibility Assessment , 2 GCP Audits from Multinational Sponsors and one
MOH Inspection.
Anne Blanchard, CCRACEO- Clinical Operations Manager
• Graduated Biologist at University of Buenos Aires
• Post Graduated CRA at Bar Ilán University
• Worked as CRA at Hoechst Marion Roussel 1996-2000
• Worked as Senior CRA at Aventis 2000 -2004
• Participated in Staff Training Program at Aventis 2000 - 2001
• Worked as Senior CRA at Omnicare 2004-2006
• Associate at B&A since 2006
• Participated in City Parliament Health Commission as Author of Clinical Research Law.
• Organized and Conducted GCP and Regulatory training in Clinical Research as trainer at Fundación Cecilia Grierson.
• ACRP Certified as CRA in 2007.
Paola Tapia, BSc, CCRACOO- Regulatory Affairs Director
Experience Highlights• CRA in a International Multi center Industry sponsored study
enrolling 2400 patients with Type I Diabetes Mellitus withuncontrolled blood sugar to measure the frequency of severehypoglycemia. Trial comparing LANTUS algorithms.
• Senior CRA in a International Multi center- industry sponsored
study enrolling patients with Type II Diabetes Mellitus to compare
safety of insulin glulisine when comparing with insulin lispro.
• Senior CRA in International Multicenter Industry sponsored
studying Patients with Pneumonia or Aspiration of Gastric Contents
and Intubation/Ventilation/Oxygenation Impairment enrolling 1200
patients
Paola Tapia, BSc, CCRACOO- Regulatory Affairs Director
Cardiovascular
Hypertension (Phase III)
Atrial Fibrillation (Phase III)
Cardiovascular Risk & Osteoporosis (Phase III)
Cardiovascular risk and Diabetes (Phase III)
Congestive Heart Failure (Phase III)
Central Nervous System
Epilepsy (Phase III)
Alzheimer (Phase III)
Depression (Phase II)
Bipolar Disorder (Phase III)
Other Areas of Expertise:
Ophthalmology (Phase II)
Diabetes (Phase I and III)
Endocrino Metabolics (Phase III)
Dermatology (Phase III and IV)
Hemathology (Phase IV)
Stroke (Phase III)
Anti Infectives
Hepatitis C- (Observational, Phase I and II)
Hepatitis B (Observational)
HIV/AIDS (Observational, Phase I to IV)
Herpes Simplex (Phase III)
Community Acquired Pneumonia (Phase III)
Antibiotics for respiratory conditions
(Asthma, ADRS, COPD)
Vaccines
H1N1 Influenza (Phase IV)
Rotavirus vaccine (Phase III)
Meningococo B vaccine (Phase I)
Pneumonia vaccine (Phase III)
Lung Carcinoma Vaccine (Phase III)
Inflammatory
Hereditary Angioedema (Phase III)
Rehumatoid Arthritis (Phase II, III
observational)
Oncology
breast cancer (Phase III)
lung cancer (Phase III)
melanoma (Phase III)
hepatic carcinoma (Phase III)
Flexible capabilities for operations
Study Coordinators
Investigators
Project Managers
CRAs
Medical Experts
B&A scope of work is
primarily Argentina,
Brazil and Chile.
However B&A is
presently involved in
projects in other Latin
American Countries
such as Mexico or
Uruguay.
Operational Scope
Our Clients
31%
6%10%3%
22%
28%
Pharmaceutical Companies
Biotech Companies
Device Companies
Academic Res. Organizations
Clinical Sites
CROs
• To expand services in Latin America through the
consolidation of our regional network, under the
leadership of B&A.
• To build up a solid yet flexible and efficient
organization.
• To place emphasis on quality and training in Clinical
Research in the execution of clinical trials.
Our Perspective
Because we have competitive service fees and time
efficient procedures without compromising quality.
Because we have a resilient structure to cope with
regulatory and technologically changing environment
Because B&A partners, associates and all its human
resources make a personal commitment to the work we
undertake and account for.
Why choose us
Because we have motivated, dedicated and focused
professionals with up to date training.
Because we are supported by positive references from
Sponsors and Investigators that have worked with us in
previous studies.
Because our professional relationship with Regulatory
Agencies in Argentina, Brazil and Chile allows us to
overcome regulatory obstacles through knowledge exchange
and open communication.
Why choose us
Blanchard & Asociados
Echeverría 3989 – 2 B
Buenos Aires
C1430BTL
ARGENTINA
Blanchard & Associates1172 South Dixie Hwy
Suite# 442
Coral Gables
FL33146
USA
TEL: +54 11 4553 2682/ 4554-9346
FAX: +54 11 4554 8933
Anne Blanchard, CCRA, CEO
www.blanchardyasociados.com.ar
Find out more, contact us!