b&a_may 2015 showcase for linkedin
TRANSCRIPT
Corporate Presentation MAY 2015
Anne Blanchard – CEO
Leading CRO in Latin America renowned for:
Precise and meticulous work.
Reliable, qualified and accountable professionals.
Cost efficient services in reasonable timelines.
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
OUR VISION
Provide tailor-suited services in clinical research to meet our clients needs for
success, quality and efficiency:
Based on experience and profound knowledge of Latin American markets and regulatory affairs.
Ensuring compliance with industry practices, international quality standards and local requirements.
Intense and continuous training policies that guarantee personnel competence.
OUR MISSION
“Building bridges of knowledge in clinical research with all parties involved
through professional effective communications”.
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
OUR PHYLOSOPHY
OUR PERSPECTIVES
Responsibility and commitment.
Ethics and transparency.
Professionalism.
Continuous Improvement.
OUR VALUES
To expand services in Latin America through the
consolidation of our own companies in the region.
To build up a solid yet flexible and efficient
organization.
To achieve quality data in Clinical Research through
the execution of clinical trials.
Clinical Research Operations
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
OUR SERVICES
Clinical Research Monitoring
according to ICH GCP.
• We work together with site study
team, providing guidance and
training.
• Our staff is fully bilingual and
count with modern
communications systems.
• We undergo continuous training as
per our company`s SOPs.
• We provide efficient on site and
remote monitoring.
Regulatory set up and Maintenance of a study. • Detailed step by step project
planning and careful preparation of
study documents in competitive
timelines.
• Knowledgeable review Informed
Consent following local
requirements and local language
expressions .
• Efficient follow-up to all regulatory
instances, with permanent rapport
with our clients.
• Deep and updated awareness of
health legislation and research
related requirements.
Regulatory Consulting
regarding Clinical Research
Activities.
• We can help you decide your
strategy and identify opportunities
and challenges regarding your
research plan in Latin America.
Clinical Research Operations
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
OUR SERVICES
Project Management.
• Overall Study Management,
budget control, data integrity and
timeline tracking.
• Periodic reporting to our clients,
vendor management and
recruitment oversight and advice.
• Development of study specific
plans.
• Investigator contract development
and Payments Management as
needed.
Identification, selection and evaluation of Clinical Research Sites. • Our periodically updated database
has over 4500 active
Investigational sites and
throughout Latin America, together
with our feasibility information and
experience with the sites .
• We offer a shortlist of which sites
to chose from and which
Investigator has the experience
and the performance for each
study.
Safety Monitor & SAE Expert
review .
• We count with diverse Clinical
Research experienced physicians
that review safety data and serve
as a connection between our
clients and sites.
Co-Monitoring and On the Job
CRA training.
• Contract Therapeutic Area Lead
or Therapeutic Research
Liaison. Co-Monitoring to help
clean study data backlog and
CRA Training on site.
Clinical Research Consulting
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
OUR CONSULTING SERVICES
Clinical Research Consulting for
Investigational Sites:
• Overall support during study progress, including training, CQI and ongoing advice.
• Design development and implementation of Clinical Site SOPs.
• Ongoing Quality Management Support for Clinical Research Sites and Site.
• Improvement programs.
Quality Assurance services: • QA GCP Audits for Clinical Research Sites.
• Needs Analysis and preparation for ANVISA
Accreditation of Clinical Pharmacology Units.
Recruitment Intervention services: • Needs Analysis for studies with low or unsuccessful
recruitment.
• Development of Tools and recommended Interventions to identify issues revert situation and reach the projected recruitment targets .
Registration of Phramaceuticals and
Medical Devices in Latin America:
• Our network of experts that help our clients
approach registration and commercialization of their products in the Region.
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
OUR TEAM
Our Senior Management Team includes:
• CEO and Clinical Operations Officer.
• Chief Scientific Officer
• Country Management in all of our countries
• CFO/Finance Manager
• Legal Affairs
• Regulatory Affairs
• Training Management
• Quality Assurance
Anne Blanchard, Country Manager, Argentina
Carlos Zala, Medical Head
Cecilia Vidart, Finance Manager
Eugenio S. Meneses,
Country Manager Chile
Joyce Marinho, Country Manager, Brazil
Sergio Godoy, Manager Medical Devices
Anti -Infectives
Cardiovascular
Central Nervou System
Dermatology
Oncology
Ophthalmology
Immunology
Vaccines
Endocrino - Metabolics
Other Indications
OUR TEAM EXPERIENCE
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
ANTI INFECTIVES Chagas Disease Hepatitis C Hepatitis B HIV / AIDS Herpes Simplex Community Acquired Pneumonia ADRS Influenza
CARDIOVASCULAR Abdominal Aorta Aneurism Atrial Fibrillation Cardiovascular Risk & Osteoporosis Cardiovascular Risk & Diabetes Congestive Heart Failure Coronary Lesions Hypertension Heart Failure
CENTRAL NERVOUS SYSTEM Epilepsy Alzheimer Depression Bipolar Disorder Multiple Sclerosis Anxiety Disorder Smoking Cessation Adrenoleukodystrophy Spasticity
DERMATOLOGY Acne Vulgaris Actinic Keratosis Psoriasis Cutaneous Leishmaniosis Melasma Tinea pedis Impetigo
IMMUNOLOGY Rheumatoid Arthritis Juvenile Rheumatoid Arthritis Hereditary Angiedema
ONCOLOGY Breast Cancer Cervix Cancer Chronic Myeloid Leukemia Colorectal Cancer Gist (QOL) Lung Cancer Melanoma Prostate Cancer Head & Neck Cancer
OPHTHALMOLOGY Uveitis Glaucoma Keratoconjunctivitis
VACCINES H1N1 Influenza Respiratory Syncytial Virus Hookworm
ENDOCRINO-METABOLICS Osteoporosis Hipercholesterolaemia Diabetes M. Type I and II Early Puberty
OTHER INDICATIONS Stroke COPD Von Willebrand Disease Renal Impairment Traumatic Brain Injury Primary Biliary Cirrhosis Hemophilia
OUR TEAM EXPERIENCE
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
_ Studies involving pediatric population CRO Services under B&A B&A Clinical Operation Management Team Experience
8%
19%
42%
31%
Studies
Phase I Phase II Phase III Phase IV
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
EXPERIENCE BY STUDY PHASE
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
CONSULTING EXPERIENCE
PharmacovigilanceSOPs
GCP Quality Systems/Training
Market ResearchSurveys
PharmacologyUnit/BioequivalenceOperations
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
18%
15%
14% 10%
2%
17%
2% 1%
3% 15%
3%
Anti Infectives
Cardiovascular
Central Nervous System
Dermathology
Immunology
Oncology
Opthalmology
Respiratory
Diagnostics
Other Indications
Vaccines
EXPERIENCE BY THERAPEUTIC AREA
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
OUR CLIENTS
PharmacovigilanceSOPs
GCP Quality Systems/Training
Market ResearchSurveys
PharmacologyUnit/BioequivalenceOperations
33%
12% 16% 10%
29%
PharmaceuticalCompanies
Biotech Companies
Medical DeviceCompanies
Academia/NGO
CROs
We attended as speakers at ACRP meeting in San Antonio and RAPS meeting in Austin,
sharing our knowledge and advice on the region and operational aspects on how to set up
and conduct studies.
For fourth consecutive year, we have been invited to participate as guest Editors for
Chapter 19th from the GCP Q&A guide edited by Barnett International. We undertake this
appointment with great responsibility and pride and look forward to keeping our readers up to
date with trends and requirements in the region.
In December, we have entered an Strategic Alliance Partnership with ACRES, promoting
excellence in Clinical Research in our Region, and hoping to collaborate with excellence
standards that are meaningful and achievable at the same time.
During 2014 we retained all our staff and we have increased two fold our CRA and
Project Management force, together with continuous improvement in our Quality and
Training systems.
During 2014 we were awarded 12 projects in oncology, liver diseases, metabolic, gene
therapy, neuromuscular disorders and dermatology, gene therapy and coagulation
disorders while we continue with 8 ongoing studies in infectious diseases (including HIV and
vaccines), cardiovascular, risk pregnancy prevention and nephrology.
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
B&A HIGHLIGTS
2014
During 1st Quarter 2015, we have been awarded 3 projects including infectious diarrhea
treatment in pediatric population, spasticity treatment surveillance and early puberty study.
“2015 Business Plan” for continuing improvement of our companies and services in the
region to improve our presence and acquire new offices and expertise.
During the Annual ACRP meeting in Salt Lake City we received the “2015 Outstanding
Leadership Award by a CRA”.
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
B&A HIGHLIGTS
2015
The Outstanding Leadership in Clinical Research
by a CRA Award
Recognizes a member who is active as
a Clinical Research Associate (CRA) and
has made exceptional leadership/practice contributions that
have furthered the vision and mission of ACRP
to promote excellence in clinical research.
Coral Gables (Florida)
Mexico
Colombia
Fortaleza/Sao Paulo (Brazil)
Buenos Aires (Argentina)
Santiago de Chile (Chile)
We are also experienced in providing
services in Peru, Venezuela, Guatemala,
Paraguay, Panamá, Bolivia and Uruguay.
OUR LOCATIONS
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”
We offer services in Latin America through a group of
companies of B&A Ownership:
www.blanchardyasociados.com
Blanchard & Associates LLC
CONTACT US
“MEETING YOUR QUALITY EXPECTATIONS THROUGH THE RIGHT MIX OF EXPERTISE”