Clinical Research Organization (CRO) and Regulatory Affairs Consultancy in Latin America
We lead innovation that changes lives
Clinical Research – CRO
- We help you to develop any stage
of a clinical trial
- Regulatory and legal representation
- Regulatory consulting
- Implementing of 24/7 pharmacovigilance systems
- Sanitary registration of products
- Regulatory consulting
An expert partner in Latin America
We provide services to the pharmaceutical and biotechnology industry for the development of clinical trials from Phase I to IV. Also, we guide companies through the challenges related to regulatory issues within the pharmaceutical market.
Based in Chile, we have conducted studies throughout Latin America for the most important multinationals with a 100% committed team, senior researchers, exhaustive control of all processes and strategic alliances throughout the region.
Our experience and local knowledge will benefit your project, with cost-effective and high-quality management.
Experience in clinical trials (chronic pain, infectious diseases, diabetes, hematology, oncology, respiratory/pulmonary, reumathology) and vaccine studies (COVID-19, Influenza).
We put you ahead of your competition with our expertise and partnerships in North and South America.
Working together to overcome the pandemic
Largest COVID-19 vaccine trial in Chile with
Clinical trial in Chile with inhaled vaccine
We are a Contract Research Organization (CRO) and regulatory consultancy dedicated to providing services to the pharmaceutical and biotechnology industry
for the development of clinical trials from Phase I to IV.
Our solutions and capabilities
Site selection, clinical trial applications, monitoring (on-site, remote), project management, mobile nurses, medical monitoring, IMP logistics
Regulatory and Clinical Consultancy
IoR for clinical trials, strategic input on clinical development and regulatory pathways (sanitary registry, pharma, bioequivalents, others)
Sample size calculation, SAP development, statistical analysis, consulting
Study design, protocols, IBs, medical/technical reports, study reports manuscripts
eCRF development, IWRS, e-Diary/ePRO, data management
Real World Evidence
RWE strategy and implementation, Direct-to-Patient studies
e-TMF-e-ISF, CTMS, risk-based study execution
Implementation of 24/7 pharmacovigilance systems
Site qualification and support on IITs
Study documents, submissions, data management, supplies, project support, statistical analysis
What we do in regulatory consulting
- Representation as Technical Direction of companies to the regulatory authority of Chile (Institute of Public Health)
- Regulatory affairs intelligence
- Health registration – Bioequivalents
- Management of importation with the Chilean regulatory authority (Institute of Public Health).
- Implementation of quality management systems (GMP, GLP)
- Implementation of 24/7 pharmacovigilance systems
We offer global presence through our strategic partnerships with local players
USA: CRO Partner
Mexico: CRO Partner
Chile: Headquarters (Santiago)
Argentina: CRO Partner
Peru: CRO Partner
Colombia: CRO Partner
Chile is an excellent location for clinical research
Chile is a hub of innovation and research in Latin America given its competitive advantages in clinical research
- Research centers of excellence with extensive experience in academia that generate international trust
- Clinical research culture due to more than 30 years of experience developing clinical studies
- Globally competitive regulation
- Scientific ethics committees accredited by international standards
- World-class healthcare infrastructure
- Wide network of experienced researchers
Get to know our CEO
BOPAL was founded in 2019 by Pablo García, given his passion for clinical research, personal growth, entrepreneurship, innovation, technology and designing creative business models to solve problems.
With more than 13 years of experience in the international pharmaceutical industry -in clinical research, pharmaceuticals, medical devices and commercial areas- Pablo is a regulatory expert, pharmacist graduated from the Pontificia Universidad Católica de Chile, Master in Marketing and Commercial Management from the Universidad
Former Regulatory Manager of the Clinical Studies Unit in Sanofi Chile.
Pablo is BOPAL's CEO
What our clients and partners say about us
“Working with BOPAL has been an honor as they are a highly committed, dynamic and very professional company. We have worked closely in one of the most complicated times for Clinical Research and for the world, achieving to consolidate a working brotherhood between two countries”
Annette Ortiz-Austin | Director, EPIC CRO, Mexico
“I am very happy to have this opportunity to work with BOPAL in these last months. The management team was able to understand the instructions very well and carried them out wisely. They have a well-trained team and demonstrate plenty of experience and knowledge to implement the tasks”
Haipeng Yang | Associate Global Project Manager, Tigermed Group, Canada