South American Services & Experience
South America is globally recognized for its enrollment potential and the high quality of study data obtained. In addition, regulatory enforcement bodies, quality investigators, ethics committees ensuring patient safety, proactive Good Clinical Practice (GCP) policies, and large research-naïve populations have been cited as contributing to the explosive growth of clinical trial management in this region.
Best practices lead to better outcomes
- Don’t underestimate the length of time it will take to go through the international regulatory and import process. You must also plan for time to establish an internationally legalized power of attorney and regional localization.
- Due to the nature of the regulatory process in South American countries and the cycle time to trial approval it is vital to submit documentation correctly the first time.
- Take time to understand how the sponsor’s representatives like to work and what they prefer as a communication channel, especially when considering language and culture differences.
- It is particularly important to have someone local involved with the trial who understands and can address regional issues and how cultural differences could affect participation.
At Clinipace, our goal is your success in all steps of the projects and programs we run, resulting in high quality data and compliance with contracted scopes and planned timelines. Clinipace is committed to ensuring your success by providing:
- local expertise in the regulatory field, including liaising with regulatory agencies and ethics committees
- dynamic and specialized Project Management and Site Management teams
- a unified clinical monitoring team, managed regionally as part of our Global Clinical Operations structure
- regional medical monitors familiar with local standards and derived issues investigators may face
- hassle-free communication, 24 hours a day/7 days a week, with Spanish- and Portuguese-speaking professionals in your local time zone
To be successful in South America, local resources have a greater impact. If you’re ready to learn more about working in South America or how we can help with your upcoming program, contact us to speak with one of our regional experts.
Looking for help in South America?
- Ofelia Rodriquez Nievas, MDSr. Director, Project Operations; Medical Affairs DirectorOfelia Rodriquez Nievas, MDSr. Director, Project Operations; Medical Affairs Director
With almost 30 years of experience as a Medical Oncologist, Ofelia has been on both sides of the clinical research counter – as an investigator while she was still practicing, and then on the clinical operations and medical affairs side after joining the CRO industry over a decade ago.
Her main areas of expertise include oncology and conducting clinical trials in Latin America.
Ofelia says: “At Clinipace, we go to work every day with the goal of pursuing new therapies through collaboration in order to bring better treatment options to those who need them.”
- Sandra Schefler, RPh, MBASr. Director, Project OperationsSandra Schefler, RPh, MBASr. Director, Project Operations
Sandra has worked in the clinical research and pharmaceutical industry for nearly 20 years and has significant experience conducting clinical trials in oncology, cardiology, and rheumatology. During this time, she has developed skills in quality control, leading the scientific information department on supporting internal and external clients and being a part of the global core team in clinical trial operations.
Sandra holds a bachelor’s degree in pharmacy and subsequent specialization in industrial pharmacy as well as an MBA from Faculdades Getúlio Vargas.
Sandra says: "Respect to regional and country specific culture in addition to a constant and fluid effort of supporting our local experts aligned with a global innovative workplace scenario at Clinipace are key factors to achieving excellence in our day-to-day deliverables within clinical operations and project management.”
- Pablo LaboniaProject ManagerPablo LaboniaProject Manager
Pablo obtained his degree as a Biochemist with specialization in Biotechnology at the University of Buenos Aires (UBA). He has been in the clinical research industry for more than 15 years accounting for extensive experience working as a CRA and during the last eight years as Project Manager, both positions mostly in the oncology field.
As a clinical operations professional, he has managed phase I to phase IV local (Argentina), South America (Peru, Mexico) and global clinical trials (USA, European countries and APAC region).
- Fernanda Pimentel, RPh, MBAClinical Trial Applications Manager, Latin AmericaFernanda Pimentel, RPh, MBAClinical Trial Applications Manager, Latin America
Fernanda is a biochemical pharmacist who has her MBA in Project Management. She has nearly a decade of experience in clinical research, starting as CRA I and CRA II while developing her skills to Regulatory Affairs and Site Start-up coordination since 2012. Fernanda has experience with Phases I through III clinical trials from feasibilities and start-up to closeout. She has experience in oncology, rheumatology, cardiology, hypertension, vaccine and allergy therapeutic areas.