INTRIALS is a world-class, full-service Latin America CRO, based in Sao Paulo, Brazil, with offices in Argentina (Buenos Aires), Chile (Santiago) and Mexico (Mexico City). Since 1999, more than 70 satisfied clients have benefited from our understanding of our clients’ needs, our in-depth knowledge of each investigator competencies and capabilities of each site, our regulatory affairs expertise, our experience with many pathologies and procedures, and all those attributes that a CRO must master in order to ensure that client’s goals are achieved.

 

Intrials Mission

Our mission is to serve our clients, acting as an extension of their organization, focusing on success, exceeding their expectations, always in compliance with all ethical aspects and the highest quality standards

 

Intrials Vision

INTRIALS´vision is to be known as a reference in clinical research in Latin America for its ethical work with quality, effectiveness, innovation, reliability and focusing on results through the development of new treatments for the society.

 

INTRIALS´ DIFFERENTIATORS

1. The full-service REGIONAL CRO with complete infrastructure

• Full-time, bi-lingual and fully-loaded staff
  • Maximum education degree of INTRIALS staff: PhD
  • Minimum education degree of INTRIALS staff : University graduates in biology, pharmacy and medical sciences;

  2. Local, in-depth expertise

• Our founders and country general managers have combined nearly 150 years of living experience in the countries, in key positions with global pharmaceutical industries and global CROs;
• Throughout these years each one of INTRIALS’ executives has built a network of key relationships and in-depth understanding of the key success factors for clinical operations in each country – easy access to regulatory entities, best sites and investigators, medical societies, health institutions, medical schools, etc.

  3. Regional presence

• INTRIALS operates in Brazil, Argentina, Chile and Mexico.

  4. Strategic operations management

• This “local” extensive expertise makes INTRIALS more effective and efficient in all services related to clinical trials. We help develop clinical operations strategy to conduct trials in the most effective and efficient sites, exploiting the individual competencies of each country according to the requirements of each protocol.

  5. We take care of your challenges as you would - Satisfied clients

• Since our foundation in 1999, more than 40 leading pharmaceutical and biotechnology organizations have engaged INTRIALS services, including 12 out of the top 20 global pharmaceutical corporations and more than 20 biotechnology organizations. Most of our work is repeated business from our satisfied clients.

  6. Turnkey, on-demand services

Advisory & Consultancy Biological Material Management CRF Design Central Lab Logistics Clinical Monitoring Drug Accountability Data Management Feasibility Assessment Import and Logistics Investigator Relationship  Visit us: www.intrials.com.br

atient Recruiting Assistance Project Management Protocol Writing Regulatory affairs CTM - Secure Storage Statistics SOP Writing Translations Unblinded Monitoring Pharmacovigilance

 

Regional Directors & Managers

Claudio Ortega, MD Vice President, Clinical Research	More than 25 years experience in clinical research Medical degree from the Escola de Medicina da Santa Casa de São Paulo, Brazil, post-graduated in Genetics and Endocrinology from the New York State University, Syracuse, NY. Clinical Research Director, with responsibilities in Europe for phase III trials in dermatology and CNS at PRI RWJ (J & J) in Zurich. Medical Director of Schering Brazil, Dr. Ortega structured the clinical research department and brought to the country a number of phase III trials in oral hormonal and injectable contraception, HRT and hiperandrogenicity (hirsutism) with anti-androgen therapy.
Gizele Thame, BMD, PhD - Vice President, Administration & HR	10 years as Researcher of Sao Paulo State Government; Member of the Scientific Commission of Adolfo Lutz Institute, São Paulo, Brazil. Education - BA degree in Biomedical Science, Master in Public Health from USP and PhD in Public Health from University of Sao Paulo – USP Brazil. Created the open-house INTRIALS Continuing Education Program and the staff development training courses. Dr. Thame had 5 papers published on prestigious indexed publications as first author. She has also participated in the “Clinical Research Audit” training program according to FDA rules in Pennsylvania, USA.

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