INTRIALS PESQUISA CLÍNICA LTDA

WE WORK AS AN EXTENSION OF YOUR ORGANIZATION IN LATIN AMERICA,

TO HELP YOU BRING PRODUCTS TO MARKET FASTER!

INTRIALS is a world-class, full-service LATIN AMERICA CRO, founded in Brazil in 1999 by scientists with international work experience and nearly 80 years of combined experience in clinical research, who have been dedicating time and resources to build a perfection-driven organization.

Since our foundation we have been building a history of successfully-conducted projects that have either met or surpassed our clients' goals. We have been providing full turnkey and "on demand" Clinical Research services to more than 40 international clients including 8 out of the top 20 global pharmaceutical companies, numerous biotechnology organizations, medical devices corporations, global CROs and international logistics organizations, on 125 trials in 19 areas.

INTRIALS has always achieved high scores at all audits conducted by international clients. This is a result of our early detecting potential problems, contingency planning and detailed regular internal audits, that ensure corrective measures are quickly implemented.

THE 7 REASONS TO SELECT INTRIALS IN LATIN AMERICA

1. THE FULL-SERVICE LOCAL CRO WITH COMPLETE INFRASTRUCTURE

• INTRIALS 500 m² Head Office is located in Sao Paulo City, Brazil, with complete on-site infrastructure for storage and distribution of clinical trial materials fully controlled 24/365;
• Full-time, bi-lingual and fully-loaded staff
  • Minimum education degree of INTRIALS staff : University graduates in biology, pharmacy and medical sciences;
  • Maximum education degree of INTRIALS staff: PhD
• Dedicated team for all import and regulatory affairs activities.

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. EASY ACCESS TO ALL EXECUTIVES - NO ORGANIZATIONAL BARRIER
When engaging INTRIALS you will face no organizational barrier – our key management work in close contact with you as an extension of your clinical development team in Latin America to ensure that your project is conducted with PERFECTION.

4. REGIONAL PRESENCE
INTRIALS operates in Brazil, Argentina, Chile and Mexico.

5. 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.

6. FLEXIBILITY AND RESPONSIVENESS

• Flat organization, faster decision-making;
• We work with our clients as if we were an extension of their own organization

7. 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 8 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.

CONTACT US to access a presentation about the region and to learn more about how INTRIALS can assist you conduct studies in Latin America.

WE TAKE CARE OF YOUR CHALLENGES AS YOU WOULD!

INTRIALS is headquartered in the heart of Sao Paulo City, Brazil, in a 500m² facilities with full CTM import, storage and distribution area. At INTRIALS your needs are embedded throughout our organization. Our full-time, bilingual staff embrace your challenges to ensure we deliver Clinical Research Excellence as no-one else will.

This vision has paved INTRIALS success and has been influential to our growing through clients' referrals and repeated businesses. More than 40 satisfied international clients have engaged our services in 125 Phase II to Phase IV and IND trials, in 19 therapeutic areas, including 34 projects with complete clinical monitoring and outstanding performance.

THERAPEUTIC AREAS

Oncology, Cardiology, Cardiovascular, Infectious Diseases, Respiratory, Vaccines, Central Nervous System, Endocrinology, Gastroenterology, Gynecology, Neonatology, Hematology, Nuclear Medicine, Dermatology, Ophthalmology, Rheumatology, Urology, Surgery, Devices.

CONTACT US to access a presentation about the region and to learn more about how INTRIALS can assist you conduct studies in Latin America.

Clinical Monitoring

The Clinical Research Associates at INTRIALS are full-time bilingual employees, equipped with laptops, mobile phones and internet. They are not only constantly trained in Best Practices of Clinical Research but also PROVIDE TRAINING to other clinical research professionals as instructors of the traditional INTRIALS Annual Workshop – Clinical Research Best Practices.

Our CRAs have the experience and technical competence to monitor the conduction of simple and complex researches, the motivation and the essential interpersonal and communication skills to productively manage the relationships of all parties involved in the study.

Project Management

INTRIALS has a unique process-based management approach. Our project management group receives continuous training in accordance with the Project Management Body of Knowledge (Project Management Institute), to ensure that your project fully provides for the good clinical practices, SOPs, budget and medical aspects.

From the start to the completion of the clinical research, a project management executive will be assigned to your project to ensure the proper interaction of the various parties in such a way that overall risk is reduced, and the ultimate goal of Clinical Research Excellence is achieved.

Regulatory Affairs

The accumulated experience of INTRIALS, as attested by our clients, makes it possible to obtain regulatory approvals more effectively and efficiently. How do we do it?

• Deep knowledge of the legislation and the requirements of health organizations;
• Meticulous planning and preparation of study documents, project by project;
• Close follow-up and responsiveness to requirements from all levels of approval;
• Clearness of the Informed Consent to make it easily understood by the patient.

Import, Storage And Distribution

INTRIALS is authorized to store and handle any type of Clinical Trial Materials, including biologic and controlled substances. At INTRIALS the CTMs (clinical trial materials) are handled by a department entirely dedicated to all import processes and issues, acting with responsiveness and providing total assistance to both the sponsor and the investigators.

INTRIALS IMPORT & STORAGE STRUCTURE:

• Conformity to GCP and GMP norms;
• Approved to store and manage controlled substances;
• Conformity to INTRIALS’ internal SOPs;
• Separation by client and by trial;
• Restricted and controlled access;
• Remote temperature monitoring;
• Backup electricity generator;
• Automatic temperature recording, each 4 hours;
• Humidity recording and control;
• Security system against robbery, sunlight, vandalism and insects;
• Fire protection;
• 24-hour video recording.

Selection And Qualification Of Study Centers

INTRIALS has a profound knowledge of the clinical research environment and its players in Brazil. This knowledge is accrued in a database that is continuously updated through the experience we have acquired from concluded studies and services, from our close relationship with health professionals and government agencies, indications from sponsors, and data collated from our continuous surveys.

We can, therefore, easily identify those investigators whose experience, competencies and current patients better meet your trial requirements. INTRIALS study center selection process is designed to meet your study profile and to maximize data quality, project budget and cycle time.

Quality Assurance

At INTRIALS problems are predicted, not detected. We audit the trials as from the first stages of the development, to identify potential problems and develop corrective measures to prevent interruptions and the costs associated with not anticipated problems. Our staff possesses the required expertise and is frequently trained in QA and ICH guidelines, so that you receive complete and customized services to ensure data accuracy and Clinical Research Excellence.

INTRIALS Quality Assurance services encompass:

• Internal System of Quality Assurance;
• Contract audits;
• SOPs preparation and revision.

Protocol And CRF Design

Protocol and CRF quality is decisive for the subsequent stages. INTRIALS' staff becomes fully involved in developing relationship with our clients and in nurturing the partnership. This aspect, together with our experience and our Excellence-driven culture, creates an environment that favors the construction of the project intelligence, concentrated in the stage of Protocol and CRFs Elaboration.

CONTACT US to access a presentation about the region and to learn more about how INTRIALS can assist you conduct studies in Latin America.

In the light of the vast, untapped opportunities in Latin America, and stimulated by our clients that required that we fully managed their projects in all Latin America countries, INTRIALS initiated expansion to other Latin America countries in 2006.

INTRIALS is headquartered in Sao Paulo City, has offices in Santiago do Chile, and Mexico, and is beginning operations in Argentina. At INTRIALS you are always in contact with the key Management, as we understand that time is money and work with you as an extension of your clinical development team in Latin America.

CONTACT US to access a presentation about the region and to learn more about how INTRIALS can assist you conduct studies in Latin America.

INTRIALS - HeadOffice & Latin America Central Operations
R. Joaquim Floriano, 913 – 2^o - Itaim Bibi - SP - Brazil - 04534-013
Tel: (55-11) 3073.6770 | Fax: (55-11) 3073. 0300
business@intrials.com.br

CLAUDIO ORTEGA, MD - Vice President, Clinical Research

Co-founder and Vice President, Clinical Research Dr. Ortega brings to INTRIALS, more than 25 years experience in clinical research. His areas of expertise include Oncology, Dermatology, Epilepsy, Cardiovascular, Antibiotics and Women’s Health.

Dr. Ortega has dedicated his career to the clinical research, which started 30 years ago when he conducted a phase IV study with the oral anti-diabetic compound dibenclamide (Daonil). During 1974 and 1975, he was a post-graduate fellow at the New York State University in Syracuse, when he wrote the chapter Mucopolissacaridoses in the textbook “Endocrine and Genetic Diseases of Childhood and Adolescence”, edited by Lytt Gardner. During the 80’s while Medical Assistant at Merrell-DOW, Dr. Ortega coordinated in Brazil several investigations with colestiramine and probucol, both anti-lipemic substances.

As the 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. In 1988 Dr. Ortega jointed PRI RWJ (J & J) in Zurich as Clinical Research Director, with responsibilities in Europe for phase III trials in dermatology and CNS. In 1995, when he returned to Brazil, Dr. Ortega became COVANCE representative in the country, and managed anti-infective studies in Brazil for one of the top 5 global pharmaceutical companies until 1999, when he founded INTRIALS with two other partners.

At INTRIALS, Dr. Ortega is responsible for planning, directing and supervising clinical research programs, as well as providing consultation for potential safety issues or medical concerns related to the clinical trials.

Dr. Ortega has a medical degree from Escola de Medicina da Santa Casa de São Paulo, Brazil and a post-graduate degree in Genetics and Endocrinology at New York State University, Syracuse, NY. He is the author of the textbook “Genética Médica” published in Portuguese for Brazilian medical students, and wrote several articles on clinical genetics published in indexed magazines.

SERGIO LOPES, PharmD – Vice President, Regulatory Affairs

Co-founder and Vice President, Regulatory Affairs, Dr. Lopes brings to INTRIALS, more than 25 years experience in all key areas of product development and marketing with ethical and OTC products, nutritionals and medical devices, having planned, directed and supervised studies in a number of therapeutic areas such as Anti-infectives, Cardiovascular, CNS, Dermatology, Hematology, Infectious Diseases, Ophthalmology, Urology, Oncology, Respiratory, Rheumatology and Vaccines. Prior to founding INTRIALS, Dr. Lopes was General Manager of Bristol-Myers Squibb, Peru, and Marketing Director of Bristol-Myers Squibb, Brazil. His in-depth knowledge of the health care and regulatory environment in Brazil are key contributions to INTRIALS’ successful track record in obtaining quick regulatory approvals and record time in import clinical supplies.

At INTRIALS Dr. Lopes is responsible for all Regulatory Affairs and Drug Supply processes.

Dr. Lopes received a Degree in Pharmacy and Biochemistry from USP – Universidade de São Paulo, Brazil, a PharmD in Industrial Biochemisty and Pharmacy also from USP – Universidade de São Paulo, Brazil, and have attended several Clinical Research courses and meetings.

GIZELE THAME, BMD, PhD - Vice President, Corporate Development & Administration

Co-founder and Vice President, Corporate Development & Administration, Dr. Thame brings to INTRIALS 10 years experience in basic research and significant educational background. This expertise supported her to develop the 23 courses in Clinical Research at the INTRIALS Continuing Education Program. These courses had contributed to the outstanding professional level of INTRIALS’ staff. Prior to co-founding INTRIALS, Dr. Thame held several positions as researcher of Sao Paulo State Government. She also held management positions in administration and finance at family-owned businesses, and was Member of the Scientific Commission of Adolfo Lutz Institute, São Paulo, Brazil.

At INTRIALS, Dr. Thame is responsible for Finance and Administration. Her activities also encompass the HR and Personnel Development areas.

Dr. Thame received her Bachelor Degree in Biomedical Science from Universidade Metodista de Piracicaba, Brazil, her Masters Degree in Public Health from USP - Universidade de São Paulo, Brazil, and her PhD in Public Health from USP - Universidade de São Paulo, Brazil. 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

Contact Information

INTRIALS PESQUISA CLÍNICA LTDA
Maria Regina Visani, MBA, Business Development
Rua Joaquim Floriano, 913 2o andar conjuntos 21/22
Sao Paulo, SP CEP 04534-013 Brazil
Phone: (55-11) 3073.6770
Fax: (55-11) 3073.0300
E-mail:

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