1 1 8th LATIN AMERICAN CONGRESS ON CLINICAL RESEARCH BUENOS AIRES 2011 Latin America Role in Worldwide Clinical Research Buenos Aires, - October 19-21, 2011 Welcome to the top regional academic forum on Clinical Research in Latin America, aimed at fostering the integration of professionals in the field, looking to fully develop our potential in the global scope of Clinical Research. PROGRAM
3 3 Dear colleagues, On behalf of the Organizing and Scientific Committee of the 8th Latin American Congress on Clinical Research we are pleased to welcome you in Buenos Aires to share this meeting, the top regional academic forum on Clinical Research in Latin America, co-sponsored by the Drug Information Association (DIA) and the Sociedad de Medicina Farmacéutica (SAMEFA). In three days of intensive academic activity, we look forward to accomplishing our goal of fostering the integration of professionals involved in the development and life cycle management of pharmaceuticals, medical devices, and related products from all over the region, looking to fully develop our potential in the global scope of Clinical Research. We hope you enjoy meeting colleagues and friends from all over the region at this year s meeting. The program committee has designed an agenda aimed at presenting attendees a state of the art educational experience with conferences and round tables guaranteed to offer something of interest for everyone. Two engaging pre-congress tutorials are the initial offer on Wednesday, October 19th, followed by two days where plenary and concurrent sessions will cover a broad spectrum of topics, presented by a faculty of experts from almost all Latin America and the US. Our special thanks to all guest foreign speakers for coming to to share with us their knowledge and expertise, and to all local faculty members as well. Please, do not miss the commercial exhibition where over 30 companies will be glad to share with you their products and services. We thank all our sponsors for their contribution, which has been essential to succesfully organizing this Congress. We hope you find Buenos Aires a delightful destination, and besides academic activities, professional and social networking, you find some time to enjoy the attractions of a very international city with a Latin American flavor. We wish you a productive, educational, and pleasurable stay in Buenos Aires. Welcome! Juan Carlos Groppa, MD Congress Chairperson Hugo Cohen Sabban, MD Scientific Committee Chair
4 4 ORGANIZING AND SCIENTIFIC COMMITTEES INTERNATIONAL COMMITTEE CONGRESS CHAIRPERSON Juan Carlos Groppa, MD Past President, SAMEFA (Argentine Society of Pharmaceutical Medicine) Medical Affairs Manager. Laboratorios Bagó S.A., SCIENTIFIC COMMITTEE CHAIRPERSON Hugo Cohen Sabban, MD President, SAMEFA (Argentine Society of Pharmaceutical Medicine) CEO, CRO BIOSOLUTION, SCIENTIFIC COMMITTEE Sebastián Batagelj, MD Medical Advisor, Laboratorios Bagó, Mario Boskis, MD CEO Activa CRO, Buenos Aires, Daniel Ciriano, MD Medical Director - Roche Andrea Costantini, MD Medical Advisor, Phoenix Laboratories, Luis Collia, MD Medical Director, Laboratorios Craveri, Cecilia D Antuono, PhD Manager of Site Management- Bristol Myers Squibb Wanda Dobrzanski, MD Medical Director, Medical & Scientific Affairs, Respiratory and Infectious Diseases, i3 Global, Rosana Felice, MD Medical Director, & Southern Cone, GlaxoSmithKline, María Jimena Fernández Bartolomé, MD Clinical Studies Monitor, Pharma Division, Medical Department, Productos Roche Gustavo Fischbein, MD Medical Director, Osmotica Pharmaceutical, Lic. Pablo Hammerschmidt Regional Director, Clinical Operations, ICON Clinical Research, Gabriela Kivelevitch, MD Medical Advisor, Laboratorios Phoenix, Daniel Mazzolenis, MD MBA Director Clinical Development, Hematology/Oncology Site Head - INC Research Gerardo Mendez Ciancaglini, MD Product Information & Consumer Service Department Head, Laboratorios Bagó S.A., Sandra Mercurio, MD Medical Director & Lead Nominated Signatory, AstraZeneca, Luis Pliego, MD Regional Medical & Regulatory Affairs Manager, Janssen-Cilag, Luis Ramirez, MD Regional Head Clinical Operations for Latin America, Boehringer-Ingelheim, Rosa M. Scuteri, MD Medical Manager, Trasplant and Special Lines, Pfizer, Daniel Vazquez, MD Senior Director Regulatory Affairs, Quintiles S.A., Silvia Zieher, MD Executive Director, Latin America Operations, INC Research, Vanessa Cohen, MD Medical Manager, GSK Mexico Past President, AMEIFAC (Association of Pharmaceutical Medicine Specialists), México Sergio Guerrero, MD President and CEO, Accelerium Research, México Chairperson, DIA Provisional Advisory Council of Latin America (pacla) Gustavo Kesselring, MD Executive Director, ViS Research Institute, Brazil Marlene Llópiz Aviles President, AMEIFAC (Association of Specialists in Pharmaceutical Medicine), México Joao Massud Filho, MD Professor, Federal University of Sao Paulo, Brazil Charles Schmidt, MD VP Sales & Marketing, Clinical Operations, Eurotrials Stephen Sonstein, MD Director, Clinical Research Administration, Eastern Michigan University María Alejandra Vazquez Gragg, MD Global Head, Safety and Pharmacovigilance, Research Triangle Institute International Marcelo Vianna de Lima, MD, MBA Medical Director, Latin America, GE Healthcare - Medical Diagnostics, Brazil President, SBMF (Brazilian Society of Pharmaceutical Medicine) Juan Luis Yrivarren, MD Director, Centro Investigación Ricardo Palma, Perú
5 5 PROGRAM AT A GLANCE Wednesday, October 19th 7:30 am - 04:00 pm Registrations 09:00 am - 06:30 pm Concurrent Congress open to all DIA Pre-congress Tutorials Congress Attendees Room Amazonas Room Río Paraná Tutorial 2: Quality Assurance: Tutorial 1: Risk Project 2do Congreso Argentino de Medicina Practical tools for the Best Management Farmacéutica (SAMEFA) Clinical Site Audit Thursday, October 20th Room Panamericano Norte 7:00 am - 04:00 pm Registrations 08:00 am - 08:30 am Welcome and Introduction to the 8th LACCR 08:30 am -10:00 am Conference: Adult Mesenchymal Stem Cells are the New Medicine for Diseases 10:00 am -10:30 am Refreshment Break 10:30 am -12:30 pm Round table: Medical Devices - Clinical trials 12:30 pm - 02:00 pm Luncheon Room Panamericano Norte Room Panamericano Sur 2:00 pm - 4:00 pm Round Table: Studies with Biological Round Table: The Contribution of Latin American Data to and Biosimilars, difficulties, Marketing Applications: A Focus on Quality challenges and opportunities 4:00 pm - 4:30 pm Refreshment Break 4:30 pm - 6:30 pm Round Table: Issues in Logistics within the Region Round Table: Understanding the Rationale behind the Design of Clinical Research: What Endpoints and Surrogates Intend to Demonstrate Friday, October 21st Room Panamericano Norte 7:00 am - 04:00 pm Registrations 08:00 am - 08:30 am IFAPP Conference 08:30 am -10:00 am Round Table: Early Phase Trials 10:00 am -10:30 am Refreshment Break 10:30 am -12:30 pm Round table: Latin American Regulatory Affairs Update 12:30 pm - 01:00 pm Conference: Pediatric Drug Development: an FDA Perspective 01:00 pm - 02:00 pm Luncheon 2:00 pm - 4:00 pm Room Panamericano Norte Round Table: Sponsoring Clinical Research by Non Traditional Players Room Panamericano Sur Round Table: Clinical Safety and Pharmacovigilance 4:00 pm - 4:30 pm Refreshment Break 4:30 pm - 6:30 pm Round Table: Ethical Issues: A Permanent Dilemma Round Table: Continued Medical Education in Clinical Research. Experiences in, Brazil and the US 6:30 pm - 6:45 pm Congress Adjourned
6 6 EXTENDED PROGRAM DAY 1 WEDNESDAY, OCTOBER 19 TH 08: REGISTRATIONS 09: PRE-CONGRESS TUTORIALS Tutorial 1: Risk Project Management Course Director Douglas Call, PhD Director, Harpum America Inc Tutorial 2: Clinical Quality Assurance, the Basics Course Directors Ezequiel Klimovsky Associate Director, QUID -Quality in Drugs and Devices- LATAM Consulting SRL, Margarita Eiletz Managing Director, Ethics & Excellence SRL, Clinical Trials with medical devices Marta Kaufman ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), Clinical Trials with medical devices Silvia Bruschini ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), Experiences from FDA Inspections on Clinical Trials with Devices in the Latin American Region Matthew J. Tarosky Acting Director, Division of Biosresearch Monitoring Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA Captain, U.S. Public Health Service I have a device, and now? Jorge Odon / Javier Schvartzman Sr. Jorge Odon Inventor Dr. Javier Schvartzman, Associate Professor, Obstetrics and Gynecology. Principal investigator, Odon Device Project - CEMIC, I Have a Device, and Now? Hugo Krupitzki Specialist in Obstetrics, CEMIC, Director of Academic Affairs. Academic Unit, Research Institute IUC. CEMIC (Centro de Educación Médica e Investigaciones Clínicas) 12:30 02:00 LUNCHEON DAY 2 THURSDAY, OCTOBER 20 TH 07: REGISTRATIONS 08:00-08:30 OPENING Welcome and Introduction to DIA 2011 s Juan Carlos Groppa, MD Congress Chairperson Past-president, Argentine Society of Pharmaceutical Medicine (SAMEFA) Medical Affairs Manager, Laboratorios Bagó S.A., Sergio Guerrero, MD Chairperson, DIA Provisional Advisory Council of Latin America (pacla) President and CEO, Accelerium Research, México Dr. Alfredo Buzzi Dean, School of Medicine, University of Buenos Aires Dr. Jorge Lemus Minister of Health, Government of the City of Buenos Aires 08:30-10:00 PLENARY SESSION Conference: Adult Mesenchymal Stem Cells are the New Medicine for Diseases María Jimena Fernández Bartolomé Clinical Studies Monitor, Pharma Division, Medical Department, Productos Roche Speaker Arnold Caplan Director, Skeletal Research Center, Professor of Biology and General Medicine Sciences, Case Western Reserve University, Cleveland Ohio, USA 10:00 10:30 REFRESHMENT BREAK 10:30-12:30 PLENARY SESSION Round Table: Medical Devices Clinical Trials Marcelo Vianna de Lima Medical Director, Latin America - Medical Diagnostics, GE Healthcare, Brazil Session Co-Chairperson Hugo Cohen Sabban President, SAMEFA (Argentine Society of Pharmaceutical Medicine) CEO, CRO BIOSOLUTION, 02:00-04:00 Round Table: Studies with Biological and Biosimilars, difficulties, challenges and opportunities (Concurrent Session) Joao Massud Professor, Federal University of São Paulo, Brazil Session Co-Chairperson Daniel Mazzolenis Director, INC Research, Studies with Biosimilars in LatAm Mauricio Seigelchifer R&D Director, PharmADN, Hemophilia Clinical Trials Pablo Rendo Considerations for Hemophilia studies Pablo Rendo Medical Director,Physician Clinician, BeneFIX Clinical Lead, Pfizer Speciality Care. USA Biosimilars and New Developments in Pharmaceutical Biotechnology. Andres Bercovich Research and Development Manager, Bio Sidus S.A Round Table: The contribution of Latin America Data to Marketing Applications: a Focus on Quality (Concurrent Session) Silvia Zieher Executive Director, Latin America Operations, INC Research, Session Co- Chairperson Earl Hulihan B.Sci., M.Ed., Senior V.P. Regulatory Affairs Medidata Solutions Global Ethical and GCP Standards in Latin America: a General Overview of the Research Ethics Committees and Regulatory Framework Anna Paula Más Associate Director, Global Regulatory Development, Latin America, Global Regulatory Affairs, Brasil An Overview of FDA Inspections Experience in Latin America. FDA Interactions with Local Regulatory Agencies Lisa López Assistant Regional Director, FDA Latin America, Regional Office, San José, Costa Rica EMA Inspections Experience in Latin America and Impact of the Reflection Paper 2010 Fergus Sweeney, EMA (via teleconference) Head of Sector Compliance and Inspections EMA (European Medicines Agency), Europe
7 7 04:00 04:30 REFRESHMENT BREAK 04:30-06:30 Round Table: Issues in Logistics within the Region (Concurrent Session) Cecilia D Antuono Site Manager, Bristol Myers Squibb, Session Co-Chairperson Rosa M. Scuteri Medical Manager, Trasplante y Líneas Especiales, Pfizer, Challenges of drug transportation and storage Flavio Echemendigaray Warehouse Manager, Genzyme, Logistics Management at sites: Issues, Challenges and Regulatory Requirements Antonela Mangiaterra Associate Manager, Clinical Logistics, PAREXEL International Clinical Logistics Services Latin America, Logistic and importation issues in Peru and Colombia Marina Ordoñez Clinical Site Manager, Bristol Myers Squibb, Perú Round Table: Understanding the Rationale behind the Design of Clinical Research: What Endpoints and Surrogates Intend to Demonstrate (Concurrent Session) Gustavo Fischbein Medical Director, Osmotica Pharmaceutical Session Co-Chairperson Marlene Llópiz Avilés President, AMEIFAC (Asociación de Médicos Especialistas en la Industria Farmacéutica, A.C.), Mexico Objectives in Cardiovascular Research Daniel R. Nul Cardiologist, Medical Director, Clínica Constituyentes, Objectives in Oncology Research Andrés Schmilovich Clinical Oncologyst, Objectives in CNS Research Gonzalo Gómez Arévalo Head of Movement Disorders Unit, Neurosciences Institute, Fundación Favaloro, DAY 3 FRIDAY, OCTOBER 21 ST 07: REGISTRATIONS 08:00 08:30 IFAPP CONFERENCE Luis Collia Medical Director, Laboratorios Craveri, Speaker Norbert Clemens Head Clinical Development, CRS Clinical Research Services Mannheim GmbH, Germany 08:30-10:00 PLENARY SESSION Conference: Early Phase Trials Leylen Colmegna CEO, LAT Research, Session Co-Chairperson Pierre Geoffroy, PhD VP Early Phases, INC Research Today s Experience in early Phase Trials David Boulton Clinical Pharmacology Director of CV Metabolism, BMS Clinical Sites and Investigators for Early Phase trials in Humans Ethel Feleder Clinical Pharma Scientific Director, F.P. 10:00 10:30 REFRESHMENT BREAK 10:30-12:30 PLENARY SESSION Round Table: Latin American Regulatory Affairs Update Sergio Guerrero Session Co-Chairperson Daniel Vazquez Senior Director and Latin America Head, Global Regulatory Affairs, Quintiles S.A., Update on Current Clinical Research Regulations Status in Different Latin American Countries Flavia Sobral Specialist in Regulation and Sanitary Surveillance, Anvisa National Agency of Sanitary Surveillance, Brasil Helen Rosenbluth Jefa, Subdepartamento Registro, Agencia Nacional de Medicamentos, Instituto de Salud Pública de Chile Ines Bignone ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), Martha Parra Díaz Director, Committee of Molecules and Clinical Research, COFEPRIS, Mexico 12:30-01:00 PLENARY SESSION Conference: Pediatric Drug Development. An FDA Perspective Sesion Chairperson Silvia Zieher Executive Director, Latin America Operations, INC Research, Speaker Benjamín Ortiz Medical Officer, International Team Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration
8 8 01:00 02:00 LUNCHEON 02:00-04:00 Round Table: Sponsoring Clinical Research by Non Traditional Players (Concurrent Session) Mario Boskis CEO, ActivaCro, Co- Fernando Martinez Executive Director Global Operations, inventiv Clinical Solutions LLC, Madrid, Spain Public and Private Consortiums in Latin America for the Development of Innovative Products Hugo Sigman CEO, Chemo Group, Promoting independent cancer research in Latin America with a hybrid model Eduardo Cazap President, Sociedad Latinoamericana y del Caribe de Oncología Médica (SLACOM), Buenos Aires, Neglected Diseases: From Discovery to Availability to Patients. A New Paradigm in R&D Isabela Ribeiro Head of Chagas Clinical Program, Drugs for Neglected Diseases Initiative (NDDI), Sao Paulo, Brazil Round Table: Clinical Safety and Pharmacovigilance (Concurrent Session) Gerardo Méndez Ciancaglini, MD Product Information & Consumer Service Department Head, Laboratorios Bagó S.A., Session Co-Chairperson Liliana Michieletto, MD Head Drug Safety Operations, Latinamerican Region, Novartis Present Regulations and Future Perspectives of Clinical Safety in. Florencia Masciottra, MD ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), Post-approval Safety Studies in, Present Status and Perspectives Inés Bignone, MD ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), Current Standards in Safety Reporting and Topics Debated in USA George Rochester, PhD RAC Center for Drug Evaluation and Research, FDA European Reporting Requirements and New Legislation Adrián Casanello, MD Clinical Safety Officer, ROPU South America, Boehringer Ingelheim High Standards in Pharmacovigilance Services Maria Vazquez-Gragg, MD -Research Triangle Institute International, USA) 04:00 04:30 REFRESHMENT BREAK 04:30-06:30 Round Table: Ethical issues: A Permanent Dilemma (Concurrent Session) Sandra Mercurio Medical Director & Lead Nominated Signatory, AstraZeneca, Session Co-Chairperson Wanda Dobrzanski Nisiewicz Medical Director, Medical & Scientific Affairs, Respiratory and Infectious Diseases, i3 Global, Post Trial Treatment Patricia Saidón Specialist in Neurology and Independent Consultant, Transforming Interactions with HCP s Regina Kuchle Legal Affairs Director, AstraZeneca, Mexico Continued Medical Education in Clinical Research. Experiences in, Brazil and the US (Concurrent Session) Juan Carlos Groppa Past President, SAMEFA ( Society of Pharmaceutical Medicine) Medical Affairs Manager. Laboratorios Bágo S.A., Speakers Educational experience in: Héctor Arenoso Member, Research and Development Committee, Laboratorios Bagó S.A., Brazil Joao Massud Filho, MD Professor, Federal University of Sao Paulo, Brazil US perspective Stephen Sonstein, PhD Director, Clinical Research Administration, Eastern Michigan University 06:30 CONGRESS ADJOURNED Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA.
9 9 EXHIBITORS ACTIVA CRO Activa CRO is a Latin American full-service CRO, based in Buenos Aires, with operations in, Brazil, Chile, Mexico, Peru and Uruguay that provides the biotechnology, pharmaceutical and medical device industry, with a range of services related to clinical development of health products. ACTIVA CRO was founded and is managed by senior professionals in Biotech, Pharmaceutical, Medical Device Development and Regulatory Affairs, with combined decades of experience and knowledge developing basic and clinical research programs. Since our establishment in 2003, we have been growing rapidly, demonstrating our company-wide commitment to unsurpassed quality, timely service and value pricing. In 2006, ACTIVA was granted ISO 9001: 2000 Standard Quality Certification on: Control and surveillance on clinical research trial processes for the development of drugs, biological products and medical devices. This certification was issued by Bureau Veritas Certification and accredited by UKAS (Europe), ANAB (North America) and OAA (South América. AGA CLINICAL Centro de Investigaciones - Neostart Corporation Av. Miguel H. Alcívar, Mz. 411 Villa 22, Guayaquil Ecuador / Telf: (Int l) / Telf: (593) We are a company dedicated 100% to improve the health and quality of life of the patients in the city of Guayaquil, especially directed to those who don t have the resources to bear the expenses of current medical care. We continuously maintain direct contact with the patient about the treatment received, always trying to develop the welfare of each of patient through quality studies. A.G.A. Clinical will exceed the expectations of our patients and sponsors with a careful professional attention and personalized service from our Investigators, the same that is backed up by a group of experienced coordinators and highly trained staff; making patient s safety and compliance are our top priority. That is why our motto is: Our commitment is to you and your health Dr. María Ximena Graber, CCRP ANDREANI Grupo Logístico Andreani is a leader company in logistics, with 3 business units in (Ligistics, Pharma and Mail) and 1 in Brazil (Loistics), all of them designed to deliver comprehensive logistic servies and each one specialized as per their scope, processes and stages in the delivery chain. Andreani is also proud of having incorporated Fundación Andreni, a non for profit organization aimed at developing educational and cultural activities throughout. CHILTERN Colectora Panamericana Ramal Pilar, Km 53,5. Edificio Polo Uno, Oficina 209 Pilar, Buenos Aires,. CP 1629 / / Established in 1982, Chiltern is a leading global clinical CRO with extensive experience in the management of Phase I-IV clinical trials across a broad range of therapeutic areas, functional service provision and contract staffing solutions. Chiltern has conducted trials in more than 40 countries, employs nearly 1,300 people globally and offers services in Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions. Chiltern prides itself as a development partner that offers flexibility, responsiveness and quality delivery. DIAGNOSTICO MAIPÚ Vicente López I Av. Maipú Martínez I Av. Santa Fe 1459 San Isidro I Alsina 30 / www. diagnosticomaipu.com Diagnóstico Maipú es un Centro de Diagnóstico de baja, mediana y alta complejidad que cuenta con tres sedes con 12 áreas de servicios en las que se desempeñan más de 550 personas. Brinda servicios a más de pacientes anuales, con tecnología de última generación. Ha certificado el sistema de gestión de calidad con Norma IRAM-ISO 9001:2008 y obtenido la certificación CENAS en calidad de atención médica. Cuenta con Departamentos de Investigación y de Docencia, y una Unidad de Investigación Clínica, que provee servicios de imágenes para protocolos. Es Institución afiliada a la UBA y desarrolla un amplio programa de responsabilidad social a través de la Fundación Diagnóstico Maipú.
10 10 DMV : Aizpurua 3012 (1431) CABA / Brazil: Rua Cônego Eugênio Leite 1122, cj 51 Cerqueira César, Sao Paulo SP / / DMV - A&C is the one and only translations office created to attend the needs of the pharmaceutical industry and CROs. We are pioneers in and Brazil working with highly specialized and qualified pharmaceutical and medical professionals translating with correct glossaries in the different fields that they comprehensively understand. DMV- A&C is synonymous of Good Translations Practices!!! FISHER CLINICAL SERVICES Heredia 563, Capital Federal, (C1427CNG), / +54 (11) / For over 20 years, Fisher has exclusively focused on servicing the packaging and distribution requirements of clinical trials accross the world. As clinical trials require increasingly complex supply chain report, our purpose-built integrated facilities provide the global presence, information systems, and flexibility to allow unparalleled flexibility and control of GMP activities from protocol design to the investigator site. Our project management approach delivers specialized skills in the planning stages to design efficiencies into pack configuration, multilingual labeling, and inventory control to ensure the receipt, package, storage and distribution of clinical trials materials worldwide. Quality Assurance teams support every project to ensure Standard Operating Procedures are strictly implemented and that current Good Manufacturing Practices are rigorously executed. With exposure to large multinational trials and thousands of protocols every year accross all therapeutic areas, Fisher Clinical Services has developed the industry s best practices in clinical supply and chain management. ICON Av. Fondo de la Legua 936/54, Piso 2, Edificio Lomas de San Isidro Plaza 1, Martinez, Buenos Aires, B1640EDO / ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development from compound selection to Phase I-IV clinical trials. Having opened our first Latin American office in 1988, we now have approximately 300 dedicated professionals in six countries, Brazil, Chile, Colombia, Mexico, and Peru, specializing in Clinical Operations, Regulatory, Quality Assurance, and Medical & Safety Services. Through more than 250 Latin-American-based studies in 12 years, our professionals have demonstrated that ICON s hallmarks of quality, flexibility, and service excellence are global characteristics that know no borders. We bring the same proven processes, work ethic, and expertise to bear on projects no matter where they are centered. INC RESEARCH INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women s health trials. The company s The Trusted Process methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina. LABORATORIO HIDALGO Ladislao Martínez 43, Buenos Aires, B1640EYA, ARG / / Located in Buenos Aires,, Laboratorio Hidalgo provides Clinical Laboratory Services related to the development of Clinical Trials in South America: reliable results and an effective logistics. The group is dedicated to meet the ever-changing demands of today s market. Services: Quality Assurance/ Control, Biological Specimen Collection/ Storage/ Distribution, Central Laboratory Services, Data Management, GCP Compliance, GLP Compliance, Project Management
11 11 LARA / LARA - Latin American Research Association- is an association of Latin American CROs that provides regional integrated Clinical Development Services. Our highly qualified medical experts, clinical operation and regulatory personnel have many years of an international experience in clinical research and regulatory affairs to are capable of addressing the challenges of an international integrated drug development, allowing us to provide our services with convenient cost and efficiency in clinical research. Our Services include C.T. Phases I, II, III and IV, Clinical Site Management, Project Management, Clinical Monitoring Services, Safety and Pharmacovigilance, QA/ QC Services, Organization and Consulting for Clinical Research Sites, Regulatory Affairs, Design, Execution and Analysis of Bioavailability and Bioequivalence studies, Pharmacovigilance services and innovative plans of biotechnological products. LINGUISTIC SERVICES Av. Ricardo Balbín 3034, C1430AAO CABA, / / Linguistic Services SA is an Argentine company with over 35 years experience partnering with local and foreign companies to deliver English to Spanish translations that result from an ISO 9001:2008 and EN 15038:2006 certified Integrated Translation Process - ITP. The use of state of the art computer assisted translation tools by university qualified translators whose mother tongue is Spanish and who work as full-time employees at the company s own purpose built facility enables LSSA to offer strategic alliances with major cost savings for the client, whilst ensuring quality, traceability, security, consistency and commitment. This makes LSSA unique in the industry. NUVISAN GMBH Fully integrated Contract Research Organisation with over 30 years of successful business operations. Services in Bioanalytics, Pharmaceutical Analytics, Phase I/ IIa, Formulation Development, Clinical Trial Supplies, CDM & Biometrics and Regulatory Affairs. We see ourselves as an international partner for the pharmaceutical industry including big pharma clients, generic or biotech companies. NUVISAN a leading CRO driven by Experience, Commitment and Technology under one roof. MARKEN Marken s superior global team and network of facilities bridge the distance between patients and the precious resources of life science companies. In existence since 1980, Marken prides itself on discerning and satisfying the premium logistical needs of the pharmaceutical, biotechnology and clinical research industries. Our global reach and expertise guarantees sophisticated handling of biological specimens and temperature-sensitive clinical trial supplies, all coordinated and managed locally through strategically-placed offices in 24 countries worldwide. Our extensive depot network supports cold storage and distribution of life science assets such as critical medications and diagnostic equipment. OCASA With more than 25 years of experience developing Logistics Solutions worldwide, OCASA s Bio-Pharmaceutical logistic service offers highest quality tailor made solutions for the Pharma Industry including export, import, distribution, fulfillment, and temperature controlled warehousing for: diagnostic specimens, medication/vaccines, experimental drugs, controlled substances, dangerous goods, and medical supplies. ORACLE 500 Oracle Parkway, Redwood Shores, CA 94065, U.S.A. / Oracle is a leading strategic software solutions provider to the health sciences industry, helping pharmaceutical, biotechnology, medical device, and healthcare organizations become the most successful in the world by offering the most innovative products and s! ervices that deliver the most compelling customer and shareholder value. Oracle s comprehensive industry solutions include clinical trial management and analysis, electronic data capture, adverse event reporting and pharmacovigilance, and healthcare interoperability. Oracle partners with health sciences industry leaders including 20 of the top 20 life sciences companies and 14 of the top 14 Fortune Global 500 healthcare organizations to prevent and cure disease, enhance quality of life, and accelerate insights for better health.
12 12 PAREXEL Av. Del Libertador nd floor, Olivos.Buenos Aires,. (B1636DSR) / PAREXEL knows scientific drug development from end-toend of the product development cycle: clinical development, integrated technologies, regulatory affairs, market access, and commercialization services. We complement your capabilities with our global reach, strategic insight, deep scientific knowledge, and tactical expertise providing you support and guidance to secure strategic advantage. With 30 years of experience and over 10,000 professionals in more than 50 countries, we provide the precise fit of expertise when, where and how you need it. PRA A leading CRO, PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, ensuring that sponsors achieve their long-term goals. We serve sponsors across all phases of pharmaceutical and biotech drug development; amassing expertise that enables us to work on a variety of compounds, ranging from niche treatments to blockbuster drugs. Our increasingly forwardthinking approach to transforming the clinical trial landscape continues to make a difference to healthcare patients around the world. PHARMANET/I3 PharmaNet/i3, the inventiv Health clinical segment, is recognized as a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, including therapeutically-specialized capabilities for Phase I-IV clinical development, bioanalytical services, and staffing from a single clinical professional to an entire functional team. For intelligent solutions needed to accelerate high quality drug development programs of all sizes around the world, PharmaNet/i3 works for you. PPD Maipú 1300, piso 15 - C1006ACT CABA, / / PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in, Brazil, Chile, Colombia, Mexico and Peru, operations in Guatemala and Panama and close to 700 professionals in Latin America (11,000 worldwide), PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. PRUDENCIA SEGUROS Lavalle 579 8º piso Buenos Aires / / Prudencia Seguros es an Insurance Company specialized in Medical Mala Praxis and Clinical Research. Founded in 1925, since 2001 the company has specialized in insurance for health care professionals and institutions. Currently, over 500 medical organizations and over 15,000 physicians participate in our programs for risk administration. Since 2010, Prudencia Seguros has developed specific insurance coverage for Clinical Research. Our policies fuilfill the Argentine Regulatory Agency requirements, extending coverage to study protocols, investigators, sites, CRO and the pharmaceutical industry. PSI CRO SRL On-Time Project Delivery Worldwide Av. Cabildo 86 3rd Floor, Buenos Aires, C1426AAN, / PSI is a leading full-service CRO operating in 35+ countries with 1,200+ employees, worldwide. PSI s key strength is predictable enrollment across multiple continents and therapeutic areas of various size and complexity. PSI is known in the industry as a CRO focused on ontime project delivery. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI s high repeat business rate is the best testament to our proactive and determined project management methodology. Incorporating PSI s philosophy of on-time results into our daily activities, we lead the industry with high quality data that is delivered when promised.
13 13 QUINTILES Quintiles is the only fully integrated biopharmaceutical services provider offering clinical, commercial consulting and capital solutions worldwide. We help customers manage change, navigate risk and seize opportunities in the new health landscape. Quintiles 24,000 talented, engaged employees in nearly 60 countries deliver on promises to customers every day, working with an unwavering commitment to patients, safety and ethics. As a pioneer in biopharmaceutical services, Quintiles has helped develop or commercialize all of the top 30 bestselling drugs. Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the biopharma industry. TRANSPERFECT / TransPerfect leads the way in life sciences translation services and solutions. Our next-generation approach centers around innovation, combining cutting-edge workflow technologies with the industry s only quality management system fully certified to EN 15038:2006 and ISO 9001:2008. When it comes to clinical development, we speak your language. Furthermore, in order to better serve the growing life sciences industry in Latin America, TransPerfect maintains local offices in Bogotá, Mexico City and Sao Paulo. Maria Fernanda Gil Commercial Director, Andean Region RPS RPS, The Next Generation CRO, provides comprehensive global Phase I-IV clinical development solutions to the Pharmaceutical, Biotechnology, Medical Device and Diagnostic industries. By combining an experienced clinical research operations infrastructure with the industry s largest resourcing engines, RPS is uniquely positioned to offer our Customers a broad spectrum of outsourcing solutions. Solutions range from globally Embedded functional and cross-functional programs to enhanced global full-service solutions. RPS operates in 45 countries. THEOREM CLINICAL RESEARCH Av. Libertador 602, Floor 7 B C1001ABT, Buenos Aires, / Theorem Clinical Research (previously Omnicare Clinical Research), is a leading global, full-service contract research organization (CRO) headquartered in King of Prussia, Pennsylvania. With office locations in 32 countries, the firm has relationships with customers all across the globe comprised of some of the world s leading pharmaceutical, biotech and medical device companies. Theorem s core CRO services are Early Phase, Phase II/III and Late Phase and the company features specialized Business Units focused on medical device, technical services and pharmaceutics. THOMSON REUTERS TVAINS INTERNATIONAL TRANSLATIONS Lavalle floor 21, Buenos Aires, (CP1051) / / 4541 Fanny Irene Tepper / TVains International Translations, leader in scientific translations for the pharmaceutical industry, CRO s and Health Care Professsionals. Our staff of physicians, pharmacists and editors, trained to guarantee the highest standards in quality and excelence. Our organization is present in and Colombia. We provide global solutions for Latin America. TVains International Translations experience and background makes it the strategic partner for the translation of documents in Regulatory Affairs, Research and Development. WORLD COURRIER World Courier is the largest and most experienced specialty courier service with a network of over 140 wholly-owned ISO 9001-certified offices operating in 50 countries. It currently operates the world s largest integrated company-owned network of GMP-compliant investigational drug storage facilities in 13 developing and strategic locations. With a fully GxPcompliant transport and supply chain system in place networkwide, World Courier meets the most demanding industry and regulatory requirements for managing time- and temperaturesensitive clinical trial materials used in global studies. World Courier investigational drug storage facilities are located in, Australia, Brazil, Chile, China, Colombia, India, México, Peru, Russia, South Africa, Singapore and Japan.
14 14 NOTES
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