Mmatiss is a Latin American Contract Research Organization (CRO). Specializing in phases I - IV, pioneer and top in the Latin American market, with more of 11 years of experience with real expertise and deep knowledge of local regulatory process, net and data base with access to clinical research professionals across all Latin American with experience in:

• Oncology
• Gastroenterology
• Central Nervous System Diseases
• Endocrine Diseases
• Infectious Diseses
• Metabolic Deseases
• Pediatric Diseases
• Gastroenterology
• Cardilogy
• Rheumatology
• Pulmonary
• Pain
• Ophtalmology
• Ortopedia

Mmatiss invests heavily in senior medical and scientific staff, staff development programs, well-designed facilities, information technology, integrated information systems, process engineering, customer account management, and quality assurance systems. Mmatiss operates with standard operating procedures systems (SOPs) and business practices with the higher international standards at every location.

Why choose a Latin American CRO?

• Our Headquarters are in Mexico which is the strategic bridge between North and South America
• The CRO is in touch with the local environment, this ensures a better knowledge of local conditions for appropriate selection of centers according to the therapeutic area, study duration, etc.
• Personal relationship and close immediate contact with expert investigators in all areas
• Experience with regulatory authorities (also FDA)
• Important cost reductions, on time delivery
• There are no cultural or language barriers (bilingual)
• High quality systems in standard operating procedures
• Assistance in the study drug import/export process
• Staff fully bilingual
• Quality assurance internal review to verify compliance with protocol and regulations
• Local independent IRB, as well as institutional IRB's
• Besides, only in the 3 major countries have a 356 million population: Argentina: 37 million Brazil: 213 million and Mexico: 106 million. This vast population in several therapeutic areas, surpasses all patient enrollment expectations for any clinical study.
• In the main cities of Latin America there are National Institutes of Health with adequate facilities, state of art in clinical research and high experience to perform clinical studies Phases II, III of complex methodology and phase IV.
• Locations Include: Argentina, Brazil, Mexico, Chile, Costa Rica, Domenic Republic, Panama, Guatemala, Peru, Ecuador, and Venezuela.

Organization:
Mmatiss has a centralize operation with headquarter in Mexico City and regional offices in Brazil, Argentina, Chile and Peru and operation in 12 countries.

Mmatiss has the best and largest staff in Latin America.

• Phase I; IIa and IIb ; III Clinical Trials
• Project Planning and Management
• Patient Recruitment including Study Feasibility
• Clinical Monitoring
• Investigator Recruitment and Site Selection
• Clinical Support Center
• Clinical Resourcing
• Clinical Pharmacology (Phase I/IIa studies)
• Bioequivalence/Bioavailability/Pharmacokinetic Studies

• Protocol design and development
• Investigator selection
• Investigator meeting
• Collection of initiation packages
• Monitoring
• Patient recruitment

• Monitor training (GCP, SOP and ICH)
• Investigator evaluation, selection, and training
• Review and collection of study documentation
• Study initiation
• Monitoring and visit reports
• Study close-out
• Pre-auditing
• Tracking tools
• Rapid data retrieval

• Design and development of CRFs
• Guidelines for data collection
• Double entry and verification
• Data management audits
• Quality assurance of final data base
• Statistical programming (SAS)
• Final and preliminary statistic análisis
• Clinical Data Management
• Biostatistics
• Scientific Programming
• Data Monitoring Committee management and support
• Traditional and electronic data capture (EDC)
• Prospective and retrospective database integration

• Investigation and selection of preclinical and clinical information
• Development of extended and reduced information for prescription
• Strategic review of the final registration dossier to be submitted to regulatory agencies
• Regulatory aspect of drug supplies management- including labeling of supplies and importation requirements
• Monitoring follow-up and control of registration procedure until authorization
• Medical and Technical advise
• Regulatory Consulting and Submission
• Validation Compliance Consulting
• Safety/Pharmacovigilance
• Medical writing

Medical Writing is part of Regulatory Documentation and is located in México.

Type of Documents Prepared:

• Protocols
• Statistical Reports
• Clinical Study Reports
• Integrated Summaries of Efficacy
• Integrated Summaries of Safety
• Publications

Contact Information

Latin American CRO Mmatiss

Mmatiss Chile
Guardia Vieja 181 - of 203
Providencia Santiago Chile
Phone: (52-55) 5135-3403
Fax: (52-55) 5135-3646
E-mail:

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