Brazil’s Butantan Institute Selects OpenClinica to Power Clinical Trials

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The Butantan Institute will use OpenClinica Enterprise Edition software for all its clinical trials. The Institute is affiliated to the Secretary of Health of the State of São Paulo and accounts for roughly 93% of serums and vaccines produced in Brazil.

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We chose OpenClinica because it offers the best solution for our clinical data capture needs. With OpenClinica’s Enterprise Edition there is no limit to the number of studies we can perform simultaneously.

OpenClinica, the world’s fastest growing clinical trial software for web-based electronic data capture (EDC) and clinical data management (CDM), is pleased to announce its contract with Brazil’s Butantan Institute.

One of the largest biomedical and clinical research centers in the world, the Butantan Institute is affiliated to the Secretary of Health of the State of São Paulo and accounts for roughly 93% of serums and vaccines produced in Brazil, including treatments for diphtheria, tetanus, pertussis, hepatitis B, rabies, influenza and H1N1.

“We chose OpenClinica because it offers the best solution for our clinical data capture needs. With OpenClinica’s Enterprise Edition there is no limit to the number of studies we can perform simultaneously. Also, with OpenClinica we get real-time access to our data to facilitate the monitoring of clinical sites, and obtain higher quality data by reducing data entry errors,” said Joao Miraglia, MD, MPH, a clinical trialist for the Butantan Institute. “We think OpenClinica will help us be more effective and more efficient in our research.”

The Institute currently has five clinical trials in its pipeline; one of which is a Phase II study. According to Miraglia, the Institute will incorporate OpenClinica into all of its clinical trials. All vaccines created by the Butantan Institute are distributed free of charge to all citizens in Brazil through the Ministry of Health.

The Butantan Institute will also be making use of OpenClinica’s internationalization capabilities and using the system in the Portuguese language.

“The Butantan Institute is an important research arm of the Brazilian Government and OpenClinica is proud to play a role in its efforts to develop accessible, life-saving vaccines,” said Ben Baumann, Co-Founder and Director of Business Development for OpenClinica.

Media Contact:
Matt Ellis
matt(at)ellisstrategies(dot)com
617-278-6560

About OpenClinica®
OpenClinica enhances the productivity of clinical trials through commercial open source software. Trusted by hundreds of biopharmaceutical companies, contract research organizations, academic, and government organizations worldwide, the OpenClinica software facilitates electronic data capture and data management, increasing the speed of collection and quality of data in clinical trials. OpenClinica supports HIPAA, 21 CFR Part 11, and other regulatory guidelines and is designed as a standards-based, extensible, and modular platform. For more information – including product downloads – visit http://www.openclinica.com or follow @OpenClinica on Twitter.

About the Butantan Institute
Butantan Institute was created by the State of São Paulo Office of Health in 1901, based on the Pasteur Institute model. In 1984, through the Brazilian Federal Government Self Sufficiency Program, it created the Center of Biotechnology aiming at the development of new technologies for the production of hyper immune sera and pediatric vaccines. The objective was to provide the Brazilian Ministry of Health with safe and efficacious immunebiologicals, presenting GMP quality, at an affordable cost. Butantan Institute produces annually approximately 100 million doses of various vaccines, in addition to 13 different hyper-immune sera.

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Matt Ellis
OpenClinica
617-278-6560
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