LifeTree eClinical Signs Vigiun to ClinPartners Program

LifeTree eClinical(TM), a member of the FFF Enterprises Inc. family of companies and a leading provider of clinical electronic data capture and analysis systems, today announced that the company has entered into a partnership with Vigiun Clinical and Epidemiological Research, a full-service contract research organization (CRO) based in Sao Paulo, Brazil. Vigiun will collaborate with LifeTree through its ClinPartners(TM) program to provide a suite of clinical services interfaced with the LifeTree eClinical applications.

The combined offering from Vigiun and LifeTree provides pharma and biotech sponsors many great features including: identification and selection of clinical sites; clinical protocol design; clinical trial management and monitoring; electronic data capture, analysis and reporting; data and project management; and regulatory affairs.

“Brazil is at the core of the pharmaceutical industry in Latin America,” said Eduardo Forleo, M.D., Vigiun’s medical and managing director. “The environment is ripe for Vigiun’s development through a partnership with LifeTree: We have large concentrations of potential study subjects in major cities; low production costs; numerous potential investigators, many with clinical EDC experience and plenty of GCP knowledge. With the ClinPartners program, there is no doubt we can achieve global success by utilizing the expertise of both Vigiun and LifeTree.”

“We are proud that the LifeTree eClinical suite has been approved by our latest global clinical partner,” said Gary Gabriel, Ph.D., LifeTree’s vice president of strategic marketing. “The combination of solutions and services from Vigiun and LifeTree makes it easy for sponsoring pharmaceutical companies to improve data quality and cost, while generating and accessing clinical trial data from different regions in Latin America.”

About ClinPartners

The ClinPartners program offers CROs innovative solutions for online clinical trial needs. The technology component is available in three levels, ranging from full installation of the company’s electronic suite, LifeTree ICTM(TM), on the CRO’s server to hosting of the CRO’s studies by LifeTree. The business component involves various levels of sales and marketing support that channel clinical study opportunities to LifeTree’s ClinPartner members.

About Vigiun

Vigiun is a quality Contract Research Organization located in Sao Paulo in southeast Brazil. Vigiun provides experience in several therapeutic areas including respiratory and infectious diseases, transplantation, cancer, gastroenterology and female health. They are well experienced in Phase II through IV clinical programs and in large epidemiological studies.

Vigiun was established by the same professionals in charge of the coordination of Project VigiGripe, an Influenza Surveillance Program, since the mid ’90s. This project, recognized for its importance on a national and international level, has assisted both public health authorities and the pharmaceutical industry to better understand influenza virus circulation and behavior in different regions of Brazil over several seasons.

Throughout this period, besides the epidemiological activities related to respiratory diseases, VigiGripe’s staff began to provide clinical research services to the pharmaceutical companies. Progressively, such services included other therapeutic areas. This evolution led to the company’s current name, Vigiun Clinical and Epidemiological Research, which reflects both activities and has become known for the excellence of the solutions offered to its clients.

For more information, call (55 11) 3842-2277, e-mail info@vigiun.com.br or visit www.vigiun.com.br .

About LifeTree eClinical(TM)

LifeTree eClinical, also known as LifeTree Technology LLC, is a member of the FFF Enterprises Inc. family of companies, with headquarters in Temecula. The LifeTree suite of clinical technologies and services has been used in Phase I through IV trials, patient registries and diagnostic and epidemiological studies. The LifeTree ICTM component of the LifeTree eClinical suite provides tools for clinical study design, data entry and data reporting. The suite is completely workflow driven and contains extensive clinical trial metrics and trial management tools that are built in for designated roles within the clinical trial process. SAS data on demand and a complete menu for building data reports fully empower a study’s data analyst. LifeTree ICTM’s features include comprehensive patient-safety reporting, medical coding and capabilities for handling image data. The clinical data is fully audit trailed, and it is CDISC and 21 CFR Part 11-compliant. For more information, call 800-211-2799 ext. 1356, e-mail info@lifetree-tech.com  or visit www.lifetreeclinical.com .