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Cohort Saga Selects SMART-TRIAL for Study on how Trauma Impacts Women's Health

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News Release

For Immediate Release

Aalborg, Denmark, 19thJune 2018

Iceland's Cohort Saga Selects SMART-TRIAL Software for a Decade-Long Study on how Trauma Impacts Women's Health

SMART-TRIAL software will be used in a large nationwide research project where 110,000 Icelandic women are invited to participate

The SAGA cohort is one of the largest research projects ever undertaken to specifically addressthe potential impact of trauma or severe adversities on women's health and the potential genetic contribution to varying health trajectories after such trauma exposure. The projectCohort Saga( is undertaken by investigators at the University of Iceland in collaboration with deCODE Genetics.

During the course of their lives, most people are exposed to trauma or severe adversities. Women are frequently subjected to violence and often it happens early in their lives. The World Health Organization estimates that one in every three women are subjected to sexual or physical violence at some point. Accumulating evidence suggests that such trauma may affect both psychological and physical health. However, large research programs are still needed to significantly advance the understanding of the complex association between trauma exposure and long-term morbidities.

In all, around 110,000 Icelandic women will be invited to participate in the SAGA cohort by answering an online questionnaire on trauma history and health and by signing an informed consent for tracking of medical diagnoses and biomarkers in existing healthcare databases and biobanks during the coming decades. The project takes advantage of MEDEI's excellent software for data management and collection.

"One of our most important decisions was to select a scalable data management solution for the project. Due to the sensitive topic and the large target size, we had high demands on both security and usability. We believe we made the right decision by selecting SMART-TRIAL, because it meets our requirements for both compliance and a user-friendly interface,"  says Saga Cohort's Unnur A. Valdimarsdóttir, Principle Investigator and Project Guarantor.

"MEDEI is proud to be associated with such a large and prestigious humanitarian research project," adds Jón Ingi Bergsteinsson, MEDEI's vice-president of global business development. "Our innovative and scalable SMART-TRIAL software platform is designed for such large projects and will help Cohort Saga to simplify and better manage the on-going collection of data from this nationwide research project."


MEDEI ApS is a Danish medical software innovator that delivers industry-leading software to medical device manufacturers and clinical research.The firm's flagship product SMART-TRIAL is a unique data management platformthat helps reduce chaos and improves the collection and management of clinical data. Visit


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