UNIT OF

Statistics, Data Management and Information Systems

Who we are and what we do?

We are an independent Statistics, Data Management and Information System team at IECS. Our mission is to be the bridge between data and knowledge, in permanent movement towards innovation. We provide support to clinical research studies from the IECS and external institutions.

With our extensive experience in clinical data management solutions, we combine the latest tools and technologies, robust processes and a flexible approach to ensure data quality and integrity in compliance with current standards and regulations, based on costs, timelines, study and clinical strategy.

Team

Education

New arrivals

Our scope

We have been the Data Coordinating Center for academic clinical trials from prestigious institutions such as the WHO, the Burnet Institute, Tulane University and the Infant Foundation. Over the last 10 years, we have worked in countries as diverse as Argentina, Guatemala, India, Uganda, Nigeria, Malawi, Kenya and the USA coordinating data management and statistical analysis from IECS

Areas of expertise

Systems and Tools Design

It is crucial to get it right and integrate the people involved from the early stages of the project. Our experienced team provides methodological support to develop and/or review protocols, designs the structured data management plan to ensure integrity, collaboration, adherence and transparency, and supports the successful configuration of a validated database with advanced technology to provide the perfect solution, adapted to the needs of the clinical research study, whatever its design.
Our systems, standard operating procedures (SOPs) and personnel are fully equipped to manage paper-based data capture as well as electronic data capture (EDC). This allows us to have customized, reliable and cost-effective solutions for clinical data management (CDM) operations out of the box.

Conducting and coordinating clinical studies

We offer comprehensive monitoring services for clinical trials and other clinical research designs and coordination of participating sites until their closure to support global health projects in different regions of the world. All monitoring activities are carried out in accordance with the study protocol, clinical monitoring plan, standard operating procedures (SOP), Good Clinical Practice (ICH GCP) and applicable regional regulations.
Automated reports and real-time dashboards are available to track study progress.

Information Technology

Our IT area has expert personnel who manage and maintain the servers, data collection and management systems (REDCap and Openclinica, among others) following good practices and under current regulations. They are also experts in designing web and mobile applications in the context of innovative health interventions to be evaluated with rigorous research designs.

Biostatistics

We have a team of biostatisticians who have extensive experience in established statistical techniques. We provide accurate and relevant analysis, as well as reports in Spanish and English. Together with the researchers, we design the Statistical Analysis Plan that includes the proposed data analysis, the definitions of all the populations to be analyzed, tables, and figures for the final statistical report and manuscript to be published, in Spanish and English. We design and execute interim analyzes and prepare reports for the Safety Committee if the clinical trial warrants. The analyzes are performed in R.

RESEARCH

Impact Through Research

In the last year, we have led the data management and statistical analysis of 33 clinical research studies, covering various modalities. Our work has contributed to understanding and addressing important health challenges.

Projects

Publications

Contributions to Global Health

Comprehensive participation in studies against COVID-19

We have been an integral part of fundamental studies in the fight against Covid-19. We coordinate data management and statistical analysis in crucial studies, evaluating the effectiveness of treatments and vaccines to combat the pandemic.