Statistics, Data Management and Information Systems

We are an independent team working with the mission of bridging the gap between data and knowledge, and we are constantly striving for innovation. We provide support for clinical research studies at IECS as well as those of external institutions.

How we work

We have extensive experience in clinical data management solutions, combining the latest tools and technologies, robust processes, and a flexible approach to ensure data quality and integrity in accordance with current regulations and standards, based on cost, timelines, study size, and clinical strategy.

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 past 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

Our work areas

Systems and Tools Design

It is crucial to get it right and to 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, tailored to the needs of the clinical research study, whatever its design.
Our systems, standard operating procedures (SOPs) and staff 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.

Clinical trial management and coordinating

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 staff that manages and maintains 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 with 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, 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 it. 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, spanning a variety of 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.