Module of the automatically generated reports
integrated with statistical software - R package.
The eCRF.bizTM system has been enriched with a new functionality - a reporting module based on the open source statistical package R. Statistical software R integration with the eCRF system allows you to enrich studies conducted in the eCRF system with automatically generated various complexity of the reports.
This module allows for:
presentation of the study progress
presentation of safety parameters, such as Adverse Events listing
generating any comparison of analyzes and statistical models in accordance to the Sponsor requirements
generating analyzes using multivariate models, logistic regression, linear or Bayesian analysis
comparison of results for the selected site with other sites participating in the study.
Type of the reports.
The report may be presented as a PDF or MS Excel file or a website. It may contain tables, charts and even descriptions updated dynamically in parallel with the study progress.
These reports influence transparency of the study progress, and through the implementation of the results comparison module between sites participating in the study, Investigators may anonymouly compare, for instance, their therapeutic solutions with those used by their colleagues from other sites.This may be especially useful in observational studies or registers. Another functionality is to generate a interim analysis template that is current at a given moment without the need to involve a statisticians. This is particularly useful tool in the early detection of abnormalities or protocol deviations, or even an unexpected increase in the frequency of adverse events associated with the IMP.
The use of the R language allows a statistical team to be involved while freeing up eCRF programmers. Additionally the generated code can be re-used to prepare a final statistical report.
Increase the maximum availability and legibility of information collected in the eCRF system.
How does digital transformation affect the efficiency of research teams?
Enhanced oversight of the study progress,
Quicker response to potential issues,
More intuitive implementation of changes resulting from protocol amendments and obtaining missing data through queries to researchers,
Automation and standardization of Data Management tasks,
Enhancing eCRF explanations and comments in response to questions from researchers.
How can monitoring costs be optimized and time spent at the center be reduced?
Thanks to the innovation of eCRF, costs and time can be significantly reduced through:
Sending notifications to Researchers from the eCRF system,
Sending notifications to Monitors,
Generating as many reports/listings as possible from the system, which will speed up the verification process, but also reporting after completed activities.
Is it possible to conclude agreements through the eCRF system?
Absolutely. There is the option to quickly and efficiently conclude an agreement via eCRF. This is undoubtedly a safe and convenient method that speeds up the process of finalizing agreements with researchers. Sending and signing documents online takes just a few minutes at most. Documents can be signed on any mobile device, such as a smartphone, tablet, or laptop.