EDETEK provides clinical technology solutions for the biopharmaceutical, medical devices and CRO companies.
The new product forms part of the CONFORM Informatics Platform – Statistical Computing Environment (SCE) which, the company says was built to solve many challenges faced by clinical programmers and statisticians.
It features a cloud-native design, modern web-based user interface, ability to support multiple programming languages, configurable Systems Development Life Cycle (SDLC) workflow, built-in version control, reproducibility of analytical results, global and secure access, and scalable computing power for interactive and scheduled jobs for clinical studies and program-based analytics.
Real time data ingestion
“CONFORM SCE enables clinical programmers to maximize the power of the CONFORM Informatics Platform. SCE accelerates clinical study reporting, submission, analysis, and statistical modeling while having access to fully integrated CONFORM modules for real time data ingestion from more than 70 popular clinical and medical systems.
“It delivers custom configurable workflows, metadata and events management, clinical data lake and powerful designers for data validation, CDISC SDTM, ADaM mapping and transformation and TLF deliverables,” said Peter Smilansky, senior vice president of product strategy, at EDETEK.
“With the release of the CONFORM SCE and its analytical engine we have provided clinical analysts and scientists with the freedom to use their programming language of choice against the same data repository and models they already explore with our data visualization and scientific data assessment tools of CONFORM IQ,” he added.
Enhancing clinical efficiency
SCE offers a fully GxP–compliant development environment. The platform not only provides regulatory compliance functions and controls, but also manages tasks through an intuitive integrated development environment, enhancing the efficiency of clinical programmers’ daily tasks.
EDETEK says SCE integration with any CONFORM’s data pipelines and workflows enables configurations with immediate data and output refresh regardless of study size, complexity, and the number of clinical data providers. SCE can also send its output to external parties automatically upon completion of the jobs making the entire process seamless to study collaborators.
The platform has emerged as a transformative business and technical solution for increasingly complex clinical trials. It creates an end-to-end digital interoperable ecosystem to rapidly orchestrate the movement, evaluation, and submission of clinical research data through a seamless and transparent experience for all stakeholders.