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What is SDTM-ETL?

A groundbreaking software solution is now available, delivering the best cost-benefit ratio for the creation of SDTM/SEND datasets and define.xml! Known as SDTM-ETL, this software is celebrated as the most economical and valuable tool in the market for generating SDTM and SEND datasets. It only necessitates that your EDC system can export clinical data in the widely accepted CDISC ODM format, which is typically supported by most EDC systems. Remarkably, SDTM-ETL operates independently of SAS®, which means you will not need to bear the expense of a SAS® license or any other statistical software. The software boasts a highly user-friendly graphical interface that enables users to create most mappings effortlessly through straightforward drag-and-drop functionality or mouse clicks. Furthermore, the define.xml files (versions 2.0 or 2.1) are produced automatically, and users can easily input details using intelligent wizards, thereby removing the hassle of tedious XML editing and complicated Excel spreadsheets. Many CROs and service providers have already adopted SDTM-ETL for their regulatory submission processes, making it a favored option in the industry. This innovative tool is not only enhancing clinical data management but is also simplifying the submission journey for numerous organizations. As a result, it stands poised to revolutionize the industry standards and practices in clinical data handling.

What is Cronos?

The in-system protocol functions as an all-encompassing training initiative, incorporating fingerprint attendance to bolster security measures. Cronos delivers workflows that are highly adaptable, specifically designed for a variety of studies, including dermal, patch, and other bioavailability-bioequivalence (BA-BE) or early-phase research endeavors. It efficiently captures, cleanses, and manages study data, regardless of whether it originates from traditional paper formats or electronic data capture (EDC) systems. Users are able to extract information into preferred datasets while adhering to industry standards such as CDISC (SDTM). The EDC tool boasts real-time activity tracking, and its Bedside Data Collection features enable faster, paperless evaluations. Additionally, Cronos encompasses a sample inventory and tracking system, providing a data repository that is compliant and ready for regulatory scrutiny. It allows for data e-printing from nearly all BA instruments and software, and includes an online review process that integrates e-stamping and e-signatures within a well-defined workflow. Users have the capability to view projects, export, and archive data seamlessly while generating high-quality statistical reports, tables, listings, and formats in both fixed and customizable layouts with impressive efficiency. This comprehensive system not only simplifies the research workflow but also significantly improves data integrity and accessibility, ensuring that researchers can focus more on their studies and less on administrative tasks. Ultimately, Cronos empowers users to manage their research data with confidence and precision, enhancing the overall quality of their findings.

Media

Media

Integrations Supported

Intertek Alchemy
Microsoft Excel

Integrations Supported

Intertek Alchemy
Microsoft Excel

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

XML4Pharma

Company Location

Austria

Company Website

www.xml4pharma.com/SDTM-ETL/

Company Facts

Organization Name

Webosphere

Date Founded

2010

Company Location

India

Company Website

cronos.ws/

Categories and Features

ETL

Data Analysis
Data Filtering
Data Quality Control
Job Scheduling
Match & Merge
Metadata Management
Non-Relational Transformations
Version Control

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

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