AMEDON's eCRFs let physicians, researchers and their staff capture the data of research subjects (e.g. in medical drug testing) to be acquired specifically and individually and to analyze them in a standardized manner. The objective is to streamline the many individual steps in a study while at the same time satisfying international regulatory and statutory requirements.

We work closely with our clients to develop individual eCRFs based on their study plan.

New - By now also including Double Data Entry module

Advantages to clinical testers, monitors, data managers, and sponsors:

Online electronic data acquisition is extremely fast - and less error-prone, thanks to integrated plausibility checks. The automated transfer of data from measuring instruments and data acquisition systems greatly reduces the effort of data acquisition, and it helps avoid data entry errors. Quantitative and qualitative statements may be made at any point of the study - even as data acquisition is still in progress.

This means that the study designers can react to current findings on the spot and - for example - modify treatment and examination parameters as the study is being conducted. The results of these modifications can itself be examined on an ad-hoc basis.

It is now possible to cut the time from entering the last patient data (Last Patient Out) to closing the database from an average of four months (!) in conventional paper-based research documentation - to as little as 48 hours.

This enormous time saving is made possible by concurrent processing of data acquisition, query management, and data consistency checks as well as centralized online data storage.

eCRF Features: An Overview

• Timely and rapid data acquisition and reporting
• Hybrid Data Capture via Digital Pen (optional)
• Integrated data check for completeness and plausibility
• Integrated query management
• Standardized documentation of adverse events
• Individually configurable roles and authorizations
• Simple and safe to use thanks to our "next steps" philosophy
• Monitoring optimized by integrated reporting
• Optimized tools for study control
• Automatic acquisition of measured data, using pulmonary function analyzers offered by our partners
• Data Capture (in parts or complete) by Double Data Entry process
• Individual integration of existing SQL data from external databases during the evaluation stage
• Data output in any desired format
• Compliance with the requirements of the FDA (21 CRF Part 11 Electronic Records and Electronic Signatures) and GAMP