Mythos CDMS is a clinical data management system developed by AdWare Research, it streamlines all processes from eCRF planning, data collecting through monitoring, data cleaning till structured export for statistical analysis without requiring special IT knowledge.
The system and all operating procedures are FDA 21 CFR Part 11 and GCP compliant, validated and audited regularly by sponsors. The system goes through regular penetration testing as well.
The system was designed for users who want to process their clinical data with a reliable, secure, and high-quality system to make complete and clean data available for biostatistical evaluation as quickly as possible.
Main features
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- Security
- no need for additional software installation – only Internet connection and a browser are needed to collect clinical data in compliance with the regulations
- secure data transfer and storage – eCRF data are stored solely in the Mythos Oracle® database, on the users’ side there is not even a temporary storage. Data are transferred to the database by saving the actual eCRF page. The system uses secure SSL connection (applying data encryption) for data transfer. The Oracle database provides reliable, secure and traceable data management.
- Customizable – offers highly customizable workflows and role-based access control
- Electronic CRF appearance with automatic data monitoring – the data entry screen visualizes the CRF in a user-friendly way. By showing additional information the clarity of recorded data can be increased to speed up the database closing and evaluation process. Complex dependency management and real-time edit checks can be defined declaratively between form fields and activities (eg. visits) which needs no special IT or programming knowledge. These features provide:
- Security
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- immediate and automatic data monitoring – –during the data entry process, the system immediately indicates if the recorded data does not meet the pre-set requirements.
- explanatory notes for data entry – explanatory information can be given for every field that can help the proper data entry
- audit trail – Mythos CDMS provides complete Audit trail function and records all information about data changes: who, what, when, why has changed the data and what is the new value. The system assures that electronic records generated and maintained are “trustworthy, reliable, and generally equivalent to paper records and handwritten signatures”.
- query management
- value attached notes
- data entry progress checking
- immediate and automatic data monitoring – –during the data entry process, the system immediately indicates if the recorded data does not meet the pre-set requirements.
- Various user rights – various users can be assigned to the system with different rights.
- Source data collection – the system is suitable for collecting source data, since the entered data is entered into the eCRF at the same time and can be saved to a PDF file in real time at the site. In this way the possibility of error sources and the time spent on data entry and monitoring can be reduced
If you are interested in our system and want to know more please contact us for further information.
