MED-NET has developed its own Electronic Data Capture System (e-CRF). The system is compatible with ICH-GCP and FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures requirements. System is validated according to FDA and ICH guidelines. Med-Net’s e-CRF system provides following functionality:
• Access through WEB page
• Limitation of access for authorized persons only
• Audit trial of all entries into the e-CRF
• Export of the data to formats requested by sponsor
• Ongoing control of data integrity by study specific data validation rules
• Possibility to ask questions coming from medical data review
• Ongoing control on the data flow
MED-NET e-CRF is flexible and user friendly. It can be easily adjusted to sponsor’s requirements.