eCRF
Our AMEDON eCRF solution
Our modular AMEDON eCRF (electronic Case Report Form) solution allows you to decide: Standardized data capture and/or individualized processes. During personal consultancy, the necessary features are defined to create and configure your individualized eCRF application based on your needs.
Your study plan will be directly used for setting up the eCRF solution: secure, integrated data availability for monitoring, data management, statistics, reporting and live data views.
eCRF-Definition
M.A.R.C.O.s eCRF allows physicians, researchers and their staff to capture the data of research participants (e.g. in medical drug testing) both specifically and individually and furthermore to analyze this data in a standardized way. The objective is to streamline the multiple individual steps in a study while at the same time ensuring compliance with international regulatory and statutory requirements.
Saving time with qualified results
Our eCRF is a self-explanatory solution with integrated data and process quality checks. The easy-to-use processes combined with several automatic data entry possibilities ensures less effort for data capture and management.
Reduction of efforts for data entry
- Automatic data transfer from medical devices
- Direct data transfer from laboratories
Centralized online storage and reporting
- Risk management based on study plan & relevant event markers
- Data management and cleaning
- Risk based monitoring
- Reporting between CROs and sponsor
Supporting your processes
- Integrated plausibility checks
- Query management
- Relevant event management
- Status overview
- User guide for ToDos
- SAE reporting
- Source Data Verification
- Comprehensible roles and privileges
- Double data entry process
- Data delivery in standard formats
Additional modules
Payment management
Manage payment milestones and payment processes between investigator and payment manager.
Laboratory data management
Automatic lab data upload and integration into patients’ documentation and management of normal ranges.
Medication handling
Administer and monitor distribution and stock of medication supplies. Full integration into patient documentation.
Supply management
Order and ship individual or batch supplies between supply manager and sites. Track equipment from assignment to return.
Second opinion management
Exchange image files between sites, monitors, data management and external experts.
Device management
Manage medical devices and their data: individual owned or site devices & floating devices.
Deviation management
Tracking, classification and overview of protocol deviations.
Adverse events
Involve safety and connection to pharmacovigilance processes, automatic reporting, filing and notifications.
Randomization
Randomization with respect to cohorts and stratification, blinded and unblinded handling possible.
Interface to CTMS & data warehouse
Standardized data transfer enables data usage for management and reporting.
We would be happy to answer your questions about our services personally.