GET WHAT YOU NEED
Standardized data capture and/or individualized processes.
Our AMEDON eCRF solution
Our AMEDON eCRF solution allows you to decide: Standardized data capture and/or individualized processes. With your personal contact person, the necessary features are defined to create and configure your AMEDON application based on your needs.
Your study plan will be used directly for the setup of the eCRF solution: secure, integrated data availability for Monitoring, Data Management, Statistics, Reporting and live data views.
eCRF (electronic Case Report Form): Studies on the Internet
AMEDON’s eCRF allows physicians, researchers and their staff to capture the data of research subjects (e.g. in medical drug testing) both specifically and individually and to analyze this data in a standardized way. The objective is to streamline the many individual steps in a study while at the same time satisfying 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 usable 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
- Use of digital pen feasible
Centralized online storage and reporting leads to effective…
- 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
- Userguide for ToDos
- SAE reporting
- Source Data Verification
- Comprehensible roles and privileges
- Double Data Entry process
- Data delivery in standard formats
Manage payment milestones and paymentprocesses between investigator and payment manager.
LABORATORY DATA MANAGEMENT
Automatic lab data upload and integration into patients documentation & normal ranges management.
Administer and monitor distribution and stockof medication supplies. Full integration into patient documentation.
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.
Manage medical devices and their data: individual owned or site devices & floating devices.
Tracking, classification and overview of protocol deviations.
Involve safety and connection to pharmacovigilance processes, automatic reporting, filing and notifications.
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.
Our SAE Database solution was developed according to the ICH E2B Revision 3 Standard and considering the EU case safety report business rules.
It is designed to ensure a straight forward workflow from documentation of incoming SAE/SADE reports to generated EVWEB input files during clinical trials and post market surveillance.
Our solution also fulfills all requirements to directly generate and complete CIOMS reporting PDFs.
Which topic is interesting you?
CDMS SAE Reporting Labordaten CDISC Designer Randomisierung Medical Device Payments Supply Management Imaging Medication Handling Second Opinion Review Interface E2B Data Cleaning Queries EventNotification Amendment Diary Questionnaire eCOA App Smartphone BYOD NRS/VAS/VRS Study Management Milestones Contact Management Monitoring Reporting TMF Overview Essential Documents Staff Auswertung KPI Risikomanagement RPI Controlling Data Mining Dashboard Report Standardisierung 21 CFR Part 11 Notfallmanagement Patientendaten in klinischen Studien