eCRF
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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.

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
  

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

• 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

Additional modules

PAYMENT MANAGEMENT

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.

MEDICATION HANDLING

Administer and monitor distribution and stockof 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.

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.