Daily Archives: March 20, 2019

eCRF

eCRF. clinical data sofware. Statistics.

Discover our capabilities
Monitoring, research, analysis, statistics,
dedicated eCRF, support, security
Learn about ecrf.bizTM
Comprehensive research supportAvailable on any platform, according to the standard: FDA Title 21 CFR Part 11

The eCRF.biz™ system eliminates traditional paper documents (observation cards, reports, statements, etc.) produced and collected during project implementation. It enables remote data collection, data management, contains an analytical module that allows you to monitor progress and generate project statistics.

Thanks to the system implementation of modern analytical solutions, it effectively eliminates the risk of data shortages. It has an automatic entry control component that allows for verification of correctness already at the data input stage.
Doctor/researcher

Signature of the contract
Keeping a patient file
Issuing of medicines
Notification of adverse events
Closing of visits

Monitor/Statisticalian

Real-time preview
Creating Queries
Audit trail
Validation (SDV and others)
Export of data

Sponsor

Real-time preview
Export of data
Communication with users
Reports

Distributor

Access to the drug database
Distribution of medicines between centres and centres
Returns of medicines
Forwarding planning

Survey monitoringForeign real-time management

View patient information collected.

Statistics of collected data (summary tables, charts).

Statistics of research progress (simple, dedicated).

Possibility of printing filled in CRF forms.

Possibility to print AE/SAE forms (e.g. CIOMS).

Audit trail – tracking changes in entry values.

Data query – query mechanism for entries.

Mailing – e-mail notification of undesired events.
Second ManagementRandomization, distribution, drug delivery to patients
Randomisation

The module provides an efficient and flexible patient randomization process, allowing you to define the necessary functions needed to conduct a reliable clinical trial. FDA 21 CFR Part 11 compliant module.
Properties
Stratification of patients.
Selection of randomization methods (simple, block, biased-coin).
Blinded or unlocked options.
Configuration of registration forms.
Configuration of inclusion and exclusion criteria.
Monitoring of randomization status and tracking of patient registration status.
One-step and multi-step registration.
Drawing at the end of the last patient registration form / step.
Patient management and status monitoring
Reports, verification and data export.

See more: eCRF clinical data system