EDCPRO: Clinical Trial Data Management
Software
Meeting the needs of Study Coordinators, CRAs & Projects
Managers
EDCPRO is a powerful and effective Web-based clinical
data management system that incorporates SCiAN's 15 years of EDC
knowledge and experience in managing clinical trials. Founded on
our therapeutic area expertise, the intuitive user interface helps
Study Coordinators and Monitors complete their data management
tasks with ease, efficiency and minimum administrative
overhead.
EDCPRO guides Study Coordinators and Monitors towards
consistent data collection and protocol interpretation. In
addition, the system was designed with a comprehensive suite
of data management tools to support the work of Medical Monitors,
Database Managers (tools for coding, SAE reconciliation,
preparation of database for DSMBs, interim and final analyses,
etc).
Core functionality
- FDA 21 CFR Part 11 compliant
- On-line help system
- User qualification module
- User registration and access management
- Randomization
- Study drug / clinical supply management
- Online data validation / edit checks
- SDV and associated query management
- ePRO - IWR interface
- Auto email notification system
- Document Management
- Status reporting
- On-demand reporting / data export: Excel database export
- Data import using CDISC ODM compliant transfers from 3rd
parties
- Data export / archiving using CDISC ODM compliant XML
format
- PDF archiving.
Extended functionality for high impact trials
For comprehensive support of drug development phase
clinical trials where the risk of delays and data inconsistencies
have to be minimized, the systems includes additional safeguards
and functionalities, such as:
- Proprietary "Guided Data Entry"™ system;
- Customizable workflow to incorporate the
Sponsor's/CRO's business practices and SOPs;
- Active case management;
and a comprehensive set of data management tools to support the
work of Medical Monitors, Database Managers, Statisticians and
Medical Writers; tools for:
- On-demand PDF/Excel case histories
- On-demand plots / graphs
- Coding medical history, adverse events, medications
- Reconciling SAE between the clinical and safety databases
- Preparation of database for DSMBs
- Preparation of the database for formal interim and final
analyses.