Overview: Data Systems for Clinical Trials

Delivering Consistent & Credible Results

EDCPRO and SAEPRO serve as the backbone of SCiAN's Web-based e-clinical and clinical trial data management solution that incorporates SCiAN's 25 years of experience in managing drug development phase I-III clinical trials. Founded on our therapeutic area expertise, the intuitive user interface helps Study Coordinators, Monitors, Project & Data Managers, Medical Monitors and Statisticians to complete their clinical trial tasks with ease, efficiency and minimum administrative overhead. 

  • Full EDC functionality
  • Randomization - all randomization algorithms and blinding methods supported
  • Study drug and clinical supply management (IWRS)
  • SAE management with SAEPRO or integration with your internal system 
  • Coding - SAE reconciliation modules
  • Central data monitoring tools
  • Document management
  • Central lab, ECG, Imaging data integation with your internal and 3rd-party systems
  • DSMBs, Interim and final analyses management module
  • CTMS modules:
    • Regulatory documents management
    • Protocol Amendments - EC/IRB approval tracking
    • Contacts management
    • Resource allocation optimization
    • Dashboard of key performance indicators: key trends, comparisons, and exceptions
    • Site payments module.

Core functionality

  • FDA 21 CFR Part 11 compliant
  • On-line help system
  • User qualification module
  • User registration and access management
  • ePRO - IWR interface
  • email notification system
  • Document Management - Medical Imaging
  • Status reporting
  • On-demand reporting / data 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.

Key features of SAEPRO

SCiAN's SAEPRO platform has been developed for IND stage (phases I - III) clinical studies to collect, review, triage, adjudicate, and report serious adverse events (SAEs) for submission to regulatory agencies, IRBs/IECs, and integration of safety information into Investigator Brochures (IBs) and IND Safety Updates.

  • Tracking regulatory submissions;
  • Status reports;
  • CIOMS-I and MedWATCH forms for reporting to agencies;
  • XML data export per E2B(M).