ez-SourceDocx

Source

ez-SourceDocx from Primesoft is an entirely new and revolutionary approach to data collection at the investigative site without the need of an EMR.






The highlights of the ez-Source Docx application:
  • Easy customization of ez-SourceDocx to capture Source Data as per protocol.
  • Accurate, Legible, Contemporaneous, Original, Attributable, Complete and Consistent collection of Source Data.
  • Easy storage and retrieval of Source Documents and Source Data.
  • Exclusive control of Source Documents and Source Data by Investigator.
  • Complete Audit Trail of Source Data modifications.
  • Easy creation of controlled and accurate copies of Source Data.
  • Authorized personal only can create and modify Source Data.
  • Compliant with FDA 21 CFR Part 11 guidelines.
  • Efficient and easy transmission of Source Data to ez-EDC by the CRC/PI with a click of a button (NO DATA KEY-IN is required by site staff).
Benefits of using ez-SourceDocx
Sponsor Benefits :
  • Reduction in monitoring costs (estimated 25%)
  • Reduction in queries/discrepancies (estimated 70%)
  • Reduction in protocol violations (estimated 10%)
  • Reduction in time to data lock at end of trial (estimated 10%)
  • Consistency of source documentation across all investigative sites
Investigative Site Benefits :
  • Reduction in invalid enrollment of participants
  • More efficient collection of data allowing more participants to be processed per day
  • Less time lost to training and troubleshooting problems
  • Automatic calculations for data points such as BMI or Drug Compliance

*Contact us for further information.