ez-SourceDocx
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).
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.