Key Features of Source Transcript :
Customized & reliable Data Management for integrity, accountability & speed from
database-build to database-lock by using our own software
“SOURCE TRANSCRIPT”
- US FDA 21 CFR Part 11 compliant Validated System.
- High System Scalability.
- Study Documents Repository.
- Customized Reporting & Dashboards.
- Multiple Data Extraction Formats.
- Randomization system set-up/IWR Randomization system.
- EDC/RDC or paper data-capture (e-CRF design & development).
- Database set-up (design, development and validation).
- Double Data-entry.
- Data-validation specifications.
- Medical Coding of events & medications.
- Coordinated clinical data cleaning & QC’s review.
- AE-reconciliations (in paper and EDC systems).
- Integration and transfers of external 3rd party data.
- Database Lock.
- The application development is using ASP.NET with MS.SQL data base system.
- The application is hosted on a secured windows flatform with appropriate securities for access to relevant stake holders.
- HostGator server which is located in Texas USA having auto back up.