DATA MANAGEMENT
Ardent Clinical Research Services provides end to end comprehensive clinical data management services to the clients from Data Management Plan to Database Lock. The team works on a robust portfolio and strives to ensure the highest quality.
Clinical Data Management Services Include :
- Project Management.
- CRF Completion Guidelines.
- Data processing through double data entry.
- Safety Data Management & Reconciliation.
- Provide Software’s to the Hospitals.
- Data Management Plan (DMP) development.
- Database Build & Design.
- Query Management.
- Data Export/Transfer.
- SAS Programming and statistical Analysis
- CRF/eCRF design and development.
- Data validation specifications.
- Medical Coding.
- Data Export/Transfer.
- Support of Phase I to post-marketing trials.
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 and 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.
Biostatistics and Programming :
Regulatory statistical consulting
Study design
Sample size estimation
Randomization scheduling
Statistical analysis plan
Statistical programming
Interim analysis support
Generation of tables, listing and figures
Provide complete support in CSR, ISS/ISE preparations