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CLINICAL PROGRAMMING SERVICES |
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Quartesian has been providing exceptional programming services to its clients for 7 years. Quartesian has provided quality deliverables well within the timelines and has a record of retaining its customers.
At Quartesian we take programming seriously. We developed a PROGRAMMING PLATFORM as opposed to “one-off” or “Ad-hoc” programs.
Our statistical programmers have created a set of well thought-out and validated macros and best practices that provide framework for statistical programming which is flexible to adapt to customer’s requirements and processes. This framework combined with our Quality processes defines the “Programming Platform”.
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The Framework: |
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- Is robust such that Tables, Listings and Figures (TFL) are generated in an automated nature.
- Automates the standardized QA/ QC processes.
- Uses dataset specifications programmatically to create analysis datasets.
- Automates repetitive tasks such as TFL pagination, line breaks, title/footnotes, etc.
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The Quality Processes: |
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- Specifications define dataset structure
- Annotated table shells define table programming
- Independent Validation
- Senior reviews
- Code reviews
- Centralized status tracking
- Strict adherence to SOPs
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Our experienced team of Statistical Programmers with the help from our Biostatisticians can provide the following services for clinical studies from Phase I-IV: |
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- Analysis Datasets Specifications Development
- Creation of Derived datasets
- Creation of Tables, Listings and Figures (TFL)
- QA/QC/Validation of Datasets and TFL
- PK/PD Parameter Calculation
- Creation of ISS(SCS)/ISE(SCE) analysis databases
- Observational Study analyses
- Data Mapping
- CDISC services (SDTM, ADaM and Define.XML)
- Post Marketing Data Analyses and Reporting
- eCTD Submission Support
- Patient Profile Listings and Figures
- Patient Summaries for narratives
- Regulatory Queries Support
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