Quartesian has been providing exceptional programming services to its clients for almost a decade now. Quartesian has provided quality deliverables well within the timelines and has a long list of returning 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 a 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”.
The Framework:
- 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.
The Quality Processes:
- Specifications define dataset structure
- Annotated table shells define table programming
- Independent Validation
- Senior reviews
- Code reviews
- Centralized status tracking
- Strict adherence to SOPs
Quartesian provides subject randomization services using in-house developed, validated and customizable statistical randomization programs for a vast majority of study designs. The finalized randomization data can be provided in custom formats that suit clients requirements. Quartesian can provide traditional phone based randomization services, as well as a state of- the-art, secure, web-based randomization. We strictly enforce the processes as stipulated on our SOPs to ensure confidentiality and security.
Our experienced team of Statistical Programmers with the help from our Biostatisticians can provide the following services for clinical studies from Phase I-IV:
- 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
CDISC Services
Quartesian is an associate CDISC Member. Our team has extensive experience in working closely with our customers to help them get CDISC compliant. We have worked on several large scale CDISC projects, involving mapping of multiple study datasets to CDISC compliant datasets.
We have a set of in-house developed and validated macros which facilitate the conversion of any customer specific data structure to CDISC standard dataset with minimal work. This conversion process is well thought-out and automated, and it eliminates any chance of programming error.
Our services include:
- Customized CDISC solutions
- CDISC Implementation Consulting
- Mapping specification document
- Creation of CDISC SDTM compliant datasets from any customer specific data structure
- Mapping of studies from legacy to CDISC standards
- Creation of DEFINE.XML
- Creation of DEFINE.PDF
- Validation of CDISC SDTM and ADaM datasets
