What we do
Triangle Biostatistics was founded to provide statistical consulting and statistical programming services to the pharmaceutical industry. Triangle Biostatistics has experience working with large and small contract research organizations and large, mid-size, and small pharmaceutical companies. With extensive experience in all phases of drug development and numerous regulatory submissions across various indications, Triangle Biostatistics is positioned to provide strong statistical consulting and programming support utilizing sound scientific reasoning and the latest computing technology.
- Clinical and Statistical Programming: Triangle Biostatistics is experienced in generating analysis datasets, programming tables/figure/listing packages, in-text tables for report writing, and case report tabulations for electronic submissions. In addition, we are experienced in generating edit checks, data transfers, and data listings in support of management departments.
- Application Development/SAS Macro Development: Triangle Biostatistics can develop utilities to increase efficiencies in your day-to-day operations. We can provide a platform for managing statistical analysis requests as well as for reviewing statistical outputs.
- ADaM/SDTM/CDISC Programming: Triangle Biostatistics has expertise and experience programming CDISC-compliant SDTM and ADaM datasets.
Triangle Biostatistics has access to a broad population of independent contractors who work under the direction of client management to provide temporary support for time-sensitive projects.
Triangle Biostatistics has extensive experience in the drug development process. We can assist you in your program strategy, protocol development, CRF design, analysis plan development, and randomization schedule generation. We can also provide statistical reviews of TFL packages and clinical study reports. Finally, Triangle Biostatistics has experience interacting (in person, via teleconference, and via written correspondence) with the FDA, CHMP, Canadian FDA, and the KFDA.
Data Safety Monitoring Support
Our statisticians and programmers have fulfilled various roles in support of Data Safety Monitoring Committees (DSMC). We can assume the responsibilities of the external, unblinded statistician who provides who provides the unblinded data package for committee meetings, records meeting minutes and communicates with the sponsor representatives.