Bio-Statistics

bio-statistics

We provide statistical consulting and statistical programming services to the pharmaceutical industry

GQBAY 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, GQBAY is positioned to provide strong statistical consulting and programming support utilizing sound scientific reasoning and the latest computing technology.

Staff Augmentation

GQBAY 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.

CDISC Services

CDISC Conversion, Data integration and Data Mapping services for SDTM, SDTM and ADAM dataset generating, ISS/ISE studies standardization

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, unblended statistician who provides who provides the unblinded data package for committee meetings, records meeting minutes and communicates with the sponsor representatives.

Statistical Consulting

GQBAY 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, GQBAY has experience interacting (in person, via teleconference, and via written correspondence) with the FDA, CHMP, Canadian FDA, and the KFDA.
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Facilities Management Services

Clinical and Statistical Programming: GQBAY 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: GQBAY 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.

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Our Services