Bio-Statistics

SCIT was founded to provide statistical consulting and statistical programming services to the pharmaceutical industry

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

Staff Augmentation

SCIT 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.

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.

CDISC Services

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

Statistical Consulting

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

Facilities Management Services

Clinical and Statistical Programming: SCIT 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.<br /> Application Development/SAS Macro Development: SCIT 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.

Power / Sample size estimation

Specification writing for SDTM, ADAM, TLF

Edit check programming for Data Management team

Statistical Analysis

SAS Programs Validation and QC of Reports

Protocol and SAP Preparation

Analysis dataset generation

Creating mock shell for Tables and Listings

Statistical analysis by using validated tools like SAS®

Generating tables, Listings and Graph (Safety and Efficacy)