Programming Services

Clinical and Statistical Programming: Protechs Info Systems 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: Protechs Info Systems 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: Protechs Info Systems has expertise and experience programming CDISC-compliant SDTM and ADaM datasets.

. Power / Sample size estimation

· Protocol and SAP Preparation

· Generating tables, Listings and Graph (Safety and Efficacy)

· Edit check programming for Data Management team

· Analysis dataset generation

· Statistical Analysis

· Specification writing for SDTM, ADAM, TLF

· Creating mock shell for Tables and Listings

· SAS Programs Validation and QC of Reports

· Statistical analysis by using validated tools like SAS®

Staff Augmentation

Protechs Info Systems 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. Statistical Consulting

Protechs Info Systems 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, Protechs Info Systems 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.

CDISC Services:

· Data integration and Data Mapping services for SDTM

· SDTM and ADAM dataset generating

· ISS/ISE studies standardization