CDISC Services
CDISC Conversion, Data integration and Data Mapping services for SDTM, SDTM and ADAM dataset generating, ISS/ISE studies standardization
Statistical Consulting
Melius infotech 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, Melius infotech has experience interacting (in person, via teleconference, and via written correspondence) with the FDA, CHMP, Canadian FDA, and the KFDA.
Staff Augmentation
Melius infotech 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.
Facilities Management Services
Clinical and Statistical Programming: Melius infotech 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: Melius infotech 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.
