Services - part 1

Biostatistics

• Study design, protocol development, sample size calculation, statistical analysis planning, subject randomization, table and graph design, and report writing for study reports
• Statistical analysis of study data in support of investigator brochures, integrated summaries, post-marketing safety reports, abstracts, manuscripts, presentations and posters
• Exploratory data analysis of completed studies for publications, signal detection, planning and designing new studies

Statistical Programming

• Preparation of SDTM datasets using CDISC standards.
• Statistical analysis and programming support to data query and creation of analysis datasets, TLGs for interim analyses, IDMC and clinical study reports
• Pharmacokinetic and pharmacodynamic data analysis and modeling
• Analysis and reporting of pre-clinical data.
• Statistical programming consultation to clinical research and marketing support professionals.

CDISC Data Conversion

• Mapping and conversion of legacy data to SDTM compliant datasets
• Development of SDTM compliant pooled database for ISS/ISE analysis
• Data Warehouse design and conversion of existing datasets

On-site or Off-site Staff Placement

• On-site project support: can provide highly qualified statisticians and/or SAS programmers to work at the client's site.
• Off-site project support: To reduce sponsor's cost and maximize efficiency, can serve as an outsourcing vendor, with work done at STATCOR offices

Services - part 1   |   Services - part 2