Biostatistics and Programming
 
This service is available under either FSP (Functional full service provider model) or Piece meal service specific to biostatistics consultation is available for our clients. Services are spread across planning and designing the analysis to developing reports of the analysis of trials across all phases and across studies like Observational, exploratory, genomics, Proteomics or pharmacological molecules and registries that are compliant per ICH-E3 and CTD.
 
SAS certified / experienced programmers with system expertise in SAS 9.1.3 and SAS 9.
Design and development of effective client and protocol specific statistical analysis plan Statistical data monitoring to ensure adherence to protocol and related ethics Quality control of all the trial related documents and statistical output (double programming)
Generating Randomization lists for our trials under FSP or piecemeal service for the trials as well as emergency envelopes
Meta-analysis and clinical summary preparation
Independent data review and support services through IDMC/DSMB to our clients
Analysis and reporting of PK, PD, DNA and pharmacoeconomics
Regular planned, Ad hoc and Post-hoc analysis
Translational research data analysis and data mining
 
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