Statistical Programming

Statistical Programming

Our team of R and SaS programmers with over 15 years of industry experience, trained in in ICH/GCP and CFR PART 11 regulations and equipped with globally accepted tools and resources can optimize your clinical studies and assure fully customized regulatory submission-ready analysis datasets and Tables, Listings, and Figures (TLFs).  regulatory submissions for FDA approval.


Our Statistical Programming Team provides services in: 

  • CDISC,SEND, SDTM & ADaM standards compliant datasets development and quality control.
  • Tables, Listings, and Figures Generation.
  • Interim Analysis support
  • Bioresearch Monitoring Support

CDISC Services

Raw and analysis data from clinicals trials has to be submitted in SEND, SDTM & ADaM standards-compliant model for FDA approval. We are registered CDISC solutions providers capable of processing your raw data to fit the FDA norms.

Our CDISC Services Include:

TFL Generation

Generation and validation of Statistical data sets and TFLs are mandatory for a presentable statistical plan. Our Statisticians trained in ICH/GCP and Clinical SAS/R Programming fundamentals help you  generate TFLs for your study.

Our TFL Generation services cover:

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BIMO

 
This FDA authorized program demands a set of criteria in the pre-approval process of new medicines, devices and additives in the US market. Our team makes sure that your product/ study checks all the requirements demanded by the system by having the following listings in place: 

The listings include: