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
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:
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:
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: