At Keen Info Tek, we have great expertise of statistical programmers who have experience to analyze data of different therapeutic areas like cardiovascular, CNS, oncology, endocrinology etc., for phases I-IV clinical trials. Our missing is to provide smart solutions and carry out statistical analysis in way that will benefit our clients to get their drug approved by the FDA. We believe in quality work and offer full services ranging from maintaining the database to creating statistical reports that are submitted to FDA as a part of the final package.
Our statistical programmers at Keen Info Tek, have great knowledge and understanding of the CDISC standards and will create datasets according to CDISC guidelines. We have experts for programming SDTM’s (Standard Data Tabulation Model), ADaM’s (Analysis Datasets), tables, listings and graphs/figures (TLF’s). Our biostatistics team uses the most current version of the SDTM and ADaM implementation guide to create the datasets. We also assist in carrying out analyses for pharmacology and pharmacokinetics data. Our staff has efficiencies, experience and skills to produce accurate, high-quality and on-time deliverables.
Our services include
- Maintaining database.
- Data management.
- Creating CRF’s (Case Report Forms).
- Preparing specifications and programming of SDTM’s datasets.
- Preparing specifications and programming of ADaM’s datasets.
- Programming Define.xml reports.
- Programming Tables, Listings and graphs/figures (TLF’s).
- Analysis of pharmacology and pharmacokinetics data.