Our Services


CDISC Implementation:
CDISC (Clinical Data Interchange Standard Consortium) is the most widely accepted standards for exchange of clinical trial data. Under the ICH's electronic Common Technical Document (eCTD) guidance, CDISC Study Data Tabulation Model (SDTM) is the preferred standard for content format and structure of clinical data for all clinical studies. Based on proposed federal regulations, to comply with data standards guidance Pharmaceutical industry is rapidly adapting to CDISC standards.

We specialize in the following:

  • Conversion of Legacy data to CDISC
  • Creation of SDTM Annotated CRF
  • Implementation of CDASH standards
  • Implementation of SDTM and ADaM standards
  • Validation of SDTM datasets
  • Creation and validation of Define.xml
  • CDISC guidance and training
  • eCTD submissions

 

Statistical Reporting, Biostatistics and data management:
We offer a complete range of Biostatistical, Statistical programming and Data management services. Our approach focuses on fully understanding your unique set of analytical objectives, then fashioning a customized plan, tailored to helping you achieve your specific goals. Many members of our biostatistics and programming team have many years of pharma company experience in various domains ensuring a client-oriented approach to their activities. This includes a great understanding for flexibility and the need for a timely and quality product. A specially developed global statistical programming environment supports our efficient processes and, more importantly, our experienced teams.

  • Designing and development of CRFs
  • Database design and development
  • Data management
  • Statistical Analysis Plans (SAPs)
  • Development and validation of Analysis datasets and TLFs
  • Supporting DMC, DSMB, IB, CSR, ISS/ISE, health authority requests
  • Preparation of submission related documents
  • Developing global standard macros
  • Custom GUI applications