Biostatistics / CDISC

How we ensure the integrity and validity of your trial data

FGK data managers are in charge of recording, compiling and accurate pre-processing of your trial data. Our highly qualified team is unafraid of new challenges and has often salvaged data that our clients thought irretrievably lost. Your data can be captured on paper and later double-entered by our personnel or electronically directly at the site. We perform data clean-up on computer and manually; there is never any doubt that our databases would not represent your case report forms. We can provide data and the corresponding documentation in CDISC SDTM and ADaM data format. We have adopted the validated, standard operating procedure driven processes, and vouch for the integrity and validity of your data.

Biostatistical support for your strategy and tactics

FGK’s analysts, programmers, and biostatisticians deliver the right tables and neat graphs, and bring extensive professional experience into your trial‘s strategy (study design) as well as tactics (e.g., sample size estimates, clinical endpoint variability modeling, and report design and structure early in the process rather than later). Of course, all the employees in this department hold respective college degrees and possess broad therapeutic expertise.

What we do in the Data Management and Biostatistics department

  • We design case report forms, databases, e-solutions
  • We determine data validation and data convention procedures, study sample size and other statistical aspects of study protocols
  • We collect and review data
  • We provide data and the corresponding documentation in CDISC SDTM and ADaM data format.
  • We analyze reported SAE and overall data according to the statistical analysis plan


CDISC Services

Our diligent team has been utilizing CDISC standards in FGK projects for over 10 years and keeps track of any new developments.
CDISC standards are learned by practical experience and our skilled Data Managers and Statisticians can offer in-depth knowledge in SDTM and ADaM data structures, implementation guides, controlled terminologies, define.xml, reviewers' guides and associated deliverables.
We help our clients to incorporate SDTM and ADaM standards to their new projects and to include their legacy data into CDISC compliant data repositories.
Contact us to learn how CDISC catalyzes information through your clinical development processes.