Biostatistics

Biostatistical Services
At JCDC, we offer dedicated biostatistics services. Our statisticians hold an average industry experience

of 15+ years with expertise in R-Programming and SAS. Our bio-statistical services can be customized to

your individual needs and includes consultancy in following segments to pharmaceutical, healthcare,

clinical research industry.

We offer an end-to-end Clinical Data Management solution including:
At JCDC, we offer dedicated biostatistics services.

Our statisticians hold an average industry experience
of
15+ years with expertise in R-Programming and SAS.

Our bio-statistical services can be customized to
your individual needs and includes consultancy in following segments to pharmaceutical, healthcare, clinical research industry.

We offer an end-to-end Clinical Data Management solution including:
  • Sample size determination
  • Randomization
  • Statistical inputs for clinical trial design and clinical trial protocol
  • Development of Statistical Analysis Plan with Mock Shells
  • Statistical analysis, Programming and development of statistical report
  • Regulatory Statistical Services
  • SDTM & ADaM domains programming including listings and figures (TLFs) for Regulatory
  • Submissions
  • SDTM
  • SDTM domains generation
  • Pinnacle Validation of SDTM domains
  • SDTM Define.xml Generation
  • Validation SDTM define.xml
  • Preparing SDRG & ADRG report
  • ADaM
  • Preparing ADaM domains Spec Programming ADaM domains
  • ADaM Define.xml
  • Validation Report ADaM domains
  • Validation Report ADaM define.xml
  • ADaM Documents
  • Consulting in resolution of regulatory statistical queries