Kinship Technologies

Services

CDISC Consultancy

Kinship has great experience in providing CDISC consultancy services to pharmaceutical and biotechnology customers and has worked on both large and small CDISC consultancy projects that involve the migration of legacy data to CDISC Standards or the integration, mapping and transformation of numerous studies to consistent CDISC data standards.

Our CDISC consultancy includes:

  • Building new CDISC SDTM; compliant databases
  • Creation of ADaM derived datasets
  • Creation of CDISC SDTM; domains from customer defined data standards
  • Creation of customized CDISC solutions
  • Mapping legacy studies from legacy to CDISC standards for ISS/ISE reporting and FDA submission
  • Converting CDISC ODM XML to SAS datasets
  • Creation of the 'Case Report Tabulation Data Definition Specification,' (define.xml) for submission to the FDA

Biostatistical Services

Kinship Biostatisticians successfully work with clients on study design, interim analyses and the final statistical analyses and reporting of regulatory submissions and approvals. The range of biostatistical services include:

  • Statistical Regulatory Support
    • FDA preparation, consultation and meeting attendance
    • NDA/CTD regulatory filings-Integrated Efficacy/Safety Summaries
    • Electronic filings
  • Statistical Consulting
    • Study design, sample size estimation, randomization
    • Protocol development
    • Clinical program development
  • Statistical Analysis
    • Statistical Analysis Plans
    • Table mock-ups
    • Programming and analysis specifications
    • SAS programming
    • Analysis data sets preparation
    • Clinical Report tables
  • Statistical Interpretation
    • Interim analyses and reports
    • Data Safety Monitoring Board reports
    • Final statistical reports

SAS Programming

Our SAS programming team has extensive experience across all clinical phases and therapeutic areas and can work seamlessly within existing client project teams or form new dedicated teams to provide quality deliverables and meet the study requirements.

Our flexible approach allows us to either use an extensive Kinship global macro library, to work within a client’s own environment, or to develop customized SAS programming solutions.

With over 15 years industry experience in providing statistical tools and consultation to trial sponsor organizations, Kinship's approach combines a deep understanding of clinical statistics with a range of programming proficiencies, including:

  • SAS programming, new macro/program creation, construction of macro libraries
  • Custom PROC development
  • SQL, S-Plus, JMP, Oracle Clinical and 3GL/4GL languages, in addition to SAS

 

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