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Other Services

Service Provider of a wide range of services which include Biostatistical Services Statistical Regulatory Support, Global Library Management Service, Project Work Scheduling, Auto Mapping Service, CDISC Consultancy and Statistical Consulting.

  • FDA preparation, consultation and meeting attendance
  • NDA/CTD regulatory filings-Integrated Efficacy/Safety Summaries
  • Electronic filings.

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The Global Library function manages the following items for re-use:
  • Set of mockups/shells for tables, listings, and figures
  • Library of statistical configurations
  • Global formats library which can be used for CDISC standards and biometrics implementation
  • Static and reserved domains and elements available as per CDISC standards
  • Library of derivation templates in different categories

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Project Work Scheduling

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EXACT features a Job Scheduler which allows for re-execution of programs and extractions at a user defined frequency

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Auto Mapping Service

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EXACT automatically maps ODM compliant clinical trial source data to CDSIC SDTM, as well as from SDTM to ADaM.

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CDISC Consultancy

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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.

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Statistical Consulting

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  • Study design, sample size estimation, randomization
  • Protocol development
  • Clinical program development.

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Statistical Analysis

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  • Statistical Analysis Plans
  • Table mock-ups
  • Programming and analysis specifications
  • SAS programming
  • Analysis data sets preparation
  • Clinical Report tables.

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  • Interim analyses and reports
  • Data Safety Monitoring Board reports
  • Final statistical reports.
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