Statistical Programming services -Genpro Research

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Statistical Programming services

• We deliver consulting services in the areas of
  Biostatistics, Statistical programming, FDA
  interactions and Regulatory interactions. At
  Genpro we have an experienced and dedicated team
  of developers with detailed knowledge of all
  phases across the drug development spectrum. We
  assure customized, fully validated deliverables
  by working closely with biostatisticians to build
  and deploy your trial. Genpro provides clinical
  data mapping and data conversion services whereby
  legacy data is mapped to new data standards
  ensuring compliance with changing standards.

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Work Flow

• TFL Programming
• CDISC Services
• Phase I PK/PD
• Biomarker Analysis
• SAS Viya
• ISS / ISE Regulatory Submission Support

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• TFL Programming
• Generation and validation of Statistical data
  sets and tables/listings/figures based on the
  parameters mentioned in the Protocol, Statistical
  Analysis Plan and STL Template. Our expert
  Statistical programmers usually come with a
  background in bio statistics and have been
  trained in ICH/GCP and Clinical SAS Programming
  fundamentals. Ongoing review sessions along with
  the statisticians give them ample exposure to the
  statistical analysis plan. All the generated TFLs
  will go through a QC procedure.
• CDISC Services
• Migrate legacy database to Study Data Tabulation
  Model (SDTM) standards and Analysis dataset
  model(ADaM). Genpro has highly active, ushered
  Statistical programmers with expertise to migrate
  legacy database to Study Data Tabulation Model
  (SDTM) standards and Analysis dataset model(ADaM)
  in compliance with FDA and CDISC requirements
  with ensured quality. Our team is always updated
  with the latest versions of Guidelines published
  by CDISC.

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• Phase I PK/PD
• We engage in preparing study designs and research
  protocols for pharmacokinetic studies along with
  evaluation and generation of pharmacokinetic
  parameters. Genpro offers Phase I PK/PD analysis,
  Statistics and Clinical Reporting capabilities
• Use of standard SAS macros for Non-Compartmental
  Analysis or Compartmental Analysis
• Use of R and MS Excel for population PK/PD,
  modelling and simulation analysis
• Reporting of all analysis in accordance with
  guidelines
• Regulatory-compliant PK/PD data management
• Biomarker Analysis
• Standardized Statistical toolbox for biomarker
  analysis using trial data. These tools will be
  used to assess the quality of biomarker data,
  identify the potential error measurement of
  biomarker value, reveal the correlation among
  different biomarker variables, investigate the
  association between biomarker and clinical
  outcomes (such as response rate, survival
  duration, adverse event etc).

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• SAS Viya
• Access the capabilities of SAS via REST APIs.
  REST APIs provide a way to access the
  capabilities of SAS Viya using standard, open
  HTTP network protocols. With SAS REST APIs, you
  can create and access SAS resources using any
  client technology, such as Java, Lua, Python,
  JavaScript, C, C, Perl, Scala, or other
  programming languages. All that is necessary is a
  standard library for executing HTTP requests and
  parsing/generating JSON data.
• ISS / ISE Regulatory Submission Support
• Expert advice on combining of data for an
  Integrated Summary of Safety (ISS) or Integrated
  Summary of Efficacy (ISE), reducing approval time
  through careful up-front planning. Genpro has
  experience in developing Integrated Summaries for
  multiple clients. Our team of programmers and
  statisticians can work with the sponsor,combine
  data for an Integrated Summary of Safety (ISS) or
  Integrated Summary of Efficacy (ISE) submission.
  We can accelerate the approval times through our
  experience and planning.

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