Clinical Data Visualization tool

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Clinical Data Visualization tools

• SUBX is an intelligent submission tool developed
  by Genpro that help sponsors to better prepare
  for their NDA/PMDA submissions. As Sponsor is
  preparing for their NDA submission tool, it is
  critical for them to verify the content and
  validity of the dataset folder per the FDA
  submission requirements. Datasets must meet the
  technical specifications per the Study Data TCG
  and eCTD validation criteria. Our submission
  validation framework will check whether the
  datasets that are provided for regulatory
  publishing is compliant to the FDA/EMEA guidance

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• SAS Data Checks
• Our framework will seamlessly integrate with SAS
  program checks which will be build against the
  FDA binding guidance document. This will be done
  using the SAS VIA REST Apis and hence will be
  able to use the SaaS architecture.
• Pinnacle 21 Validation
• Pinnacle 21 is integrated to this framework in
  order to perform SDTM/ADAM compliance validation
  of the submission datasets. All errors/warnings
  will be identified and send to the submission
  group for correction and validation.
• ECTD Publishing
• A set of standard ECTD publishing tools are also
  integrated into this framework so as to allow the
  sponsors to check for the Trial Management
  Folder. Thus the capabilities of the tool is
  extended beyond data submissions.
• M4/M5 Folder Checks
• Dynamic Rule Engines are developed so that we
  will be able to check the sanctity of the M4/M5
  folders for content and structure. These checks
  will be used by the regulatory affairs,
  regulatory publishing, biometrics and quality
  control groups of the sponsor

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Our Mission

• Our mission is to support our clients in
  achieving their goals by providing knowledge
  driven innovative solutions with highest quality
  products and services.
• WHO WE ARE
• Genpro Research is a next-generation services and
  technology partner for the pharmaceutical,
  biotechnology, and medical devices industry. Our
  tools use AI in clinical trials , Machine
  Learning, and Natural Language Processing
  algorithms to enable automation of several
  processes in a drug development pipeline.. We
  provide advanced solutions in Biostatistics
  Programming, Medical Writing, Big Data Analytics
  Service and Regulatory Submissions.

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