Our regulatory data standards and integration department is a leading industry expert in the planning, preparing, and validating comprehensive data packages for regulatory submissions in the United States.

About Us

• Clinical Data Interchange Standards Consortium (CDISC) Corporate Sponsor and Registered Solutions Provider.
• Successfully made more than a dozen CDISC submissions to FDA in the last 5 years.
• Active in CDISC community with current membership on CDISC Advisory Board.
• Approved/registered technical subject matter expert on CDISC/SDTM, ODM, and Define.xml working groups.
• Active participation in the SDTM Validation, HL-7 Messages, and XML Technologies working groups.
• Worked directly with FDA in FDA JANUS Warehouse implementation working group to resolve the challenges of loading SDTM data into the JANUS repository.
• Over 50 years of combined pharmaceutical experience plus other data processing / data warehousing experience.

What We Offer

We recognize a growing need for expert data services and understand that CDISC format is desirable for internal use as well as for regulatory submissions. We apply our knowledge of how FDA reviewers use CDISC and other data to review applications and mine data, and have incorporated those concepts into all our data service offerings. We offer clients our CDISC leadership, expertise, and hands-on experience working with FDA to provide the following offerings:

• Data package submission planning
  • Guidance on the structure of databases and paper and electronic case report forms (CRF)
  • Guidance on data submission plans, including recommendations on when data should be submitted, when it can be omitted, and in what format data should be submitted (CDISC/legacy
• CDISC data conversion
  • Mapping specifications
  • Data conversion of tabulation data (SDTM) and analysis data (ADaM)
• CDISC data validation
  • Use of WebSDMTM, OpenCDISC, and our own internal programs (for checks not included in the standard software) to ensure compliance with FDA standards
  • CDISC validation activities on data packages that have been prepared by sponsors or third-party vendors
  • Interpret and resolve validation issues
• Legacy data packages
  • Preparation of data to conform to1999/2003 legacy data standards and specifications
  • Preparation of data to conform to company-specific specifications (if the data are being prepared for internal use)
• Annotated CRFs
  • Prepare annotated CRFs for both CDISC and legacy data packages
  • Perform 100% QC on all bookmarks and hyperlinks
• Define files
  • Generate data definition files for CDISC (define.xml) datasets
  • Generate data definition files for legacy datasets (define.pdf)
• Statistical support
  • Planning and authoring the statistical section of clinical protocols/CSRs
  • Estimating sample size
  • Planning and generating tables, listings, and figures
  • Interpreting and summarizing trial results