Data Standards

Decades of experience in CDISC standards implementation

We combine our decades of CDISC standards implementation expertise and regulatory experience to produce the highest quality clinical databases that allow regulatory reviewers to focus on your clinical results.

CDISC standards are now required for all clinical data submitted in support of a marketing application to the US FDA as well as other ex-US regulatory bodies.  CDISC standards include the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM).  Rho has been, and continues to be, an industry leader in formulating and adopting CDISC standards, contributing to the development of several aspects of the current standards and helping speed their arrival to the industry.

Over the past two decades, our data standards experts have helped sponsors pragmatically apply CDISC standards to their clinical data across a wide spectrum of therapeutic areas and FDA review divisions, including more than 200 clinical protocols and 40 US and ex-US marketing applications.

We combine our depth of experience in applying CDISC standards with our extensive regulatory interactions to produce high quality, highly compliant clinical databases in which you and regulatory reviewers will be confident.

Standards Application

There are many considerations around how and when to implement data standards into your clinical development program, and these considerations can seem daunting.  We can help make the standards implementation process manageable and seamless by helping to design a standards implementation plan that best suits your development plans or executing on an existing implementation plan.  Our experts will bring their breadth and depth of industry experience and involvement, as well as Rho’s industry-leading tools, to your clinical data.  We have extensive experience creating and/or applying clinical data standards in the following settings:

  • Development program Data Standardization Plan design and implementation
  • Single protocol standards implementation
  • Multiple protocol standards implementation
  • Post-hoc legacy data conversions
  • Integrated database creation (ISS/ISE/ISM)
  • Data standards Gap Analysis and assessment of an existing program

Our data standards experts provide:

  • Application of the SDTM model, IG versions 3.1.3 to 3.3
  • Application of the ADaM model, versions 1.0 to 1.2
  • Fully compliant electronic data submission packages, including:
    • xml files for SDTM and ADaM
    • .xpt files
    • SDTM and ADaM study data reviewer guides
    • annotated case report forms
    • annotated dataset and analysis programs in submission compliant format
  • Assessment of SDTM and ADaM conformance with Pinnacle 21 Enterprise, the same software used by FDA
  • Analysis Results Level Metadata (ARM)
  • Implementation of controlled terminology