CDISC standards implementation

With the recent communications from FDA (Providing Regulatory Submissions in Electronic Format – Guidance for Industry, December 2014) and PMDA (Technical Conformance Guide on Electronic Study Data Submissions, August 2016), there is no way around it, future submissions must conform with CDISC standards.


Read more: FDA Binding Guidance Goes into Effect


CDISC Implementation

The industry understands the need to use standards throughout the clinical data process. Legacy data conversions are very costly and error prone. There is a substantial risk of reducing the quality of clinical data and reducing the traceability between data collection and analysis. Implementing data standards in your company may seem like a daunting and complex task. Innovion can help you set-up an comprehensive framework to implement data standards in every aspect of your biometrics process.


Developing a CDISC Data Standards Library

CDASH Data collection library

  • EDC System independent metadata
  • EDC independent build instructions
  • CDASH annotated CRF library
  • Standardize data collection and data extract metadata
  • Reusable data validation rules and completion guidelines
  • SDTM-friendly data collection, ensure smooth and controlled transition to SDTM

SDTM Data Standards library

  • Storing all SDTM data models, including specific Therapeutic Area data models
  • Includes company specific SDTM domains
  • Specification instruction sheet for CROs
  • Traceable to CDASH data collection metadata
  • Stores all needed metadata for a define.xml 2.0

ADaM Data Standards library

  • Storing all standard ADaM analysis models
  • Includes company specific ADaM domains
  • Can includes standards Analysis Results Metadata (ARM)
  • Specification instruction sheet for CROs
  • Traceable to CDASH data collection metadata
  • Stores all needed metadata for a define.xml 2.0

These libraries may be automatically linked to and updated by CDISC SHARE.  Innovion has experience in implementing the CDISC SHARE API to enable automated library updates and data standards governance.


CDISC Toolset & Processes

Innovion will develop and implement all business processes that are needed to ensure submission ready deliverables such as:

  • Data Standards Governance
  • CRO oversight
  • CRO data & metadata validation
  • Metadata creation

We can help you select and implement a validated toolset and provide training for your biometrics department.


Submission Support

A good submission requires careful planning. Innovion can support you in creating submission strategies for your clinical data and analysis data, provide guidance in case of questions and help you in selecting a partner when outsourcing the conversion work.

About Innovion

Innovion aims to translate clinical data needs into sustainable solutions.

Zoetewei 118, 2580 Putte - Belgium

+32 476 545 917 |

A passion for data

We are passionate about the value of data. We love a complex challenge and deliver pragmatic, innovative and cost-effective solutions. We are convinced that efficiencies will be gained through data standardization. Expect a customer oriented service and our strong belief that success is built on partnerships.

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