CDISC is a global non-profit organization that has established data standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. CDISC data standards have been developed collaboratively in order to improve the quality, efficiency and cost effectiveness of clinical research processes from protocol design through analysis and reporting through regulatory submission.

Regulatory Agency Requirements
In December 2014, the FDA finalized Binding Guidance documents that make submission of electronic data mandatory, and also require the data to be in a standard format that the FDA can process, review and archive. By the end of 2016, both the FDA and PMDA will require CDISC standards for all submissions. Submissions that do not comply with the CDISC requirements after that timeframe could potentially receive a Refusal to File (RTF) from the agency.

ACI’s CDISC Expertise
ACI Clinical has been a CDISC Registered Solutions Provider for more than a decade. We have the expertise and resources needed to handle CDISC data standards conversions and integrations of all sizes, either for specific programs getting ready for submissions, or across entire enterprises.

The conversion to SDTM and the associated generation of analysis datasets is a complex process that requires not only comprehensive knowledge of Data Standards, but careful implementation. There are many challenges that sponsors typically face while dealing with submissions that involve legacy and ongoing studies, integration of multiple studies into the ISS/ISE, and establishing data point traceability back to the original data and metadata definitions. ACI Clinical’s Data Standards group is available to consult with clients on the proper way to plan and implement CDISC conversion leading up to a submission.

CDISC Standards supported by ACI Clinical
Controlled Terminology
Study/Trial Design Model
Study Data Tabulation Model (SDTM)
Clinical Data Acquisition Standards Harmonization (CDASH)
Define-XML
Analysis Data Model (ADaM)
Our team has developed a process-based conversion approach that helps us to provide high quality, on-time deliverables. The combination of our process-driven approach and our strong resource ties allow for rapid scalability to accommodate any project size. Whether you need to convert a single project’s data for regulatory submission or want to implement CDISC standards system-wide, ACI Clinical has the experience and expertise to help you.

Contact us at info@aciclinical.com or +1 (484) 429-7200 to find out how we can support you in CDISC standards planning and implementation for your clinical development programs.

CDISC Standards implementation and legacy data conversion services:

  • CDASH-compliant CRF design
  • SDTM CRF annotations
  • SDTM and ADaM mapping specifications
  • SDTM and ADaM programming and validation
  • SDTM and ADaM transport data delivery
  • Data integration and standardization for ISS/ISE
  • Define.XML creation
  • Data Safety Warehousing