SynteractHCR CDISC Experience – Helping to Define Industry Standards

When considering what data management technology and processes are best for your drug development program, it’s important to find a CRO partner that actively participates within and across industry groups to understand current requirements, lead change, and in turn provide up-to-date guidance on the numerous options to consider. This was an objective for SynteractHCR when we first became involved with CDISC, the Clinical Data Interchange Standards Consortium, an organization at the forefront of creating streamlined industry standards for regulatory submissions.

SynteractHCR became involved with CDISC in 2004 and we have been providing CDISC services since that time, so we could play an active role in creating these standards and be able to assist clients with their regulatory submissions. We are able to provide full scope CDISC services or partial implementation based upon sponsor need, as well as CDISC recommendations and strategies for all phases of studies.

CDISC Services

  • CDASH (Clinical Data Acquisitions Standards Harmonization)
  • SDTM (Standard Data Tabulation Model for Clinical Data)
  • ADaM (Analysis Dataset Model)
  • Blankcrf.pdf
  • Metadata
  • Define.xml, Define.pdf, Define.rtf, and Define.html

Along with ongoing training and professional development, SynteractHCR data and statistical programmers stay at the forefront of new industry standards and regulatory guidelines by offering support as volunteers for CDISC. One way SynteractHCR assists CDISC is by contributing to CDASH, the Clinical Data Acquisition Standard Harmonization. The CDASH Initiative began in October, 2006 to standardize data provided to the FDA, and is purely a volunteer effort. SynteractHCR became involved in 2007, and since then, has consistently had employees voluntarily contributing to the project.

Because SynteractHCR participates in CDASH we help drive the standards. We provide input into what makes sense for data collection, resulting in cost savings and time efficiency for clients. Since we know what is happening in advance, we can provide that information to our clients so their data is collected and submitted accurately from the start

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