CDISC Standards Implementation
All clinical trial studies starting after December 17th, 2016 with the exception of certain INDs will be required to have CDISC compliant data. Any clinical trial data that is not submitted in CDISC format to the FDA can lead to a delay of submission or a “refuse to file” by the FDA.
Clindata Insight has consultants with more than 10 years of CDISC implementation experience. Our consultants have helped develop CDISC standards as team members of ADaM, SDTM and SHARE. They have also worked with FDA, CDISC and industry thought leaders to develop CDISC submission documents (e.g., reviewer guide) as PhUSE working group and committee member. Clindata Insight CDISC consultants are well known in the CDISC domain and are frequently invited to speak at various conferences because of their reputation in CDISC.
Our two levels of CDISC implementation consulting services, Clindata Analysis for Strategic CDISC Implementation (CASCI), and Data Standards Submission Readiness (DASSR), will ensure that your company is FDA compliant in submission.
CASCI will help your organization achieve regulatory compliance and operational efficiency through simple, time-efficient, cost-effective steps.
• Completing questionnaires
• Performing current state and gap analysis
• Finalizing a strategic direction
DASSR will certify that SDTM, ADaM, Metadata Repository, and eCTD QA are properly installed and utilized for submission readiness. Company-wide or team specific CDISC training is also offered as a component of this consulting process.
Level 1: Clindata Analysis for Strategic CDISC Implementation (CASCI)
Level 2: Data Standards Submission Readiness (DASSR)