Clinical Development can take years to complete, and can involve a large number of clinical trials. The preparation of submission to regulatory agencies requires aggregation of data from these trials in a consolidated and standardized form. The data the sponsor is in possession of would not be in a format that could be used for the presentation of the data to the regulatory agencies – and this requires data standardization and conversion.
Why Data Standardization?
This clinical submission process involves identifying which of the STDM datasets need to be produced, and generating the same for a submission – using the data available from multiple sources, in multiple formats. The challenge is even bigger when clinical studies are conducted over many years, and the sponsors have not followed CDISC standards while the studies were conducted, and such legacy studies need converting to SDTM to be part of a submission. This demands significant metadata logical mapping and programming, in addition to deep expertise in CDISC Standards and the understanding of clinical data.
There is significant business value that can be derived from an effective non-clinical data standards approach. SEND, or the Standard for Exchange of Nonclinical Data, is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. Standardized datasets are expected to support:
- FDA’s efforts to develop a repository for all submitted study data
- Suite of standard review tools to access, query, and view the tabulations
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released binding guidance on December 17, 2014 that sets requirements for the submission of SEND datasets.
How Can Navitas Help?
Navitas provides end to end data standards processing services that include Clinical Data Interchange Standards Consortium (CDISC)’s compliant Study data tabulation model (SDTM) and Analysis data model (ADaM) conversion activities such as annotation, mapping specification, programming, preparation of reviewers guide and define.XML. Navitas’ proprietary process and accelerators for CDISC, SDTM (Study Data Tabulation Model) conversion, increase the speed and efficiency of the drug development process for businesses in the Life Sciences vertical. They enable faster, efficient and reliable conversion of existing clinical trial data to CDISC SDTM domains that would be part of the Company’s New Drug Applications (NDA) submitted to the regulatory agencies such as the FDA and EMA, for their review and approval.
Unlike ad-hoc approaches that make the standardization a tedious and time consuming task, fraught with potential data integrity and quality risks, Navitas’ proprietary process uses standard reusable metadata repositories, software tools, and a proprietary process (modularized approach) to automate the logical mapping and to generate the SDTM data sets. Our process also embeds best practices like – checklists for logical mapping, CRF annotation, verification of SDTM datasets, automated target exception report, and guideline documents for all the activities. The resulting package includes Converted SDTM Datasets, DEFINE package, SDTM annotated CRFs and a Reviewer’s guide.
- Consulting for CDISC Standards
- SDTM Conversion
- ADaM Implementation
- Sponsor Designed Standards Implementation
- Governance Processes