Data standards for the clinical research industry
CDISC Implementation
Veristat is an active member of the Clinical Data Interchange Standards Consortium (CDISC) and an approved Registered Solutions Provider. CDISC data standards are rapidly becoming industry standard and adopted in various phases of clinical research. With our experience we can help your company make standards implementation seamless.
CDISC Advantages
CDISC has developed a set of data standards to enhance data collection, management, analysis, and reporting efficiencies, improve safety monitoring, and streamline the review and approval process for investigational treatments. Under the ICH’s electronic Common Technical Document (eCTD) guidance, CDISC Study Data Tabulation Model (SDTM) is the preferred standard for content format and structure of clinical data for all clinical studies. Based on proposed federal regulations, the FDA will mandate that all clinical trial submissions be in electronic format and that the content comply with data standards guidance. Veristat helps our clients by not only implementing these standards on a project or program, but also by providing our clients with an understanding of the CDISC standards.
Emerging Technology
Veristat maintains current and high-level knowledge of data standards, and utilizes the latest technology platforms to assist our clients in the challenges of adhering to these new standards. Veristat has partnered with Phase Forward’s Lincoln Technologies safety division to utilize the Web Submission Data Manager (WebSDM™) application. This is the same application used by the FDA to load, review, and validate SDTM data and Define.xml files. In addition to utilizing WebSDM, we have developed a suite of additional quality assurance and control measures for data consistency and CDISC compliance. These technologies ensure our clients can submit their data to regulatory agencies with confidence.
CDISC Expertise
Veristat’s Data Submission Standards team provides expert services to our clients for successful standards adoption in every phase of development. This specialized team will ensure that your legacy study data and data from ongoing trials are migrated to submission-ready, fully CDISC-compliant SDTM data. We design Clinical Data Acquisition Standards Harmonization (CDASH) compliant CRFs for paper-based clinical trials and eCRFs for electronic data capture (EDC) clinical trials, allowing us to provide our clients with SDTM compliant data in every phase of development. Veristat leverages its years of experience in statistical analysis and strategic consulting to provide CDISC-compliant Analysis Data Model (ADaM) data for statistical analysis in support of Integrated Summaries of Safety and Efficacy.
Veristat’s CDISC Experience
To date, Veristat has converted data from numerous clinical trials and NDA programs in diverse therapeutic areas to CDISC compliant SDTM and ADaM data and designed CDASH compliant forms and databases for streamlined data management and reporting.
Veristat provides the following CDISC services:
- CDASH Compliant Case Report Forms (Paper and Electronic)
- Gap Analysis of Study Documents and Data
- CDASH and SDTM Annotated Case Report Forms
- Trial Design Compliant Data
- SDTM Compliant Data
- ADaM Compliant Data
- Integration of Controlled Terminology (CDISC and Sponsor-Defined)
- Generation of Define.xml Utilities and Define.pdf Documents
- Metadata and Data Repositories
- Utilization of WebSDM™
- Comprehensive Quality Assurance and Controlled Measures
- Strategic consultancy