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Data Standardization
 TAKE Life Sciences offers leading-edge solutions and consulting to help clients streamline the clinical data lifecycle by leveraging emerging industry data standards. With strong domain and technical expertise, our Life Sciences team delivers a full spectrum of information management services and solutions. The centerpiece of our process is the CDISC (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation Model). Our teams pride themselves on teamwork, working with the sponsor toward production of regulatory-grade products throughout all stages of the clinical data lifecycle.
Our Life Sciences team provides leading-edge CDISC implementation consultation and conversion assistance under the leadership of a CDISC SDS (Submission Data Standards) team core member and SDTM author. Our teams can provide anything from hourly on-demand consulting of a few hours from time to time, to full outsourcing of the entire clinical data lifecycle, and anything in between. With our partnering approach, we initially conduct a needs assessment and map that to the client’s goals. If additional resources are needed, we provide the following expertise and production capabilities:
SDTM Mapping Solutions
Our efficient process-based methodologies and solutions help create reusable source-target mappings for the optimum generation of CDISC SDTM datasets and comprehensive submission documentation within a single process. Our senior CDISC consultants oversee all facets of implementation to ensure that the SDTM is being implemented in not only the most efficient fashion, but also the most compliant fashion. Anyone that has worked with multiple vendors and/or vendor teams claiming CDISC expertise has undoubtedly dealt with differing interpretations. From things as simple as the location of the subject randomization number to the most complex mappings—for example, where multiple SDTM general-observation-classes of data are collected in a single form/screen and need to be analyzed together—we can help. Our senior CDISC consultants ensure that there is a single interpretation of the SDTM identified, documented, managed, implemented consistently, and most importantly communicated to the client. This ensures that all SDTM databases are consistent so any/all future summary analysis, including Integrated Summaries of Efficacies (ISE) and Integrated Summaries of Safety (ISS) are streamlined. Our solutions provide for:
- Easy creation of reusable source-to-target mapping specifications for tabulation domains (annotated CRF and specification)
- Simple process to specify necessary tabulation domain derived variables
- Simple process to design and populate the Trial Design domains
- Efficient data transformation techniques for the creation of the sequence variable, supplemental qualifiers, relationships and comments
- Centralized metadata repository for end-to-end process efficiencies
CDISC Validation
Achieve SDTM and SDTM Implementation Guide compliance with the same validation rules used by the FDA:
- Verify compliance datasets with the SDTM
- Validate datasets against the SDTM Implementation Guide
- Generate Validation Report, identify structural and content issues by significance
Define.XML Generation
- Easy creation of define.xml and/or define.pdf documentation
- Standard process of producing printable define.pdf from define.xml
- Centralized metadata repository eliminates repetitive entry of metadata
Standardization Services:
- CDISC SDTM Data Standardization/Conversion
- CDISC SDTM Validation
- SDTM Mapping
- Clinical Data Warehousing
- SDTM-based data pooling to support integrated Summaries (ISS/ISE)
- Submission Documentation (define.xml, define.pdf and Annotated CRFs)
Consulting:
- CDISC Readiness/Capability Assessments
- CDISC Implementation Strategy
- SDTM Mapping Assistance
- Customized SDTM Guidance/Consulting
Our Key Differentiators:
- CDISC Registered Solutions Provider*
- CDISC SDS team core member and SDTM author
- Experienced Domain Leadership
- Partnering Approach
- Onsite and Offshore Capability
*Applied Clinical Intelligence, LLC, a subsidiary of TAKE Solutions, is a CDISC Registered Solutions Provider.
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