CDISC Compliance Expertise
Our CDISC services include:
- SDTM Annotated case support form
- CDASH, SDTM, and ADaM mapping and programming
- Conformance checking and Pinnacle21 validation
- eCTD submission package creation
- Define.xml generation
- Analysis Data Reviewer’s Guide (ADRG) preparation
- Study Data Reviewer’s Guide (cSDRG) preparation
- SDTM Upversioning
- Legacy data SDTM Conversion
In addition, Ephicacy has extensive expertise in standards governance and automation:
- Metadata management
- Standardization of CRF/Non-CRF, SDTM, ADaM, TLF, Codelist metadata
- Adoption of off-the-shelf/custom built MDR applications
- Metadata-driven transformation
- Automation of SDTM/ADaM Generation
- Operationalize clinical data workflows
Well-Defined, Rigorous Processes
When you send your data to prepare for regulatory submission, you need to be able to trust the quality and compliance of deliverables. Ephicacy ensures every document is correct through rigorous processes developed from our two decades of data analysis experience. Our tenured teams understand what is necessary for your data package, including a dedicated team for eSubs.
Strong CDISC Track Record
We have deep-rooted expertise in CDISC standards for clinical trials as early adopters and CDISC gold members. Our track record includes not only assisting clients with study-level data governance but also with enterprise-wide CDISC adoption, including developing automation, systems, and processes to support compliance.
Comprehensive, Tailored Support
Ephicacy has worked with companies from startups to top 10 pharma, and we understand how to work with your unique requirements. We take a collaborative approach, using our data governance and analytics expertise to help you build capabilities, support training, and develop long-term solutions for data integrity and reliability.
Ensure Compliance & Support Your Submissions
Partner with Ephicacy to take advantage of our long-standing experience and deep expertise in CDISC and other data standards.
