CDISC Compliance Expertise

CDISC is the most significant development for convenience in data exchange without confusion within the pharmaceutical industry and between the industry and regulatory authorities. After being recommended by FDA, this data standard has been implemented by clinical research organizations, Pharma/biotechnology companies, and other companies which use or generate clinical data. CDISC standards are employed as a service by many organizations as it brings clarity and simplicity to the clinical data which is now far more organized than before after CDISC standards implementation.

CDISC standards have a direct and strong impact on the clinical development process. CDISC standards define the data structures within the clinical database management system, case report tabulations and analysis datasets. These standards affect several operative functions where clinical data has to be handled or is handled.
Anovus Clinical Research has a very deep understanding of CDISC standards and services and believes these help in achieving the miracles in driving the Clinical Research Process.

Our Services

Legacy Study Conversion
CDISC Mapping Specification Document
SDTM, ADaM Domain Datasets Generation
Applications Development Using CDISC Standards
ISS/ISE Studies Standardization
Comprehensive Validation of SDTM & ADaM Datasets
Define XML Document
eCTD Development & Validation
CDISC Training

Site Management    Medical Writing    CDM   Statistical Analysis    Pharmacovigilance   CDISC   Regulatory Affairs

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