CDISC

Building on the advantages of standardization, the Clinical Data Interchange Standards Consortium (CDISC) has provided extensive guidelines for the collection, analysis and submission of clinical trial data for regulatory compliance purposes. Today CDISC standards are widely accepted by the industry and regulatory agencies, therefore necessitating the need of conversion of existing data into CDISC standards.

Vide Data Sciences is a CDISC Gold member. Our thorough understanding of CDISC standards, superior statistical programming capabilities and integrated tools and processes enable us to deliver CDISC compliant deliverables with greater efficiency.

OUR CDISC SERVICES INCLUDE

Conversion of Legacy raw data into SDTM datasets
Compliant Submisson Data Packages – SDTM annotated CRF, define.xml
Analysis ready ADaM domains, ADaM define.xml
Validation documents and OpenCDISC Report
Reviewer's Guide
SDTM/ADaM Compliant Integrated Databases

Process

We follow a three pronged approach to deliver high quality CDISC services to our clients:

Established procedures, work instructions and checklists
Defined workflow to generate SDTM and AdaM standard data packages
Validation and verification strategy to ensure integrity and accuracy of deliverables
Project management to ensure smooth project execution

People

Expert programmers with prior domain experience
Exposure of implementing CDISC standards in diverse therapeutic areas
Emphasis on continuous learning and training to remain abreast with latest standards

Tools

Use of latest technology framework like OpenCDISC Validator to ensure adherence to standards
In-house Macro library with pools of SAS macros and utilities to achieve efficiency in conversion process
Automated system to generate Define.XML