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CDISC

Introduction
 
Veeda Biometrics understands the importance of implementation of CDISC standards to the clinical data for faster approval of drugs from FDA and regulatory authorities. Due to the increasing importance of standards implementation and compliance, CDISC’s programs and service offerings are under greater demand than ever before.
 
Benefits of CDISC include:
  • Standardization increases ability to reuse study elements
  • Increased efficiency and quality of communication between team members and business partners
  • Increased efficiency in deriving analysis data sets
  • Efficient tools allow time saving
  • Metadata easy to understand and reproduce
  • Reduces review time for clients as well as regulatory agencies
Our CDISC Services
 
Veeda Biometrics has good understanding of CDISC standards and helps in meeting the customer expectations and achieving speedy regulatory submissions and approvals. Hence provides a number of services on the lines of CDISC.
  • Creation of CDISC Mapping Specification Document
  • Annotation of Case Report Forms to CDISC SDTM requirements
  • Generation of SDTM Domain Datasets
  • Quality Control of SDTM Datasets
As per customer requirements, CDISC standards are implemented on a study to study basis by extensive use of validated SAS® programs.
 
Our Advantage
 
Veeda Biometrics experience with CDISC implementation helps the customer in the following ways:
  • Ensure accurate implementation of standards: Veeda Biometrics understanding of the various CDISC standards in-depth which helps in ensuring through implementation of the standards.
  • Implementation through structured approach: Veeda Biometrics has put in place various procedures to ensure quality mapping and quality control measures to ensure faster implementation of the standards.
  • Deputation of skilled professionals: Veeda Biometrics ensures hat the staffs involved in CDISC implementation has in-depth knowledge of data management, statistical analysis & programming and CDISC implementations guides.
 
To know more about Veeda services or if you have any query please click here to contact us
 
To know more how veeda’s expertise and experience for CDISC can help you, please be in touch with us using this form
 
 
 
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