CDISC

CDISC Services

Speed, Quality & Consistency, Delivered

Experts with comprehensive knowledge in the CDISC process and regulatory guidance/standards

Generation and validation of CDASH, SDTM and ADaM standard datasets or conversion of legacy data

Implementation of client specific CDISC standards in their environment

Complete generation of regulatory specifications required for submission such as Define.XML

Assurance of a high quality product every time by comprehensive QC measures on all deliverables

Also, why not automate the creation of all your trial/project displays seamlessly from the CDISC datasets we create with our Metalytics application

CDISC Process Map of Deliverables

Our approach in providing high-quality, submission ready deliverables 

Resource and plan

  • Our experts have complete CDISC domain knowledge and experience in different
    therapeutic areas
     

  • Integrated project planner with the emphasis on Risk Management, Managing timelines and maintaining Good Programming Practices (GPP) throughout, ensures the projects run smoothly untill completion
     

  • Traceability maintained in every aspect of Data Conversion
     

  • Our teams prioritise on continuous learning and training to keep up-to-date with latest standards

Assess and execute

  • Standard Operating Procedures, work instructions and checklists
     

  • Workflow oversight to generate SDTM and ADaM data packages
     

  • Ensure integrity and accuracy of all deliverables
     

  • In-built program validation and verification methods

Tools and templates

  • In-house developed pools of SAS macros and utilities are used in the conversion processes
     

  • Use of Open CDISC Validator to ensure compliance
     

  • Automated web application to generate TLFs with our own application Metalytics

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