CDISC Compliant Services
Quanticate has extensive experience in helping its customers become CDISC compliant. We have worked on large and small CDISC specific projects, some involving only consultancy and others involving mapping of multiple studies to CDISC standards.
Our CDISC services include:
- Creation of customized CDISC solutions
- Building new CDISC CDASH / SDTM compliant databases
- Creation of CDISC SDTM domains from various customer defined data standards
- Mapping of studies from legacy to CDISC standards for ISS/ISE reporting and FDA submission
- Compatibility with any version of the SDTM Implementation Guide
- Converting CDISC ODM XML to SAS® datasets and vice versa
- Creation of the 'Case Report Tabulation Data Definition Specification', (aka DEFINE.XML) for submission to the FDA
- Creation of ADaM domains to support TFL output and maintain data traceability from CRF to CSR
- Statistical programming using ADaM derived datasets as inputs to the SAS® report code
I am sending this to you because I have recently worked with a member of your group and I wanted you to know how impressed I have been with their work. We recently received an extremely large data package for an ongoing clinical trial that needed summarizing and reporting out to an external Data Management Committee in a very short space of time. Under the leadership of Fiona, three members of your teams - Rhiannon, Paul, and Rupinder – managed to meet the deadlines and deliver some really high quality work. There were a number of issues with the project – the datasets were delivered later than expected with no flexibility on the delivery date, the “final” dataset kept being updated, and the team kept asking for different additional graphics as they started to see the blinded data, but everyone from Quanticate coordinated well and delivered on time!
