CDISC Services

An worldwide organisation called the Clinical Data Interchange Standards Consortium (CDISC) does not aim to earn a profit from its operations. Its main objective is to establish and maintain platform-independent data standards at the industry level. These standards are frequently used in the reporting, regulatory filing, and clinical data analysis procedures. For instance, raw study data are mapped into and collected into the Study Data Tabulation Model (SDTM), which is the submission data standard, before being submitted. Since ADaM is a companion standard meant to be utilised with analysis data, it is advised that SDTM data be used as the source for these datasets. You may quickly document any data processing you undertake using the CDISC standard for data definition files, known as Define-XML. Here at Cloud Data Vision, we are specialists in mapping to CDISC Standards and provide a range of CDISC Services.

The experience that Cloud Data Visionhas in helping its clients adhere to the CDISC standard is extensive. We have participated in both significant and little projects that were unique to CDISC. While some of these initiatives only required advising, others demanded the CDISC criteria be mapped to numerous research.

Our Services Consist of :

After the creation of customised CDISC solutions

• Creating new databases that are compliant with domains built from a range of customer-defined data standards, such as CDISC CDASH/SDTM
• Studies must be mapped from legacy standards to CDISC ones in order to submit them to the FDA and comply with ISS/ISE reporting criteria.
• Compatibility with all current SDTM/ADaM standards versions and define.xml implementation manuals
• The procedure for converting datasets from SAS® to CDISC ODM XML and the other way around
• The define.xml package was made in advance of a regulatory submission to the FDA and contained reviewers’ instructions, annotated CRFs, and SAS V5 XPT files.
• ADaM domains have been developed in order to simplify TFL output and provide data traceability from CRF to CSR.
• Using datasets received from ADaM as inputs to the SAS® report code to programme statistics