Regulatory Data Standards (CDISC) and Compliance
CDISC or Clinical Data Interchange Standards Consortium is a worldwide non-profit agency. This organization is involved in formulating data standards for the pharmaceutical industry. For clinical studies there are two crucial standards, namely SDTM and ADaM. In case of non-clinical studies the standard to be followed is SEND.
At KnowTechInfo, our experts are aware and proficient with the regulatory data standards as well as compliance with government-mandated standards. The FDA has now made it obligatory to provide standard data with ANDA, BLA and NDAs.
Our world-class team has considerable experience in developing the following for our esteemed clients:
SDSP or Study Data Standardization Plans:
The SDSP helps to document as well as communicate to the FDA about the plan to describe a sponsor’s data standards in case of clinical or non-clinical studies throughout the drug development program. It acts as a crucial tool for communication between FDA and the sponsor.
SEND or Standard for Exchange of Nonclinical Data:
SEND provides a framework for the representation of animal study data in a standardized and electronic form. It facilitates in improving the efficiency and effectiveness of data review required for regulatory submissions. At KnowTechInfo, our experts are highly efficient in developing CDISC-compliant SEND datasets.
Clinical SDTM and ADaM
We also help our clients in developing CDISC-compliant SDTM and ADaM for regulatory submission. Tap here to know more.
