Managing clinical standards across clinical trials within an organization is becoming more and more challenging. Lack of governance standards and inefficient use of modern technologies become pain points of the business process for standards management.

Regulatory submission according to CDISC standards is greatly required owing to the FDA preference for such submission of clinical trial data. To ensure speed, accuracy and efficiency, doLoopTech utilizes SAS Clinical Data Integration, an innovative solution to automate the process of transforming, managing and verifying submissions compliant with CDISC data standards.

Our methodology and library of automated jobs allows the mapping of standard EDC databases and external data sources such as laboratory data into CDISC-compliant standard data sets. Additionally, we have the skills required for smooth transition of data into regulatory compliant formats.

For us, having being an integral part of the Life Sciences Industry Solution group and SAS Solution OnDemand hosting group at SAS, we can confidently say that no one knows SAS better than we do.

Our CDISC Services

Customize and Automate
CDISC solutions

Develop CDISC compliant databases

Creation of CDISC CDASH/SDTM/ADaM domain datasets

Develop SDTM/ADaM Specifications

Migration from Legacy to CDISC standards

Convert CDISC ODM XML to SAS datasets

Create Define.xml

Validation of CDISC Datasets

CRF Annotations

We will provide you with the strategy and tools to migrate from Legacy standards to CDISC.