Leveraging Standards

Problem
During the last decade, the life sciences industry has struggled with implementing technology to optimize their businesses.  A primary reason for this is the lack of standardization in data collection, transformation, and analyses.  The Clinical Data Interchange Standards Consortium (CDISC) was formed to develop and support platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. 
Life sciences companies, as well as the FDA, are slowly beginning to adopt these standards as they gain a better understanding of the necessity to streamline the drug development and submission process.  However, after decades of legacy systems, processes and “That is the way I do it”, companies face challenges with changing people and processes.

Solution
d-Wise understands and has experienced this problem.  d-Wise combines extensive experience in clinical data collection, transformation and analysis with knowledge of CDISC and other industry standards. By using technology and standards to automate the mundane data processing and reporting tasks, your company will optimize their business model and spend more time on the real science of drug development.

How can d-Wise help you?
d-Wise helps your company by delivering:

1. a validated process for converting your buckets of legacy data to a standard model
2. a software development perspective in creating tools  to store and manage your data and metadata
3. reusable components to support the transformation and reporting of your standards
4. implementation and knowledge transfer of the SAS Clinical Data Integration Solution

By combining a unique software development background with years of experience in data standards and CDISC, d-Wise helps your company leverage standards to improve efficiency.

Standards Experience

Designed and developed a custom integration solution for a Top Ten Pharmaceutical company which included an extraction of data from the customer database conversion of data to CDISC SDTM.

d-Wise industry expert collaborated with the FDA to test the methodologies for transforming multiple clinical trial data submitted to the FDA into CDISC SDTM with the goal of creating a repository of standardized clinical trial data to improve the success rate of future studies. 

d-Wise director currently serves as the co-leader for the CDISC/FDA Integrated Safety Database Pilot, an industry-wide initiative to demonstrate that an integrated data summary created using the CDISC Standards will meet the needs and expectations of scientific reviewers.