PROBLEM
During the last decade, the life sciences industry has struggled with implementing technology to optimize their businesses. A primary reason for this this challenge is the lack of standardization in data collection, transformation, and analyses. Various standards organizations such as CDISC, HL7, and ICH have been 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 understanding these standards, changing people, and adopting new processes.
SOLUTION
d-Wise understands and has experience working with clients to solve this problem. d-Wise combines extensive subject matter expertise in clinical data collection, transformation and analysis with knowledge of CDISC, HL7, 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 developing a data standards strategy by:
- Building commitment from key stakeholders and communicating the message throughout the organization
- Providing a clear understanding of where standards can improve your business process
- Developing a phased process for implementing standards providing quick wins and a comprehensive plan
for success
By combining a unique software development background with years of experience in data standards, d-Wise helps your company leverage standards to improve efficiency.
STANDARDS EXPERIENCE
Worked with three of the top ten pharmaceutical companies to develop company-wide IT strategic and tactical plans based on CDISC standards. This work included client presentations, workshop preparation, running client workshops, gathering requirements for future projects, phased implementation plans, and working to document recommended next steps.
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 individuals serve on various standards committees in the following roles:
- Co-leader for the CDISC/FDA Integrated Data Pilot
- Core member of both the CDISC ADaM and XML Technologies Teams
- Asociate Member of CDISC
Standards Conversion
