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. 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 delivering:- a validated process for converting your buckets of legacy data to a standard model
- a software development perspective in creating tools to store, manage, and govern your data standards
- a strategy for defining, adopting, and implementing data standards within your organization
- education on our perspective on where standards are today, where they are headed, and the possible impact on your organization for the US and European regions
- workshops to prepare you to implement standards from end to end in your organization
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 the HL7 and CDISC standards as well as the FDA Janus clinical data warehouse. 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.
Determined requirements and developed EHR forms servers, managers, and archive systems based on the Clinical Data Interchange Standards Consortium (CDISC) request forms data (RFD) specification. This required collaborating with healthcare and laboratory companies, public health departments, contract research organizations and pharmaceutical companies.
Evaluation of Structured Product Label (SPL) tools to allow creation of SPL documents for test submission to the FDA. This included using the tool to build several labels from content that was reverse engineered from the Daily Med web site to determine ease of use, tool
accuracy, and any errors that the FDA found in the test SPL submissions.
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 Study Data Standards Team (SDS), SDTM-BRIDG Team and the CDISC ADaM team
- Core Member of the HL7 RCRIM Working Group participating in SPL, CDISC HL7, stability and RPS message teams
- Core Member of the CDISC Life Sciences Industry Architecture Team
- Asociate Member of CDISC and member of HL7
