Services
Technical support for data quality oversight program (dashboards, data review listings, data visualizations)
Listings and visualizations to allow cross functional team review
Metrics to show progress of internal data quality oversight
External data transfer support (QC and reconciliation)
Loading external data transfers
Ensuring that the transfer meets specifications
Providing reconciliation or reconciliation oversight with other data sources
Data Standards administration
Ensure alignment with CDISC standards
Create governance and education around standards
DDF advisor and future state planning (link to about DDF)
Provide your company a personalized orientation to what DDF is all about
Help define the value proposition for adopting a digital data workflow
Represent your business needs in negotiations with Sponsors/CROs and Vendors w/r/t their DDF offerings.
Other DM task support as needed.
About DDF:
DDF refers to a comprehensive approach that transforms how clinical trial information is created, managed and exchanged. Traditionally, clinical trial protocols have been document-centric files. DDF shifts that paradigm by converting these protocols into structured, machine-readable formats, allowing for seamless data flow across various systems involved in a clinical trial. Imagine,
a protocol that can be integrated with your site's EHR system to calculate study budgets
a protocol that can send build specs to your EDC system
a protocol that can write your TRIAL datasets in SDTM
These and other efficiencies will be possible in this new DDF era
So, how does one get started with DDF? Google searches will lead you to websites and webinars referencing things like Github, JSON, FHIR, and Python. What??? It may feel like you’ve entered another universe. Large companies will have teams of trained experts who can shepherd their company through these changes. However, small companies typically have no such resource. That’s where I come in as your DDF consultant.