d-Wise developed Blur, an application-based de-identification solution, to apply the emerging rules for de-identification and integrate the execution of these rules into a comprehensive workflow-driven process that provides automated documentation, traceability and audit trails. Blur provides an enhanced platform for de-identification, a critical tool for any life sciences firm submitting data to regulatory agencies, or sharing clinical trial findings externally or internally.
The platform provides sophisticated risk management and robust data anonymization controls for biostatisticians and for medical writers charged with producing clinical study reports in compliance with EMA Policy70 guidance.
As an industry solution, Blur is updated as de-identification and redaction rules evolve and converge, and will provide a modern and superior alternative to the development and use of SAS-based de-identification scripts.
Policy 0070 from the European Medicines Agency (EMA) specifies how publicly shared CSRs should be presented – specifically in terms of patient anonymization. The EMA’s ruling on CSR treatment is just the beginning. Ultimately, the original data behind the reports will also have to be anonymized, requiring additional consideration and processes so that companies don’t get caught out – or become so lost in their de-identification efforts that they lose track of the complete, unaltered findings.
Although Europe has taken the lead on these matters, the FDA will likely follow suit, implicating U.S. based life sciences organizations to comply. With Blur, companies can be ready.
Blur understands clinical trial data structures, workflow and industry de-identification rules. Using Blur, you’ll be able to meet the regulatory and ethical challenges associated with re-purposing clinical trial data assets for secondary use, preserving data utility and documenting traceability for downstream data consumers.
Deliver high-quality de-identified clinical trial data to your internal and external collaborators at lower cost and 70% faster than any other approach available today.
"As we expand the availability and sharing of our patient-level clinical trial data to support the improvement of healthcare, we decided to streamline our processes further. d-Wise’s software solution will help us to achieve this in a way that continues to safeguard the quality of the data."
James Armbrust, AstraZeneca Head, Clinical Trial Transparency & Disclosure
Find out how Blur’s de-identification software can improve your processes, increase efficiency and reduce costs.
Download our datasheet to learn more.
No code to write. No syntax to learn.
De-identification, review and sign-off are built into the process.
Accelerate de-identification by applying templates from completed projects to new projects.
Support for PhUSE, TransCelerate and other industry rules is designed into the product.
With a broader resource pool, costs come down and efficiency goes up.
If there’s no sign-off by the reviewer, there’s no de-identified data to export.
Whether you're using CDISC or other internal standards, Blur enables you to reduce cost and time.
On-premise, in the cloud or provided as a service – d-Wise and Blur are designed to enable your success.
Blur takes the data as is, instead of requiring you to grind it into the right structure.
Menu-driven functionality limits how far you can wander from the ideal process.
Blur provides native support for reading and writing SAS data sets, SAS transport files, and more.
Detailed reports document all de-identification activities for downstream users and internal auditors.