The EMA’s requirement to publish clinical study reports means that privacy will be at risk unless those CSRs are properly anonymized
Morrisville, NC (PRWEB) March 30, 2016
d-Wise Technologies, a leading life science and healthcare technology solutions provider, announced today that they are extending their successful clinical trial patient de-identification solution, known as Blur, to anonymize clinical study reports (CSRs).
Clinical study reports are now required to be published and anonymized in accordance with the European Medicines Agency (EMA) Policy 0070, for which new implementation guidance was finalized on March 2, 2016. The details in this newly published guidance enable d-Wise to confirm alignment of Blur’s new capabilities with EMA Policy 0070, and for this important privacy solution to remain on track for availability by 4Q2016.
Clinical study reports have been part of the marketing authorization process in Europe for years, and Policy 0070 now explicitly requires these reports to be published within 60 days after a decision has been reached to approve or reject that request for authorization. Biopharmaceutical companies will need to anonymize these reports prior to publication to reduce the risk of patients being individually identified from the content in the published CSRs.
“Patient privacy is a critical aspect of transparency within the drug development and approval process”, stated John Leveille, CEO at d-Wise. “The EMA’s requirement to publish clinical study reports means that privacy will be at risk unless those CSRs are properly anonymized. d-Wise is very excited that our Blur solution for patient data anonymization enables us to rapidly extend its capabilities to anonymize CSRs.”
Biopharmaceutical companies have been redacting CSRs on a small scale for years, replacing all potentially identifying patient content with black bars or rectangles. EMA policy 0070 explicitly indicates that redaction is no longer an appropriate technique to protect patient privacy within CSRs. Instead, the CSR must be anonymized to preserve the readability of the CSR while maximizing the value of the published patient data.
The Blur anonymization solution is specifically designed to address patient privacy throughout the drug development and post-authorization process. Blur delivers high performance, application-driven, de-identification and anonymization capabilities that safeguard patient privacy while reducing the overall costs associated with protecting patient privacy. The solution has integrated workflow and controls, learned intelligence, and accommodates established as well as emerging anonymization rules. d-Wise continues to rapidly innovate and has been extending Blur’s individual patient data anonymization capabilities since its initial launch in June 2015. New extensions will provide CSR anonymization capabilities.
Blur is easily deployed through a simple browser interface, and incorporates a wide variety of clinical trials and healthcare de-identification rules that can be customized to individual projects. The availability of a point-and-click interface, instead of a programming interface, means that Blur can be used by a broad set of users providing considerably more flexibility than the current approaches being used today.
To learn more about d-Wise’s de-identification solution, please visit http://www.d-wise.com/blur-info-CSR
d-Wise Technologies, Inc. http://www.d-wise.com is a technology leader with the expertise to empower world-class life science and healthcare organizations to resolve their business optimization challenges, helping them rapidly harness and leverage data, systems and processes to gain competitive advantage.
The d-Wise Life Sciences Practice has been providing clinical advisory and modernization services to our clients for over a decade. d-Wise consultants work with Life Science clients to adopt a progressive and comprehensive approach to modernizing clinical trial solutions and processes. d-Wise helps clients identify existing business problems – systems, processes, architecture, etc. – that inhibit their ability to achieve clinical research goals. We enable this by modernizing software and solutions, business processes, and infrastructure. Solutions are tailored to meet individual client needs and deliver data integration, data warehousing and standards solutions within the highly-regulated life science industries. The company’s expertise is rooted in extensive domain knowledge of SAS software, clinical drug development and clinical data standards like CDISC. d-Wise offers end-to-end expertise and assessment services that encompass business process and change management; data and metadata-driven strategies; and vendor-agnostic infrastructure and technology assessments.
Within healthcare, d-Wise helps organizations develop an analytic vision, and integrate and streamline data operations for rapid deployment of visual intelligence solutions and advanced analytic models. d-Wise is well-known for its expertise and capability to implement advanced analytic solutions that improve operations, lower costs, improve health outcomes quality and facilitate executive decision-making. We have a broad range of experience that includes data optimization for actuarial, quality, medical management, and operational functions, as well as support for IT and data organizations looking to implement best practices.