Beyond Redaction: Protect the privacy of study participants

Clinical trials produce data and reports which sponsor companies have been increasingly pressured to share with the public in the spirit of transparency. In some cases, Regulatory agencies have mandated or strongly encouraged this sharing and increasingly, researchers are demanding access to data repositories to develop new therapies. With the d-wise Clinical Transparency solutions, massive scales of clinical trial data and study reports can be shared with regulatory agencies and academia while protecting the privacy of study participants.

Anonymization of Data & CSR at Quality & Scale

With decades of  clinical data and reporting experience, d-wise in collaboration with key partners, has led the delivery of over 5,500 documents and supported development and completion of more than 30 EMA Policy 0070 and policy 0043 submissions as well as de-identifying a wide range of clinical trial data.  Our experts have leadership roles within industry organizations that influence data standards, transparency, and Policy 0070/0043 as well as consistently monitoring regulations that effect clinical submission worldwide for both pivotal and real-world studies.

d-wise Clinical Data Transparency solutions provide both a software solution and range of services to manage or outsource your complete data sharing and CSR anonymization need that fully protects patient privacy.

 

de-ID as a Service:
Outsource Anonymization of Data & CSR, Reduces Risk and Complexity

Completely outsource the processes, validation and risks involved with stricter and consistently changing regulatory policies for bringing medicine to market. New policies vary globally and are much more complex than previous requirements. Partner with d-wise to simplify the CSR and data anonymization process, while having experienced subject matter experts support your overall strategy.

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Blur Software: Anonymizes Trial Data and Documents Efficiently and Compliantly

Blur is the industry-leading software solution for anonymizing clinical trial data sets and clinical study documents on-site in partnership with multiple globally pharmaceutical companies. Blur removes many manual processes so Life Science companies spend less time and money writing code or manually reviewing thousands of CSR pages. Developed by clinical trial experts at d-wise with deep knowledge of transparency and regulations, Blur provides the unique approach of simulating all the ways data can be anonymized and allow risk to drive the anonymization. This always putting patent privacy at the forefront while illustrating the underlying data utility of each simulation allowing you to choose the highest data utility simulation within reasonable risk thresholds.