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Good Timing – How Converging Trends Will Impact Validation for Small/Medium Pharma

  

Validation software has traditionally always been a source of great frustration for CROs and small/medium Pharma companies. Investing in and maintaining a validated statistical computing..

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Overcoming Validation Challenges for Small/Medium Companies

  

Validation. A crucial element of the pharmaceutical industry that ensures compliance, protects consumers and ultimately, saves lives. But while it’s undoubtedly a positive part of the process,..

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What is clinical trial de-identification?

  

Cathal Gallagher explains the growing importance of protecting the value of clinical trial findings - in addition to patient privacy - as clinical study reports are made public.

 

As part of a..

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Clinical Data Disclosure and Transparency Conference 2018

 

 

Why should you attend?

CBI’s 5th Annual Clinical Data Disclosure and Transparency conference will help to navigate regulatory changes at both the U.S. and international level. Develop strategies..

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d-Wise appoints VP of d-Wise Europe and establishes German office in response to rapid international growth

  • Demand for d-Wise’s clinical trials de-identification solutions soars following new regulatory demands in Europe
  • The strategic choice of Frankfurt puts d-Wise in the centre of a major pharmaceutical..

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Detailing the de-identification and data transparency boundaries of EMA Policy 70 and GDPR

As the life sciences industry prepares for compliance with EMA Policy 0070 and its requirements for the anonymization of shared clinical study reports, d-Wise has been previewing its powerful Blur..

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Exclusive first look at enhanced next-generation clinical trial de-identification platform

The latest version of the software, Blur CSR (due for release in December), offers enhanced risk management plus new controls for medical writers producing clinical study reports. (d-Wise booth at..

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Summarizing The 21st Century Cures Act

FDA gets $500M to modernize, but will the focus be real world evidence and data summaries, possibly overlooking the critical need for clinical trial data standards?

 

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d-Wise's View of Clinical Data Repositories (CDRs) - 2013

The Solution Landscape Part 1: CDR

A few weeks ago, we raised the subject of clinical data repositories (CDRs) in a LinkedIn discussion and a subsequent blog about spawning acronyms in the clinical..

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