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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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Life Science News - "Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry"

 

 

"The purpose of this guidance is to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA..

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Life Science News - EMA data transparency regulation upheld in court

 

(photo credit: outsourcing-pharma.com)

 

The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies..

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Clinical Data Disclosure and Transparency Conference 2018

January 30-31, 2018 • DoubleTree by Hilton Philadelphia Center City • Philadelphia, PA

 

Why should you attend?

CBI’s 5th Annual Clinical Data Disclosure and Transparency conference will help to..

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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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Life Science News - "Data Anonymization and Pseudonymization Under the GDPR"

 

"Companies that handle data are currently faced with constraints placed on them by data protection laws. The EU General Data Protection Regulation (GDPR) will come into effect on May of 2018 and..

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Industry News - "R vs Python: Which programming language should I learn?"

 

"Whether you're an aspiring developer or an established one looking for a change, learning a programming language is a daunting task.

With an increase in demand for developers with statistical and..

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