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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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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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Industry News - Fast-growing middle-market companies make Top 40 list

PINEHURST (OCT. 2, 2017) — Forty North Carolina companies were honored on Monday, October 2 at Pinehurst Resort for being named as the N.C. Mid-Market Fast 40 list of 2017. Accounting firm Cherry..

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Leading companies on the publication’s “Fast 50” list for 2017

Triangle Business Journal’s latest annual roundup of the 50 fastest-growing private companies in the Triangle region includes two bioscience companies and seven..

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