samedan logo
 
 
spacer
home > ict > autumn 2017 > through the clouds
PUBLICATIONS
International Clinical Trials

Through the Clouds

The ubiquitous nature of cloud computing offers new ways
to both collect information from disparate sources and
introduce real world evidence into studies. The industry is
reaching a point in which genomic, laboratory, imaging and
wearable sensor data can be ingested seamlessly into clinical
trial data management systems. These new sources create a
much richer dataset, but what do they mean for the field of
data management?

Managing the Benefits

At its core, cloud computing enables advanced machine
learning that can replace many of the mundane and error-
prone practices of traditional data management. For instance,
the ICH recently amended its Good Clinical Practice guidelines
to encourage companies to embrace risk-based monitoring
practices. Why? Because the ICH called out the pharmaceutical
industry’s misguided focus on the “completeness and accuracy
of every piece of data at the expense of critical aspects (e.g.,
carefully managing risks to the integrity of key outcome data).”

It comes as no surprise, then, that the FDA, EMA and
other agencies represented at the ICH are following suit
and encouraging fresh approaches.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Mike Capone brings a unique blend of client-facing operational experience and strong technical knowledge to his role as Head of Operations at Medidata. In his capacity as Chief Operating Officer, Mike oversees delivery of all of the company’s products and services, including product management, software development, data science, professional services and marketing.
spacer
Mike Capone
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

AptarGroup, Inc. wins the Excellence in Pharma

AptarGroup, Inc., a leading global supplier of a broad range of innovative dispensing and sealing solutions for the beauty, personal care, home care, prescription drug, consumer health care, injectables, food and beverage markets, announces that it was awarded the inaugural Excellence in Pharma: Sustainability Initiative of the Year at CPhI Worldwide 2017. The award was presented as part of the CPhI Pharma Awards Gala, which took place Tuesday, October 24 at the Intercontinental Hotel in Frankfurt, Germany.
More info >>

White Papers

Quality of Steel

Natoli Engineering Company, Inc.

Steel quality is the summation of how well a steel meets its specified chemistry, the cleanliness of the steel or degree to which it is free of impurities or inclusion, homogeneity of the microstructure, grain/carbide size and in some instances if it meets the mechanical requirements for that particular steel. In the design and manufacture of tablet compression tooling, nothing is more important than the quality of the materials being used. The best manufacturing principals maintaining the tightest tolerances will result in tool failure if the initial material quality is poor. Material quality is the fundamental building block upon which all successive value added steps are laid. The majority of all tablet compression tooling is produced from steel and steel quality is the subject of this article.
More info >>

 
Industry Events

12th Annual Parallel Trade

6-7 February 2018, Holiday Inn Kensington Forum, London, UK

SMi Group is proud to announce the return of Europe’s only Parallel Trade conference. Back for the 12thyear, Parallel Trade returns to London on 6th-7th February 2018.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement