CRO-CSO, Contract Organizations

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Industry, Regulators Move to Adopt Quality Standards

Harmonization spurs efforts to implement modern manufacturing systems and risk-management programs.

Date: 02/01/2007 , Publication: Pharmaceutical Technology , Author: Jill Wechsler

http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=400644

Trial Catastrophe Lends Impetus to Reform

UK report on last year's TGN 1412 trial provides industry with blueprint for improved early clinical studies.

Date: 02/01/2007 , Publication: Applied Clinical Trials , Author: Peter O'Donnell

http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=4

India: Give or Take?

Responsibility is key to giving back to the research-rich country.

Date: 02/01/2007 , Publication: Applied Clinical Trials , Author: Nigel Page

http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=4

Justifying the Means

Much can be said for the ethics of innovation.

Date: 02/01/2007 , Publication: Pharmaceutical Technology , Author: Kaylynn Chiarello-Ebner

http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=400641

Change Is Not Consolidation

A seemingly endless stream of new alliances surfaced in recent months

Date: 02/01/2007 , Publication: Applied Clinical Trials , Author: Robert Davidson

http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=4

Central vs. Local: Rethinking IRBs

Regulators and sponsors encourage alternative review models to fit a growing research enterprise.

Date: 02/01/2007 , Publication: Applied Clinical Trials , Author: Jill Wechsler

http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=4

Innovations in API Synthesis

As custom manufacturers gather for InformexUSA this month, strategies in asymmetric synthesis and catalysis prevail.

Date: 02/01/2007 , Publication: Pharmaceutical Technology , Author: Patricia Van Arnum

http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=400918

STED Pilot Program

The Summary Technical Document (STED) format for regulatory submissions is a harmonized submission format developed by the Global Harmonization Task Force (GHTF)...

Date: 01/19/2007 , Publication: FDA-CDRH , Author: FDA

http://www.fda.gov/cdrh/sted/

2007 and the Road Ahead

Judging from the last quarter of 2006, the year ahead promises to be chock full of surprises and compromises in both drug development and health-care cost discussions

Date: 01/01/2007 , Publication: Applied Clinical Trials , Author: Toby Jane Hindin, EdD

http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=3

Clinical Trials Listing from the FDA by Alphabetical Order

You can include trials that are no longer recruiting patients.

Date: 01/01/2007 , Publication: FDA , Author: FDA

http://clinicaltrials.gov/ct/screen/BrowseAny?path=%2Fbrowse%2Fby-condition%2Fa

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Search returned 105 items.