About-Us

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New Chemical Entity (NCE)

A drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. An NCE is a molecule developed by the innovator company in the early drug discovery stage, which after undergoing clinical trials could translate into a drug that could be a cure for some disease. Synthesis of an NCE is the first step in the process of drug development.

About-Us

Mission

The aim of the GCP HelpDesk is to create “one-stop " platform for all the clinical research professionals, enquiring about any GCP related matters and encourage the practice of common, high-quality standards in all stages of clinical research throughout the world.

Objectives

To assist Physicians/Principal Investigators (PIs) in Clinical research on Good Clinical Practice (GCP) matters. Physicians/Principal Investigators and Clinical Research Coordinators (CRCs) are GCP HelpDesk´s main target users
To promote the highest standards for Good Clinical Practice (GCP) in the world
To promote GCP education and awareness

What does GCP HelpDesk offer?

Website
Detailed information on the GCP issues involved in Clinical Research and Drug Development, regulatory formalities/documents, FAQs, glossary, news and other Clinical Research resources.

HelpDesk
Personalized answers to your specific GCP-related queries, delivered by industry experts by e-mail.

FAQs

Latest news and events related to GCP

GCP focus Bulletin

Our journal on GCP with expert articles and practical sections, published quarterly.

Forum

Opinion Poll

What do you think, which of following is the major factor at site likely to impact data Quality?

	Compliance (Protocol, Governing SOPs & applicable regulatory requirements)
	Data accuracy, completeness and credibility
	Patient pool
	Staff resource and management
	Training and ongoing guidance
	Record retention/Archival
	Medical practices

This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

World Generic Medicines Congress Europe 2012 (28/02/12)

Cell Culture World Congress 2012 (28/02/12)

ADVANCED PHARMACOVIGILANCE (14/03/12)

SUCCESSFUL MEDICAL WRITING (14/03/12)

Opinion Poll

Links