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Declaration of Helsinki
2008 adopted in Seoul

Advance news items

Clinical research news is breaking all of the time. Both  CRAdvisor and CQAdvisor newsletters provide reviews and summaries of the latest requirements. In addition, we plan to offer our readers the chance to learn about the latest developments even faster. Our bulletins on this website will provide information even faster than the newsletter.

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Declaration of Helsinki 2008

ISBN 978-1-903712-65-8

Pocketbook size (A6), 8 pages

Can be customised (cover and logo), large orders only

Order your copy now, price £4 (ex P & P)

info@canarybooks.com

Coming soon
 

A new publication will be available soon....

Essential Good Clinical Practice

by Professor David Hutchinson

An essential guide to GCP for sponsors and investigators

New Publication

Sample pages

New Publication

Sample pages

A summary of
Regulations and guidelines affecting clinical research in the ICH regions

A new book will be available soon (end May 2008).
ISBN 978-1-903712-45-0

The book is an ideal companion for investigators and clinical research team members in sponsor companies — as a reference and to support knowledge and training.

The 34 page A5 size book provides a short summary about each requirement
It does not contain the guidance/regulation itself. See the sample pages.

It contains chapters containing executive summaries of

- the ICH guidelines (E section)
- subdivisions of the FDA, EMEA and Japan's MHLW
- key US regulations (21 CFR Parts 11, 50, 54, 56, 312, 812 and the FDAAA 2007)
- Rules governing medicinal products in Europe (Volumes 1-10)
- key EU Directives (2001/20, 2005/28, 2003/94, 95/46)
- forms commonly used in the USA and Europe

Click books for more information, order from our Internet bookshop

View sample

An introduction to the new product development process

ISBN 978-1-903712-53-X

Part 1 of a new factsheet series that can be used individually or collectively

A 4-page, quick and easy to read, illustrated guide explaining in plain language - the types of product (pharmaceuticals & biotechnology) - the traditional phases of product development (Phases I to IV) - the types of trial undertaken in each development phase - trials in special populations.

Available printed (at £5.50 per copy*) or provided as a PDF for an intranet (£250).
Discounts for large orders (100+) — contact us info@canarybooks.com

The factsheet be fully customised in corporate colours with logo.

Order from our Internet bookshop

Special bonus
issues of
CRAdvisor

including review
of PIC/S guidance
CRAdvisor Issue 218

Nine special issues of CRAdvisor have been published electronically.
These are now freely available from this website. No equivalent paper version will be available.

Issues include a review of the requirements for computerised systems (PIC/S), inspection findings and FDA warning letter reviews.

Issues 216 to 219 and 221 to 225 are now available to view and download. Issue 220 is a regular subscription issue.

 Find out more

Newsletter subject index and links to PDFs

A Subscribers Only Section

An index to articles published in CRAdvisor and CQAdvisor since issue 1 in 1997/8 is available on this website. Click Newsletters from the Home page and follow the link.

The index is arranged alphabetically, classified by subject. You can use the identified references to locate the relevant article in your back issues of the newsletter.

Get your user name and password to access this section of the site by emailing your subscription number to:  info@canarybooks.com

BARQA publications

The British Association of Research Quality Assurance (BARQA) has an extensive range of useful publications available via this site.

 See the BARQA publications section for more information.