View Cart  

Clinical Trial Compliance in Underdeveloped Countries

October 2006
Also Available:

Order your copy today!

Don't let complex foreign laws, practices and customs derail your clinical trial in an underdeveloped country ...

Now you can sidestep some of the most significant risks of conducting trials in underdeveloped countries, with this management report from FDAnews — Clinical Trial Compliance in Underdeveloped Countries.

Order today, and you'll discover how to:

  • Identify and manage the top risks of working in the developing world, including:
    • Political and economic turmoil
    • Corruption and bribery
    • Underlying morbidity of subject populations
    • Daily living as an "adverse event" in an underdeveloped country
    • Obligation to provide standard therapy treatment after trials end
  • Deploy effective methods and strategies for dealing with foreign officials, including:
    • National governments
    • Medicines authorities
    • Ministries of health
  • Prudently approach local partner medical institutions for siting of trials
  • Incorporate key issues when:
    • Drafting informed consent
    • Planning the end of studies
  • Gain a working knowledge of U.S. laws and standards related to payments or bribes offered to foreign government authorities
  • Build a proactive contingency plan for clinical trial disruption
  • And more!

Foreign officials have the power to make or break your clinical trial in a developing country — make sure your interactions are handled with diplomacy. Click here to order.

Get Single-Resource Access
to International Research Regulations

Clinical Trial Compliance in Underdeveloped Countries also delivers single-resource access to:

  • Regulation of international research, including:
    • FDA regulations
    • Office for Human Research Protections
    • Declaration of Helsinki
  • Answers to common questions
  • Strategies for working with local sites and authorities
  • Three appendices, including:
    • The Globalization of Clinical Trials
    • Report of the Equivalent Protections Working Group
    • IRB/IEC Authorization Agreement
  • And more!

Buy Now!
Put strategy-specific advice to work for you — this targeted report includes everything from dealing with national governments to U.S. laws and standards on bribes to foreign officials — click here to order.

Just $297, Clinical Trial Compliance in Underdeveloped Countries is available in print or instantly available for online digital download. Stay informed when you order this comprehensive management report today!

Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.

Interested in Electronic Multi-user Access?
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable.

For more information please contact Customer Service:
Phone:  +1 (703) 538-7600 or toll free (888) 838-5578