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BioResearch Compliance Report


You need the BioResearch Compliance Report now more than ever — save AND be one step ahead of FDA inspectors

Electronic Licensing Available! Click here

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BioResearch Compliance Report, is the monthly publication that analyzes 483s and Establishment Inspection Reports (EIRs) for FDA inspections of clinical investigators, institutional review boards (IRBs), sponsor/monitors, contract research organizations (CROs) and testing labs (GLP).

This is the first publication devoted exclusively to analyzing "BiMo" inspection records.

 

Each issue will:
• Examine 483s, EIRs and responses to determine what questions FDA inspectors are asking clinical research sites and GLP labs, plus IRBs and sponsor/monitors.
• Describe how researchers, sponsors/monitors, IRBs and CROs/testing labs responded to 483s.
• Provide subscribers with copies of 483s, EIRs, company responses and other regulatory documents that are NOT available on the Internet.
• List a log of BiMo inspection requests – see who has been audited.
You also receive weekly E-mail updates on news of clinical research, new approvals, plus FDA and NIH enforcement activities.
Subscribers get UNLIMITED access to our RECORD-RETRIEVE Service to order 483s, EIRs, company responses, warning letters, etc...

Sample of our BioResearch Compliance online news page, click here.

$760---Price includes 12 issues per year, plus weekly email updates and a FREE copy of The Global GCP Compliance Report 2006 - bringing you all the guidance documents and compliance policy guides (CPGs) you need, all in one source. From Barnett International and Washington Information Source!

Foreign Subscribers: Please add $40 for postage. Subscriptions accepted in U.S. dollars only.

The Global GCP Compliance Report-FREE with your new, paid subscription!
The First-Ever Study of Global GCP Clinical Trial Compliance Programs and Trends! From Barnett International and Washington Information Source Co.!

Learn what FDA, EMEA, OHRP, and Japan's PMDA see as the GCP compliance "hot spots" today! Developed for clinical sponsors and CRAs, clinical trial administrators, clinical compliance officers, clinical investigators and site staff, clinical QA professionals, and other clinical professionals!

In The Global GCP Compliance Report, you'll gain access to the following in-depth profiles, compliance data, and interviews.

You can get your copy FREE with your new, paid subscription to BioResearch Compliance Report!

Foreign Subscribers: Please add $40 for postage. Subscriptions accepted in U.S. dollars
only.

Click here to order online or call 703.779.8777.

For any questions or concerns please call 703.779.8777 or email service@fdainfo.com.

Editorial Office: 
Washington Information Source Co.
208 South King Street, #303
Leesburg, VA, 20175
Subscriptions:
Washington Information Source Co.
20940-C Frederick Road, #500
Germantown, MD, 20876-4017


RECORD-RETRIEVE Service: (703) 779-8777 FAX: (703) 779-2508