This new-and-revised collection from FDAnews draws on the experience of thousands of trial sites worldwide. They’re compiled from stories that first appeared in Clinical Trials Advisor newsletter, the industry’s trusted source of management and compliance guidance.

From FDAnews — Adverse Event Compliance in Device and Diagnostics Clinical Trials. Find clear, concise guidelines on adverse event reporting — specifically for device and diagnostics trials. Make sense of all the whats, whens and hows surrounding adverse event reporting. Once an adverse event happens, it’s too late: you have just 10 working days to submit to the IRB and 10 days after that to get results to the FDA. Stay in control, even when unanticipated events happen.

There’s no doubt that these new requirements will increase the regulatory burden on drug and biologics trial sponsors and investigators already laboring under a heavy load. That’s why the new special report Adverse Event Reporting for Drug and Biologics Trials is essential for busy executives involved in clinical trials and regulatory affairs.

This management report from FDAnews provides drugmakers and suppliers with a thorough overview of the EU’s risk management approach.

Before you begin to modify an existing trial, this new report from FDAnews maps out the specific planning and preparation it takes to win FDA approval for adaptive clinical trials. By combining a concise overview with a detailed analysis of FDA’s preferences, this one report advises you on everything thing from the best trial model to use to the best way to avoid technical problems with final data analysis.

As a clinical trial sponsor negotiating a trial budget, you need to clearly understand what costs are billable to third-party payers, including Medicare, before you sign contracts. Failure to properly address this can result in budget problems, inadequate liability coverage, or even fines and other penalties. Here’s how to avoid Medicare billing problems in your clinical trials: Billing Medicare for Clinical Trials Costs: Avoiding Noncompliance and Budgeting Accurately

Produced by the British Pharmacopoeia Commission Secretariat, the British Pharmacopoeia 2012 is the leading collection of standards for UK medicinal products and pharmaceutical substances.

Step-by-step, this report helps you master the many aspects of change control and the many regulations that must be factored into emergency decision-making and routine company procedures.

When it comes to valuing a company’s assets, bricks and mortar are the least of it. For most life sciences companies, the core value of a company’s assets lies in intellectual property — patents, copyrights, trademarks, secret processes.

Glean real-world insight with examples of working change control systems, specifically targeted to the unique needs of drug and biologic manufacturers, with this new management report. Don't delay, order this distinctive management report filled with common sense procedures on change control that you can use today.

Don't miss out! Successfully sidestep the delayed approvals, lost product batches and plummeting profits that can result from change control failures with this comprehensive report. Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers.

China Pharmaceutical Market Report 2011 is the research report that contains key information on important aspects of the Chinese pharmaceutical market. This book provides an overview of current conditions in the Chinese healthcare market. It is an invaluable resource, whether you are planning to expand your reach into China for the first time or simply need a veteran’s perspective on the country’s marketplace to manage your ongoing efforts.

China Pharmaceutical Regulatory Report 2011, the research report that gives you a thorough understanding of the Chinese regulatory structure governing the drug industry. You’ll get a complete discussion of the laws and regulations that govern the testing, product registration, manufacturing, importing, marketing and sales of pharmaceuticals. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided hundreds of companies with regulatory information and business strategies to develop Asian markets.

In this clear yet comprehensive new resource developed by Access China Management Consulting Ltd., FDAnews provides an English-language guide that makes it easier to navigate the Chinese medical device registration system.