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.

Adverse Event Compliance in Drug and Biologic Clinical Trials, the management report from FDAnews gives dependable guidance on adverse event reporting specifically for drug and biologic companies. Make sense of the key rules and requirements of the FDA and the OHRP and find out what the FDA considers a reportable effect.

Published by Euromed Communications, The Clinical Research Manual cuts the risk of outsourcing, connecting you with expert medical and scientific researchers who translate regulations and best practices into real-world guidance. Now, both new and experienced trial managers will find the information they need to set up and run every phase of a program — from drug discovery through postmarketing surveillance — at home or abroad. Receive a free annual update and two free supplements during the first year!

Discover how to make sure your sites comply with Medicare — and the Federal False Claims Act — and properly negotiate your clinical trial budget with this management report from FDAnews — Clinical Trial Billing: Third-Party Reimbursement.

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 Inspections: How to Prevent a Bad Outcome is brought to you by RxTrials Institute. Discover how to confidently navigate the FDA’s inspectional process: before, during and after a GCP inspection. Use the clinical trial compliance tool created by a former FDA inspector, customize an auditing checklist and capture your most critical endpoint data, and put best practices to work when auditing and training your research staff.

From RxTrials Institute, Clinical Trial Site Selection: Strategies to Gain a Competitive Advantage ensures the research sites you select will meet your needs. You’ll discover proactive pointers to help you find out — fast — if a research site can recruit the subjects you need, think outside the “draft protocol” box, and make sure that your sites share risk with you.

Clinical Trials Indemnification Clauses: Pitfalls and Problems to Avoid is the management report that examines the most problematic areas in negotiating indemnification clauses. This report highlights the key topics you need to address and provides insight into the types of agreements that are generally accepted standards in the industry.

The answers you need are as close as your nearest trial-site computer — when you order the Clinical Trials Online Library, your staff saves time with searchable access to these FDAnews books and management reports, plus key regulatory documents.

Packed with FDA guidance, plus analysis of how issues are reshaping clinical trial conduct and compliance, this book maps out the right way to run a DMC and use it effectively to ensure safety, minimize delays and cut losses at the earliest possible point. Available as a book/CD-ROM set or individually.

If you don't know the prescription-drug marketing law in a particular state, you risk multimillion-dollar fines, penalties, injunctions, seizures ... even disgorgement. Compliance With Changing State Pharma Marketing Laws maps out exactly what laws apply in each state.

Contract Research Organizations in Asia 2008 is the research report and directory that will help you find partners in 11 countries to assist you in carrying out safe, accurate and compliant clinical trials. In addition, this report provides an overview of the growth of trials in this part of the world along with Asian healthcare and industry statistics. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided more than 200 companies with regulatory information and business strategies to develop Asian markets.

No more sifting through mountains of data! Gain easy, CD-access to a comprehensive collection of documents that helps you establish and maintain an eCTD protocol, with the eCTD Digital Handbook from FDAnews.

Effective Techniques for Monitoring Medical Devices in Clinical Trials, the management report brought to you by RxTrials Institute. Discover the details that will help you quickly distinguish between unanticipated adverse device effects (UADE), adverse events and procedural complications from operator error and reporting each event with confidence, understand the relationship between good clinical practice (GCP) and the monitoring of your medical device trials, and accurately apply risk management principles to GCPs.

Just released by RxTrials Institute, FDA Clinical Trial Registries: Future Compliance Challenges in 2008 and Beyond, the management report that will get you prepared for the reporting requirements of today and tomorrow. Everyone involved in clinical trials — sites, sponsors and CROs — needs to know what is required. This report includes all the relevant laws and regulations, as well as the government’s definitions for data elements and the FDA’s current thinking on trials for serious or life-threatening diseases and conditions.