Clinical trials are complicated enough. Move them overseas and the complexities proliferate. Untrained, unsupervised IRBs ... Inadequate in-country resources ... credential fraud and misrepresentation ... cultural and language barriers ... negative PR from trials gone bad ... political corruption and bribery ... the list is long.
And the stakes keep growing. Did you know ... warning letters due to clinical trial problems more than doubled from 2006 to 2009.
Stronger agreements are the answer. You need a lawyer’s advice ... without paying a lawyer’s fee. FDAnews has invited a leading litigator, Chris Johnson of Shook Hardy & Bacon, to help you bulletproof your international clinical trial agreements.
Without leaving your desk, you’ll learn the basics of drafting clinical trial agreements, international and domestic. You’ll cover key elements of ironclad agreements ... hear tips to mitigate risks ... review case studies of recent litigations ... get checklists for creating agreements ... and take away sample agreements to study at your leisure. Presentation specifics include:
It’s 90 nonstop minutes of interactive learning. And because the session takes place via the web, you’ll have every opportunity to get answers to questions you email the presenter.
Make sure everyone in your company is on hand who deals with international clinical trials. There’s no limit on number of participants at one location; the price is the same regardless of how many log on.
Stop worrying whether the FDA or some overseas regulator will block your trials. Properly drafted CTAs are the answer to regulatory hurdles and lawsuits, and the path to greater clinical-trial success. Can you afford not to sign up?
Chris Johnson is a partner in the San Francisco office of Shook Hardy & Bacon, specializing in medical, scientific and statistical defense strategies in complex civil litigations. International clinical trials are a focus of his work. He has assembled an in-house team of allied medical and scientific professionals to conduct medical case review and research.
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