International Clinical Trials How to Bulletproof Your Clinical Trial Agreements
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:
- The 8 land mines lurking in international clinical trial agreements
- 2 recent CTA-related cases and what they can teach about best practices
- Creative plaintiff allegations — breach of the right to be treated with dignity, violation of civil rights, libel/slander
- The insurance you need, and how to negotiate the best deal for it
- 7 tips to minimize pitfalls of informed consent
- What to include in checklists given to overseas trial sites and investigators
- Clarifying roles and responsibilities of sponsors, investigators and IRBs
- Transferring obligations to a CRO — what must be put in writing
- Current regulatory interpretations of 21 CFR 50, 56,312, 812 and ICH GCP
- And much more!
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?