Account

Sign in to access your account and subscription

Practice Tip: Keys to Successful Negotiation of Clinical Trial Agreements

Clinical trial agreement ("CTA") negotiation has become the most common cause of delay in studies. Because the cost of bringing a new drug to market is astronomical, pharmaceutical companies typically lose millions of dollars per week as a result of any delay in the process.

21 minute read November 24, 2009 at 12:36 PM
By
Michelle M. Bufano and Natalie H. Mantell
Practice Tip: Keys to Successful Negotiation of Clinical Trial Agreements

Clinical (human) trials are essential to pharmaceutical companies that develop and market new drugs. They are required by the United States Food & Drug Administration (“FDA”) both prior to approval of the drug for marketing, and during post-approval marketing, as a means of evaluating the drug's safety and efficacy.

This premium content is locked for LawJournalNewsletters subscribers only

ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN LawJournalNewsletters

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

Already have an account? Sign In Now

For enterprise-wide or corporate access, please contact Customer Service at [email protected] or call 1-877-256-2473.

NOT FOR REPRINT

© 2026 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.

Continue Reading

The combination of increasing operating costs and uncertain government reimbursement funding continues to place health care providers under financial pressure, and in many cases, financial distress. Given the importance of Medicare/Medicaid funding of claims under provider agreements with the federal government, how courts interpret and apply the interplay between the Bankruptcy Code and Medicare Program Act determines the disposition of hundreds of millions of dollars of claims for reimbursement that support the health care system.

April 30, 2026

As AI becomes embedded in everyday business and legal operations, organizations are confronting a new expectation: simply disclosing AI use is no longer enough. A critical shift is taking place in the legal industry: transparency is no longer just about disclosure; it’s about comprehension.

April 30, 2026