This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

ACE Releases New White Paper Examining Insurance And Risk Management Considerations Related To Compassionate Drug Use During Clinical Trials

ACE USA, the U.S.-based retail operations of the ACE Group, today announced the release of a white paper exploring the insurance and risk management issues that life sciences companies face when conducting clinical trials for new drugs and medical devices – when they may be in demand for “compassionate drug use.”

“Compassionate Use: Balancing Compassion and Risk in Clinical Trials,” was authored by Justine Cuccia, Esq., Underwriter, ACE USA Medical Risk & Life Sciences, and it discusses the issues that both life sciences companies and patients face. According to Ms. Cuccia, “Life sciences companies can help mitigate potential risks by managing patient expectations and make sure the roles and responsibilities of all those involved in clinical trials are clearly defined through documentation.”

“Compassionate use drug conflicts are on the rise,” said Tristan Gabriel, Senior Vice President, ACE USA Life Sciences, “as more patients seek access to clinical trial products as a last resort. For pharmaceutical and medical device companies, the choice can be very hard. The human factor is clearly a prime concern. However, everyone involved in the clinical trial process needs to be aware of the increased overall risks of the demand for earlier access to promising products and devices. To ensure proper protection, it is vital that life sciences companies ensure a thorough risk management program for protecting all the parties involved. By planning ahead, the risk of conflicts resulting from patient requests can be effectively managed.”

Two recent court cases detailed in the report shed light on the difficult choices that life science companies must make with regard to compassionate use requests and underscore the importance of communication as well as clear documentation by the drug or device company, their risk managers and counsel, when agreeing to any type of compassionate drug use.

As part of a thorough risk management program, life science companies should partner with an insurer who has significant experience in human clinical trials and compassionate use situations, in addition to the following key attributes:
  • An understanding of the applicable regulations
  • A specialization in this type of coverage, to understand the risks involved regarding consent forms and clinical trial agreements
  • An ability to identify emerging risks from overall clinical trial experience
  • Financial strength and an excellent reputation
  • The ability to offer a broad range of products
  • For international companies, worldwide coverage offerings, with locally admitted policies

To access the report, please visit our website. The material presented in this report is not intended to provide legal or other expert advice. It is presented as informational only. Readers should consult legal counsel or other experts, as applicable, with any specific questions they may have.

ACE Medical Risk & Life Sciences, a division of ACE USA, provides primary and excess medical professional liability for hospitals, miscellaneous healthcare facilities, and managed care errors and omissions coverage. In addition, ACE offers products liability for clinical trials, biotechnology, and specialty pharmaceutical companies, as well as a comprehensive package policy that includes property, auto and crime coverages through its Life Sciences unit. To learn more about ACE’s Medical Liability products and services, please visit our website.

Insurance is provided by insurance companies within the ACE Group. All products may not be available in all jurisdictions. The product information above is a summary only. The insurance policy actually issued contains the terms and limits of the contract.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.99 0.31%
FB $102.01 0.10%
GOOG $682.40 -0.10%
TSLA $151.04 0.38%
YHOO $27.04 1.05%


Chart of I:DJI
DOW 15,973.84 +313.66 2.00%
S&P 500 1,864.78 +35.70 1.95%
NASDAQ 4,337.5120 +70.6750 1.66%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs