Clinical Trials

The FDA recognizes that there have been “dramatic changes” in how clinical trials are conducted and monitored.

Modernize your company’s policies and protocols to place your company at the forefront of the quickly evolving clinical trials landscape.

In the last year, between the issuance of final and proposed regulations on clinical trials conduct and unprecedented government and public scrutiny of trials, structuring and conducting safe and compliant clinical trials has never been a more difficult task. Undoubtedly, there will be even more challenges and new demands on even the most seasoned clinical trials professionals in the months to come. In light of the complexity facing the clinical trials world, ACI’s 14th Advanced Forum on Clinical Trials provides a comprehensive forum for the key stakeholders — current and former government enforcers, top in-house counsel from sponsor biopharmaceutical and medical device companies, CROS, hospitals, universities, and research institutions — to unite and share best practices when structuring a safe and compliant clinical trials program which maximizes data integrity and human subject protection.

More is at stake than ever with record-breaking fines and criminal and civil liability.

The continued and steady stream of high-profile investigations into biopharmaceutical and device companies’ clinical studies data integrity makes it abundantly clear that it is imperative to have triage plans in place to weather the storm of criminal and civil liability stemming from clinical trial research.

Successful clinical trials are essential to a company’s pipeline and market share. Attendees of this event will:

• Hear directly from the FDA and DOJ and several former federal prosecutors on how to guard proactively against impermissible behavior during a clinical trial
• Heighten patient protection throughout your clinical trials by learning inside compliance tips and strategies from counsel from Hospital Corporation of America, University of Pennsylvania, and more…
• Facilitate drug approval and protect market share as you share best practices with the experts who already have put established large-scale trials together including representatives from Abbott Laboratories, GE Healthcare, Johnson & Johnson, The Medicines Company, Prometheus Laboratories, Rigel Pharmaceuticals and more…
• Gain insider tips to ensure compliance, minimize liability, and adhere to good clinical practices when conducting clinical trials domestically and internationally in the face of new developments with informed consent, post-marketing studies, risk-based monitoring
• Find out best practices for keeping up to date with numerous scientifi c and technical advances including the cultural permeation of social media and the reality of biosimilar clinical trials

Over the years, previous attendees have demanded even more in-depth information on the logistical and practical challenges of running a trial, so this year we are pleased to present two highly in-depth sessions run by practitioners in the trenches: The Nuts-and-Bolts of Structuring and Carrying Out Large Scale International Clinical Trials and Clinical Trials for Medical Device Companies.

Don’t hesitate- streamlined and safe clinical trials are crucial to the continued success of your company. Call 888-224-2480, fax your registration form to 877-927-1563 or register on-line at www.AmericanConference.com/ClinicalTrials to ensure that you have a spot among your peers at this summit of the leaders in the clinical trials industry.

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