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Event Details
The FDA has dramatically stepped up enforcement of clinical trials. In 2009 alone the agency increased FDA sponsor inspections some 70 percent and will likely become even more aggressive as the number of clinical trials rise in light of new regulations and changes to the 510(K) program.
With all that rides on chosing the right partner for a clinical trial, it's imperative to get the decision right.
This webinar will provide you with all the tools you need to make the right decisions about picking and working with the right CRO for your clinical trials.
Five lessons you'll take away:
- What is the best approach to picking a contract research organization, is bigger always better?
- What are the most important things to look for in picking a partner. Do you know what questions to ask? Do you know what the FDA is looking for in its oversight of clinical trial?
- How to create and meet reasonable timelines for partners, investors and other stakeholders
- How to measure progress, risk analysis and other execution time lines
- What are the best practices in conducting meaningful clinical trials?
Join MassDevice along with experts Laurie Halloran, CEO of Halloran Consulting and John Lewis, Vice President of Public Affairs for the Association of Clinical Research Organizations for this can't miss opportunity.
About our experts:
Laurie Halloran founded Halloran Consulting Group in 1998. With over 20 years
of experience in clinical affairs management with contract research
organizations and biotechnology companies, Laurie is recognized as an
industry expert in improving the organizational effectiveness of
clinical research programs with a specialty in gap analysis and
strategic planning. Laurie has executed over 25 clinical trials from
Phase I to Phase III for both emerging and established companies and
has managed operational budgets of up to $24 MM.
John Lewis, Vice President of Public Affairs Association of Clinical Research Organizations has 20 years of experience
in communications, marketing and public affairs in the health care, financial
services and technology industries. Prior to joining ACRO, John provided
strategic marketing and public relations consulting services to a variety of
companies, including CROs. For two years, he directed all marketing, public
relations and investor relations activities for a global CRO.
Registration includes:
- One phone line per person
- Ability to ask questions live on the call or via chat function
- E-book on picking the right CRO
- Registrations are transferable but not refundable.
In order to purchase these tickets in installments, you'll need an Eventbrite account. Log in or sign up for a free account to continue.