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When you’re starting a biotech or device program, everything is urgent. The pace is demanding, the challenges intimidating, and decisions have far-reaching implications.Learn More
Functioning in an organization spanning international borders and clinical regulatory environments means overcoming obstacles, and doing so inside the boundaries of the big picture.Learn More
A company with a culture of great ideas and close collaboration and passion to always do what is right for our clients. We have been assembling the strongest life science consulting team in the business for more than two decades. Attracting the best people is a product of thought leadership, but also of culture.Meet the Team
“His palms are sweaty, knees weak, arms are heavy…” Was Eminem talking about his first encounter with the Center for Devices and Radiological Health (CDRH) at FDA? Why does the anticipation of a first “date” with CDRH send your heart into overdrive? And what do you need to do to prepare adequately so you don’t feel like a hormonal teenager about to go on a first date? Here is what you can you do to ensure success on your “first date” with CDRH – from asking them out to that awkward goodbye. First of all, ask yourself - do I really want to date CDRH? Yes! It’s free and easy. And you can get input into any aspect of your product life cycle, but to make a good impression on that date, you really need to be prepared so you are well regarded from the first interactions. How should you ask them out? Follow the CDRH pre-submission guidance. If you do, you are pretty much guaranteed that they will say yes. Meet the requirements outlined in the pre-submission guidance for a high quality submission (i.e., ensure that it’s organized, clear and concise, and you’ve identified your questions) and ask for a face-to-face meeting, a teleconference, or just a written response. What are you going to talk about? Identify your critical issues – these can vary depending on where you are in your product development cycle. Get early input from all of the appropriate stakeholders and plan to meet regularly with your team. Questions can range from those...Read More » View All Articles
Join us for our New England Clinical Operations Executive Breakfast focusing on How to Use Metrics to Ensure Efficient Clinical Trial Outcomes and…Read More »
Halloran's annual Clinical Operations Retreat (CORE) 2016 will take place September 28 - 30, 2016 at Ocean Edge Resort &…Read More »