Clinical Trials and COVID-19: Challenges and Guidance

As the COVID-19 pandemic unfolds, pharmaceutical, biologic, and medical device companies conducting or planning to conduct clinical trials may be faced with challenges related to quarantines, travel limitations, site closures or access restrictions, infection transmission concerns of site research personnel and study subjects. These companies want to ensure that the trial participant’s safety and the […]

Reflecting on Women Who Lead in Life Sciences

Last week, my colleague Dana George and I had the opportunity to attend San Francisco Business Times’ Women Who Lead in Life Sciences event. The event featured a panel of women in top roles at life science companies, who spoke about their personal stories and the most current challenges facing women in the life science […]

Technologies are delivering health data more quickly. What risks should companies be aware of?

Anyone can see that technology is making health care easier and faster. And people are eager to embrace it, as they wear devices that track their vital signs and movements around the clock, and order at-home genetic screening kits to learn about their DNA. On top of that, new advances in non-invasive testing and analysis mean patients can get a diagnosis more quickly than […]

Keep your foreign clinical trials on track with the best insurance coverage

Medical research, whether it’s part of developing a pharmaceutical or a medical device, sometimes needs to take place in a faraway country. Most often, companies are seeking the most relevant pool of patients.  As companies prepare for their first-ever overseas trials, few think of this one critical thing until very late in their preparations: Getting the appropriate insurance. Yet, […]

Are you ready for Sunshine?

Are you ready for Sunshine? Surrounding a company with great partners and advice to mitigate risk in advance of potential litigation is often the best strategy to address the total cost of risk. Carolyn Bruguera, Esq. from R-Squared Services & Solutions, Inc., consults with companies on best practices with respect to the Sunshine Act, and […]

Product Recall: Is Your Company Covered?

If you are a life science company who manufactures your own products or have your products manufactured by others, you have a Product Recall exposure.  Today, addressing and planning for a product recall is a critical element of risk management.  Recalls can affect a company in two ways; an immediate tangible economic loss to your […]