liquid biopsy technology

Harnessing Liquid Biopsies in Clinical Trials

Liquid biopsy technology is emerging as an enormously promising tool in the fight against cancer. Because it can detect changes in tumor genetics well before imaging reveals changes in growth, it has the potential to enable earlier intervention or treatment … Read More

Cures Act

21st Century Cures Act Spurs Medical Device Opportunities

The 21st Century Cures Act (the Cures Act) includes many significant changes to the regulatory landscape for medical devices. Signed into law by former President Barack Obama on December 13, 2016, with overwhelming support in the House (392-26) and Senate … Read More

dermatology division

Novella Clinical Welcomes Dermatology Division

The New Year is off to a swift start here at Novella Clinical following an eventful 2016. Last month was especially exciting as we welcomed a new division through the acquisition of the Phase II-IV Clinical Trials Division (CTD) of … Read More

rescue study

When it’s time to rescue a study

Planning and executing a global, interventional medical device study is a complex process. Whether you’re managing the study internally or partnering with a qualified CRO, there are times when studies may not go as planned. If multiple problems arise that … Read More

TMVR

Overcoming Obstacles to TMVR Device Approval

I recently contributed an article and perspective for MD+DI regarding challenges ahead for TMVR, or transcatheter mitral valve replacement. Although the technology has not seen the rapid clinical success and adoption of its cardiological cousin, TAVR, or transcatheter aortic valve … Read More