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

Clinical Evaluation Report (CER)

Revision 4 Clarifies the Clinical Evaluation Report (CER)

Clinical Evaluation: MEDDEV 2.7/1 Revision 4 A new guidance document for Clinical Evaluation (MEDDEV 2.7/1 Rev. 4) was released this summer providing new requirements and much-needed clarification in several areas. The new guidance offers clarity around writing a fully compliant … Read More

process performance

Analyzing Process Data to Optimize Clinical Trials

This is part three in a series describing how Novella Clinical’s Business Optimization department uses process data and analytics to improve delivery for our customers.   In our first two posts we discussed how predictive analytics can influence clinical trial … Read More

immunotherapy clinical trials

Answering Your Toughest Immunotherapy Clinical Trials Questions

Small to midsize biopharmaceutical companies play significant, pioneering roles in innovating novel cancer therapeutics, particularly with the new wave of immunotherapeutic agents. They also have plenty of questions about clinical trial hurdles unique to this class of drugs — one … Read More