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

TAVR procedure

TAVR Procedure: Clinical Studies Keeping Pace with Innovation

Those of us who attended EuroPCR 2016 may recall the discussion between cardiologists and cardiac surgeons regarding whether or not transcatheter aortic valve replacement (TAVR) should be used in lower surgical risk patients. Generally, the cardiologists gave the procedural intervention … Read More

Oncology CRO

Novella Clinical Executive Named to PharmaVOICE 100

Since 2005, PharmaVOICE has honored innovative scientists through its PharmaVOICE 100. Scientists are selected for their contributions to the life sciences industry, specifically, their leadership, management, knowledge, and willingness to tackle major industry challenges – and the inspiration they bring. This … Read More

European Accelerated Regulatory Pathways Show Momentum

The European Medicines Agency (EMA) has launched a new expedited approval pathway similar to those available in the US to facilitate access to medicines for patients in the European Union (EU). European regulators introduced the PRIority MEdicines (PRIME) approval pathway … Read More

Physician Spotlight

Dr. Leslie Clapp: Excellence in Clinical Research and Guidance

For more than 25 years, Leslie Clapp, M.D., F.A.A.P., has excelled in her career, as a pediatrician, and now as Novella Clinical’s Executive Medical Director, responsible for helping ensure the safety of patients during clinical trials. In addition to academic honors, … Read More

process data

Using Process Data to Understand Current Performance

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

Medical Device Development

Medical Device Development: Distinctions Matter in Clinical Studies

Developing medical device clinical trials for investigational Class II or Class III devices typically means planning around a lot of moving parts that aren’t normally factors in drug studies. Devices are often engineered to have multiple components—hardware, software and/or medicinal … Read More