Novella Launches Clinical Oversight Services

Catherine (Cathy) A. Tyner has joined Novella Clinical, Inc. as executive director, oversight group management. Novella has also expanded services related to the integrated design and implementation of clinical oversight groups, including: Data Monitoring Committees (DMCs) / Data Safety Monitoring Boards (DSMBs), Clinical Endpoint Committees (CECs), Medical Decision Committees (MDCs), Core Laboratories (CLs), and Advisory Groups (AGs).

Under Ms. Tyner’s leadership, Novella will provide enhanced oversight group services to clients, including membership selection, process consulting, design and implementation, development of charters, CEC/MDC/CL data coordinating, DMC/DSMB data and statistical support, meeting planning and conduct, and administration of member contracts and payments.

Ms. Tyner has more than 14 years of experience in clinical research, with a primary focus on oversight group services for trials spanning Phases I-IV in a variety of indications. She joins the company from Quintiles, where she held positions of increasing global responsibility in oversight group management and safety, most recently serving as a senior director in the Lifecycle Safety unit.

“Cathy’s world-class expertise in the development and management of oversight groups will enhance Novella’s service offerings and add tremendous value to our oncology, biopharma and medical device clients,” said Rob King, chief operating officer, Novella Clinical. “We have seen increasingly rigorous regulatory requirements for incorporation of oversight groups in clinical trials and post-marketing safety surveillance studies, as well as the release of new guidelines requiring endpoint adjudication committees in some settings. Novella’s ability to offer augmented services enables us to partner more effectively with oversight group members while creating efficiencies for our clients.”