RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Novella Clinical, Inc., a full service contract research organization, today announced Catherine (Cathy) A. Tyner has joined the company as executive director, oversight group management. In conjunction with Tyner’s hire, Novella also announced an expansion of 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)
• Advisory Groups (AGs)
Under 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 center; DMC/DSMB data and statistical support center; meeting planning and conduct; and administration of member contracts and payments.
As a result, Novella’s clients will have access to more extensive oversight group infrastructure, encompassing a broadened network of qualified oversight group members, established operating procedures and innovative systems.
“The use and requirements of oversight groups are complex and dynamic – especially when multiple groups are utilized on the same trial,” commented Tyner. “Many Sponsors will benefit from experienced guidance in navigating, integrating and optimizing these processes.”
Tyner has more than fourteen years experience in clinical research, with a primary focus on the delivery of oversight group services for more than 250 trials spanning phases I-IV and a wide number of indications. A frequent author and speaker, she is internationally recognized as a leader in oversight group process design and has initiated and driven efforts to establish industry standards for oversight group operations.
In her new role, Tyner plans to leverage Novella’s rich eClinical history and leadership to advance the technical solutions which are available to support oversight group operations.
She explained, “Significant benefits can be gained by utilizing technology to facilitate the data reviews conducted by all five types of clinical oversight groups. Delivering the full scope of oversight group activities through an industry-leading, integrated electronic platform is a natural progression for Novella’s eClinical model.”
Tyner joins Novella 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. Her geographic experience spans North America, South America, Europe, India and Asia. She holds a Bachelor’s degree from Wake Forest University and two Master’s degrees from Bowling Green State University.
“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,” noted Rob King, chief operating officer, Novella Clinical.
King continued, “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.”
About Novella Clinical
Novella Clinical, Inc. is a full service contract research organization headquartered in Research Triangle Park, N.C. For more than a decade, Novella has served as an active partner to the oncology, biopharma and medical device industries. As the first global eCRO, Novella integrates deep clinical expertise with industry-leading technologies and a proven approach to support, streamline and expertly resource the entire product development process. For more information, visit www.novellaclinical.com.
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