Clinical research organization Novella Clinical hopes Cathy Tyner can translate the clinical oversight work she pioneered at Quintiles into a comprehensive offering for Novella and a competitive edge against other mid-sized CROs.
Tyner was been hired by Durham-based Novella as executive director, oversight group management. In that role, she will oversee third parties that are part of clinical trial safety, including data monitoring committees, data safety monitoring boards and clinical endpoint committees.
While such groups were part of what were considered best practices for clinical trials, it is only relatively recently that their role has become a more formal part of the clinical trial process, Novella spokeswoman Jessica Cunningham said. Regulators have been calling for more oversight groups in clinical trials as well as post-marketing safety studies. With Tyner’s hire, Novella is expanding its services related to these oversight groups.
Tyner brings to Novella about 14 years of clinical research experience with Quintiles. She founded the Quintiles department that specializes in clinical oversight group management services. Novella believes having a department dedicated to such oversight groups could set it apart from other CROs. While these services are in place at large firms such as Quintiles they are not as common among smaller CROs.
Novella is a mid-sized CRO with more than $105 million in annual revenue. Novella provides contract services to small and mid-sized pharmaceutical and medical device companies. Besides organic growth, the company’s growth has been aided by acquisitions. Last year, Novella acquired Ohio CRO Prologue Research International, which offered oncology expertise. Novella has a clinical services agreement with Colorado firm OSI Pharmaceuticals, which gives the company additional oncology expertise as well as expertise in diabetes and obesity.
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