Nancy Yovetich, Ph.D.
Principal Research Scientist
Nancy Yovetich, Ph.D.
Principal Research Scientist
Dr. Nancy Yovetich is a Principal Research Scientist who has been involved in the research of psychiatric, neurologic and analgesic therapies for more than 25 years. Her responsibilities have included study design, protocol writing, project and clinical study management, data management, analysis and report writing.
A frequently-cited author, Dr. Yovetich has written scientific and medical articles in the related areas of the aging process, the dually-diagnosed homeless population (substance abuse and psychiatric illness), and pediatric patients with sickle cell disease and prior stroke. Her specific indication experience includes Alzheimer’s disease (2 studies), traumatic brain injury (3 studies), stroke (5 studies), and analgesia (30 studies).
Continually displaying her broad range of clinical research expertise, Dr. Yovetich has served as the Principal Investigator on the NIH walk-PHaSST study that assessed the use of sildenafil to treat patients with sickle cell disease and pulmonary hypertension. She has been the Principal Investigator on Rho’s Clinical Research and Operations Management contract with the National Institute of Dental and Craniofacial Research for more than 10 years, and also led multiple commercial research programs on medical devices.
Known for her ability to save the day, Dr. Yovetich led a rescue operation of a 23-study clinical program of an analgesic patch for which the sponsor came to Rho after the FDA had rejected the sponsor’s new drug application (NDA) due to errors and inconsistencies in the safety data. Her team at Rho performed a careful analysis of the issues found within the data, resolved those issues by querying sites from all studies, cleaned and relocked the data, reanalyzed the data and prepared revised study reports for submission. With the addition of another set of studies, the resubmission was ultimately approved by the FDA.
Dr. Yovetich has many years of successful process development and process enhancement experience through both her role as a department director within Rho as well as her consulting experience with clients of Rho. As part of the NIDCR-CROMS contract, Dr. Yovetich facilitated the development of more than 75 clinical research tools that are publicly available through the NIDCR’s clinical toolkit).
She has also facilitated a multi-institute group of program officials in the development of a standardized protocol template for behavioral science researchers.
Dr. Yovetich also facilitated a team from affiliated multinational drug development companies to harmonize standard operating procedures.
Dr. Yovetich earned her Ph.D. from the University of North Carolina at Chapel Hill in Experimental Social Psychology with a minor in statistical methodology.
Why Neurology and Analgesia?
“I enjoy research in neurology, and specifically analgesia, because I personally know so many people whose lives have been negatively affected by pain. I am also fascinated by the methodological challenges of working on a subjective endpoint of this nature. For example, researchers and statisticians must anticipate the very real impact that the placebo effect has on the subjective reporting of pain as they design and power the studies. I would love to be involved in research to identify more objective assessments of pain than the customary self-report measures.”
This is what drives Dr. Yovetich:
“I enjoy working for a contract research organization because of the variety of studies I have the opportunity to work on. I find it satisfying to lend my expertise to a familiar therapeutic area as well as to dig into a new therapeutic area, taking advantage of my large network of resources to quickly learn the important aspects of that area. In all cases, I leverage my affinity for process enhancement to ensure a high functioning project. I have led several studies/programs where Rho has been brought in to rescue a faltering study. I have reviewed and analyzed the situation, introducing new and efficient processes and reporting tools that ultimately led to the program’s success. I strive to create a true partnership between Rho and the sponsor and to provide the highest level of customer service. This approach, along with my excellent project teams, has led to very high percentages of repeat business both from project to project within a sponsor company and from individuals who move from sponsor to sponsor and come back to Rho with new projects at their new companies.”
Content by Nancy Yovetich, Ph.D.
Completing enrollment is typically one of the most critical milestones in a clinical trial. Enrollment delays impact the study budget, site resources, and downstream timelines. Therefore, it is important to identify potential risks to enrollment early in the study, even during the protocol development process if possible. Defining risk mitigation strategies and setting quality tolerance limits allows the study team to quickly identify when a strategy must be implemented to keep enrollment on track. In this webinar, we will discuss how we have used a risk-based quality management system to document enrollment risks and creative solutions we have implemented.