Jenny Gidley MBA '07
NC State Graduate Found Jenkins MBA a Perfect Fit
October 01, 2009
“What can I say, I love the sciences.”
That’s how Jenny Gidley explains the academic trek that earned her a bachelor’s degree from North Carolina State University in 1999, in biochemistry and chemistry plus a minor in genetics – an academic foundation that got her started in the bioscience industry.
In 2007, she received an MBA from the NC State College of Management’s Jenkins Graduate School of Management, with a concentration in biosciences management and innovation management. She was one of the first students in the Jenkins MBA to complete the biosciences concentration.
“Clinical research was a natural fit for me with my educational background and strong interest in the medical field and cutting edge research,” she said. “For the past 10 years, I have had various roles in the clinical research arena – monitor, monitor manager and global clinical study manager working for major pharmaceutical companies GSK and Pfizer as well as a global clinical research organization (CRO).”
Gidley also has a passion for patient safety, and that led her to launch her company earlier this year – Total Independent Review Board (Total IRB). It is a Raleigh-based independent review board with the primary responsibility of protecting patients in clinical trials from unnecessary risk or harm. The company has a total of seven employees, with several working remotely. Among those at the office are Cari Newton, client services, and Melinda Cordasco, quality control.
Their offices are adjacent to another NC State alumnus – Jim Saunders, whose company, CISYS LifeSciences, created the technology platform that enables Total IRB to operate in a totally electronic environment.
Saunders has an NC State College of Management connection as well. He is just two courses short of completing his bachelor’s degree in economics. He did graduate from NC State in 1990 with a degree in computer science. He said he had planned to complete the economics degree requirements at the same time, but a shortage of time and resources got in the way. Then he started his business and a family. He said he would like to complete the degree, though.
Jenkins MBA ‘A Perfect Fit’ – Biosciences and Entrepreneurship
Gidley focused her MBA studies on the Jenkins MBA program’s biotechnology and pharmaceutical management concentration, now called the biosciences management concentration. “This was a perfect fit for me,” she said.
“I had reached a point in my career where I felt I needed formal management and business training. It was natural to go back to my alma mater for a graduate degree after my positive undergraduate experience. NCSU’s science and technology focus within the MBA program further bolstered that decision. A class by Dr. LAS – as Professor Lynda-Aimen-Smith is known to her students – on Managing People in the High Tech Environment was very useful, particularly now that I have my own high tech company,” she said.
“Total IRB is almost entirely electronic, with our reviewers based across the entire United States. Thus, the ability to balance managing people remotely coupled with the core presentation skills developed in that class has been invaluable,” Gidley said.
As an MBA student, she also participated in the Jenkins MBA program’s Technology Entrepreneurship and Commercialization (TEC) series of courses, which is now also available as a graduate certificate program for those who have a bachelor’s degree.
“The TEC program provided actual technologies for evaluation – in my team’s case, medical technologies – which we took from initial evaluation of commercially viable product concepts through the business planning cycle into compelling new business opportunities,” Gidley said.
“The structured process for technology evaluation that I learned through the TEC program helped me identify the need for Total Independent Review Board (IRB). My experience in the clinical research field, the skills I learned in my MBA coursework and a spirit of entrepreneurialism facilitated the founding of Total IRB.”
Meeting a Critical Need
Anyone initiating a clinical trial within the United States must receive IRB approval prior to enrolling the first patient, Gidley explained. “This is a critical step in the overall drug development process.” Total IRB’s clients include pharmaceutical companies, CROs, biotechnology companies and individual investigator sites. “We review clinical trials that are to be conducted at locations throughout the United States,” she said.
Her designation as a certified IRB (CIM) manager “gives our clients confidence that not only do I have the clinical and operational experience necessary to run an efficient IRB, but I also have extensive knowledge of the federal regulations and guidelines IRBs must adhere to.”
The company’s review board is composed of a diverse group of independent consultants. “We have a great combination of licensed practicing physicians, a psychologist, nurse, pharmacologist, ethicist and clergyman and specialists from a variety of different educational and work backgrounds,” she said. “We have members from industry, private practice, large institutions, the federal government, as well as local community members. Our scientific members have, on average, more than 20 years of experience across a broad range of therapeutic areas.”
Technology Equals Efficiency
The company was structured to be “technologically savvy,” Gidley said. “We have worked to streamline the entire review process by making everything electronic. We have electronic submissions, e-tracking, e-signature and even e-notification. Our organization is focused on efficiency, simplicity and compliance.”
The hub of the organization is iROC™, “our fully validated, 21 CFR Part 11 compliant, secure online web portal. It’s both an internal and external system so that clients use it for their submissions and correspondence with us, as well as receipt of final documents. Our board members use iROC to review all documents prior to the next board meeting, make notes about questions or comments, approve expedited review materials, and to see all previous submissions for a project. We manage the ethical review of studies from start-up through completion.”
Rapid-turnaround time is a key point of pride for the company, she said. “Every single day is important when trying to get a new drug approved to save lives,” she said.
“The company’s review board members meet weekly and meeting decisions are posted to iROC™ usually within 24 hours of the meeting. As soon as they’re posted, clients get an email notification with a link taking them right to the documents,” she said. The company is not sacrificing quality for the sake of efficiency, though. In fact, quality, integrity and accuracy are three of the four pillars displayed on the company’s website. The fourth is passion, which Gidley says is really focused on the needs of the patients.
“Each employee and each board member who is a part of Total IRB is completely focused on human research subject protection and improving the quality of clinical research,” she said.
Serving an Industry Need
“Although established officially this year, the vision for Total IRB started years ago,” Gidley said.
“I’ve always wanted to build an entire company that was totally focused on the protection of human subjects. Our official launch was at the Drug Information Association (DIA) annual meeting this year in San Diego. We had a fantastic response,” she said. “Many companies are looking to diversify the number of IRBs they use, particularly in light of a governmental sting operation that occurred this past spring, and they were very excited to see Total IRB as a new market entrant.”
“Our systems and processes allow us to continue to offer that same level of service to clients even as we grow,” Gidley said. Looking ahead, Total IRB is evaluating a need expressed by clients for a data safety monitoring board. “We are looking at offering that to our clients perhaps late next year.”
Wolfpack Football is Part of Her Work-Life Balance
“Starting a new company is an all-consuming process,” Gidley said, but she’s not complaining. In fact, she said, “It is difficult to ‘cut-off’ my work, as I enjoy it so thoroughly. Total IRB is constantly on my mind, even when not actively engaged. When you can be passionate about your work and career, it is that much more fulfilling. We are building a best in class IRB, so the confines of a typical work week do not apply.
“However, with that said, I do still manage to maintain balance between my career and my personal life. I have a young son and wonderful husband (J.D. Gidley) who both bring me such joy and fulfillment outside of work. Total IRB’s technology allows me to work efficiently from home, which I try to do a couple of days a week.” J.D. Gidley (B.S. Business Mangement, ’00) is a CERTIFIED FINANCIAL PLANNER ™ with Ameriprise Financial.
She also makes time for her alma mater. “NC State is part of my personal life as well. J.D. and I are huge NC State Football fans, so Saturdays are always reserved in the fall for Wolfpack football.”
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