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Meet the Bioclinica eClinical Team: Amanda Nite, Senior Director of RTSM

Our flexible and innovative suite of eClinical solutions is supported by a team of people who have experience in all facets of clinical trials, which has been invaluable to our success. Therefore, we wanted to highlight a few valued contributors in this “Meet the Team” blog series.

For this entry, we spoke with Amanda Nite, our Senior Director of RTSM (Randomization and Trial Supply Management). In this role, she primarily focuses on Trident IRT (interactive response technology) as well as Bioclinica’s Agile approach to IRT, which promotes adaptive planning, evolving development and the use of fully functional study builds in vendor/client interactions rather than the development of specification documents prior to the study build. This approach makes the process more efficient and results in a higher-quality implementation.

We talked with Amanda about her current role, her experience in the clinical trial industry and her favorite part of her job. Read her responses below.

Q: How long have you been at Bioclinica?
A: I’ve been at Bioclinica for three and a half years. I was an Implementation Project Manager for over a year before moving into the leadership position for that group. I next moved over to become the Program Director of Embedded RTSM, where I developed Bioclinica’s IRT technology transfer program. Then I became the Director of Agile IRT, where I kept responsibility for managing the technology transfer program and developed our Agile IRT process. In September 2016, I became the Senior Director of RTSM.

Q: What is your role at Bioclinica?
A: As the Senior Director of RTSM, I am responsible for the leadership, structure and direction of the IRT operations team. I manage the IRT Plus Enablement program, which allows clients to build studies, and direct our team of solutions engineers who design studies and configure our system. I am heavily involved in determining the direction of the Trident product. I also spend time with our clients gathering feedback and working to continuously improve our processes and ensure satisfaction.

Q: How long have you been working in the clinical trials industry?
A: I have been working in the industry for ten years. My prior experience in the clinical trial space was at ICON, where I focused on IRT. I started off in validation there before moving into study design, managed my group in study design for a while and finally went into product design and standards design.

Q: How has your experience shaped the work you do today?
A: I’ve worked across a variety of the technical and project management roles common in IRT implementations. I believe that starting in validation has given me a significant advantage; I think it informs the way I look at our system and the issues that come up as well as my general approach to process development and problem resolution. Having varied experience has been helpful in my current role because I understand what is required from the different roles within the organization. Project management experience is helpful because it allows me to break down work and make sure projects stay on track.

Additionally, before I worked on clinical trials, I worked for pharmaceutical and biotechnology companies in more science-related roles doing manufacturing and process development. My experience in technical process development, which is very lab oriented, has been helpful as I worked out processes for Agile IRT because it gave me an understanding of how to develop and optimize processes.

Q: What experience does the Bioclinica IRT team bring to the table?
A: We have a breadth of experience in the IRT industry. Our team understands both the technical and clinical sides of IRT, which enables them to be a true partner to our clients. This partnership shows as we work through study design and provide feedback on what works well for sites and what functionality will be easy to use and fit well into our core product. It also shows during the study conduct phase, where our experienced team of RTSM Leads manages the day-to-day aspects of the study.

Q: What makes Bioclinica different from other companies with IRT solutions?
A: I think it is our consultative relationships with our clients. We have a technology solution that lends itself really well to working with a client to develop a system that meets their exact needs and provides a great site experience. By understanding both the technology and the clinical side of the industry, we can provide a solution that’s optimized for the particular protocol.

Q: What is your favorite part of your job?
A: I really like attending and speaking at conferences. I enjoy meeting other people in the industry and getting to talk about all the great things Bioclinica is doing.

Want to learn more about Trident IRT and our suite of eClinical solutions? Contact us!

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Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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