Clinical Team Lead
Clinical Team Lead
Shannon Kirby brings a wealth of cystic fibrosis (CF) and clinical research experience to the Rho team. With over 10 years of clinical research experience, including 8 years dedicated to CF, Ms. Kirby brings a strong portfolio of trial management, protocol development, and clinical site relationships. During her many years at the Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center (CFF TDN-CC), she drove the success of multiple studies not only with her extensive CF clinical research experience but through proactive project management, mentorship of CRAs, site relations, and innovative solution-finding.
Ms. Kirby has a particular knack for empowering and increasing her team’s ability to be independent and make decisions to bring efficiency to trial conduct while simultaneously personally building trusted relationships with the network-sites. In fact, many TDN sites had Shannon’s cell phone number readily available and without hesitation picked up the phone to call. This personal touch is what sets Shannon’s style apart and is a key asset to successful study execution.
Shannon’s knowledgeable and well-rounded CF clinical research skillset includes development of protocols, informed consent forms, study related documents and tools, site monitoring and training, and metrics and timeline management, to name a few. She has performed all types of monitoring visits, overseen and trained CRAs, and trained research site staff. Additionally, she has experience working with many common pulmonary function tests such as spirometry, home spirometry, and multiple breath washout as well as many other common CF standard of care tests and procedures.
Why Cystic Fibrosis?
“The CF community is unlike any other. The engagement of people with CF, their families and friends, the CF research community, CF sponsors and CROs all striving to improve the lives of those that live with CF is unparalleled and draws you in. I have been incredibly fortunate to be a part of this community.”
This is what drives Shannon:
“When I first started in clinical research, as a research coordinator, my interactions with the patients and their families quickly made me realize the importance of gaining patient trust when conducting research. It is through our important work and projects that we are making a difference in patient lives. The relationships that I have developed along the way, have made a huge impact on my life both professionally and personally.”
Content by Shannon Kirby
In the complicated world of outsourcing clinical trials, using RFPs to gather comparable bids from CROs can be incredibly challenging. The good news is, with a little planning and time, you can create RFPs that will reduce inconsistencies among bidders and ultimately help you identify the CRO that is truly the right partner for the job.
A very common yet very critical question for a 505(b)(2) development program is “What clinical studies are needed to support the marketing application?” The clinical program required is very dependent upon the specifics of the new drug product and indication, and the studies necessary to gain approval can range from a single bioequivalence study to a more comprehensive Phase 2 and Phase 3 clinical program.
There are a lot of resources on how to deal with slow enrolling studies, but what about challenges with studies that enroll very quickly? Enrollment can be very fast for post-operative acute pain studies which brings with it unique challenges in study execution.