I’m excited to introduce Olya Lebedyeva, a new addition to the Advisory5 team of advisors. Olya and I first met at the NC Biotech Venture Challenge, and I was immediately impressed by her extensive experience and passion for clinical trials. With over 15 years of experience, Olya has a wealth of knowledge in leading global multifunctional teams, overseeing vendor management, and ensuring the successful completion of clinical trials. Her journey from a nurse in Ukraine to a project lead at Thermo Fisher Scientific is both inspiring and informative. Here, she shares her insights into the world of clinical trials.
Insights from the Insider
1. What Are Clinical Trials?
Clinical trials are research studies performed on people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way researchers determine if a new treatment, like a new drug or diet or medical device (for example, a pacemaker), is safe and effective in people.
Olya explains, “Clinical trials are essentially a process of testing a drug that has been approved by the FDA for human trials. This can be in phases, from initial small-scale Phase 1 trials to large-scale Phase 3 trials. The purpose is to ensure the drug’s safety and efficacy before it can be marketed.”
2. What Should Startups Consider / Know About Clinical Trials?
For startups venturing into clinical trials, understanding the complexities and planning accordingly is crucial. Olya emphasizes the importance of having a clear vision and a well-defined budget. “Make sure you have a goal in mind and everything outlined. Do not make decisions midway, as this can skew your timelines and financial aspects,” she advises.
She also underscores the significance of selecting the right Clinical Research Organization (CRO). “The first thing startups should do is decide which CRO they will partner with. Your partners are more knowledgeable in the regulatory procedures, which is critical for the success of your trial.”
3. CROs and Their Role
A Clinical Research Organization (CRO) plays a pivotal role in the execution of clinical trials. They handle the logistics, regulatory compliance, and data management necessary for a successful trial. Olya highlights the differences between average and top-tier CROs. “There is a measurable difference in delivery and expertise. Larger CROs can provide a wider range of services in-house, which makes the process smoother.”
She adds, “When choosing a CRO, it’s essential to interview them, understand their capabilities, and see who you connect with. A good relationship with your CRO can significantly impact the trial’s success.”
4. Career in Clinical Trials
Olya’s Story
Olya’s journey into clinical trials is a testament to her resilience and dedication. Starting as a nurse in Ukraine, she moved to the United States and initially worked in a different industry. “I started working in transportation, completely removed from the medical field. Seven years ago, an opportunity arose to get back into the medical field, which I grabbed. I started from the very bottom as a clinical trial assistant,” she recalls.
Her Current Role
Now, as a Project Lead at Thermo Fisher Scientific, Olya manages the technical and operational aspects of clinical trials. She coordinates multifunctional teams, oversees vendor management, and ensures compliance with regulatory standards. “My role involves managing timelines, finances, and making sure that every aspect of the trial runs smoothly,” she explains.
Advice for People Considering This as a Career
For those considering a career in clinical trials, Olya offers valuable advice. “Go for it. If you have an opportunity, don’t hesitate. The impact of the work we do is incredibly rewarding. There are days when the work is tough, but knowing that the medication you’re helping to develop could change lives is worth it.”
She also stresses the importance of continuous learning. “You never stop learning in this field. There’s always something new to understand and improve upon. Whether it’s regulatory standards, medical writing, or data management, being open to learning is crucial.”
Conclusion
Olya Lebedyeva’s journey and insights provide a comprehensive look into the world of clinical trials. From understanding what clinical trials are to the challenges and rewards of managing them, her experiences offer valuable lessons for startups and individuals considering a career in this field. At Advisory5, we are thrilled to have her expertise and look forward to the positive impact she will have on startups in our program.
Inside Clinical Trials: An Insider’s Perspective