An Intern’s Glimpse into the World of a CRO

As a Master of Health Administration (MHA) candidate at the University of Miami and a Program Development intern at Biorasi for the last four months, I had the unique opportunity to take a dive into the exciting process of drug development while exploring the healthcare environment that these products are interacting with and eventually impacting. If there is one thing that stands out about both the healthcare system and the CRO world, it is that they are both multifaceted and intricate, often requiring a deep understanding of the stakeholders, processes and regulations and the interactions among them. Some of the most impactful takeaways that I will carry with me pertain to the people and technologies that propel these industries forward.

Collaboration is Key

A recurring theme that I saw at Biorasi was the need for collaboration and active participation in the multiple layers of clinical research. Many of the staff at Biorasi wear multiple hats, for example serving as members of the program development team and also engaging in project management activities while simultaneously investing time to improve quality and compliance on the regulatory side. This facilitates collaboration and sharing of ideas throughout the life of a project and allows individuals to follow their interests and skills to maximize value in clinical research.

Biorasi seems to set itself apart from other companies by engaging the talents of each of its employees rather than operating in silos according to employees’ job descriptions. This allowed me as an intern to explore my interests across the company and understand how the different parts function together.  As an intern in the program development team, I worked within the clinical, regulatory, data science, and project management areas of the company to learn how they all contribute to a successful trial. By employing such flexible and full-scope thinking, I learned to create proposals and conduct feasibilities for new projects. I was encouraged to think strategically about the full lifecycle of a program and develop solutions to consider the regulatory landscape, clinical execution, data reporting and evaluation mechanisms.

I first discovered just how accessible everyone at Biorasi is when I began reaching out across the different departments to get feedback for my capstone project. As a final culminating project of my MHA degree and internship, I was to develop an independent project to improve the company by applying the skills that I had gained as a graduate intern. To be quite honest, I had no idea where to begin. Leading any degree of organizational change requires full immersion in the company and its daily functions. And as a student who was two weeks into my internship, I felt that I was out of my depth. However, I was able to leverage the expertise of several of the department heads to gain a broader view of how each operated and understand the needs of the company. By listening to their feedback in an open and candid setting, I garnered insight into the operations of each department and how their collective contributions to the study success could be optimized.

Technology

Collaboration and cross-company communication must be facilitated by feedback loops and through simplified but functional technological systems and processes. Technology should be designed to work for us in making clinical trials more efficient. Health technology is a budding field with endless opportunities for optimization and end-user specialization. In the world of technology-enabled clinical trials, it is important to have flexible and purposeful technological systems in place that can be tailored to the needs of each trial and produce the most precise and timely results for the sponsor.

At Biorasi, we use the proprietary software system, TALOS™, to enhance clinical trial operations (). Following my meeting with the key department heads of Biorasi, I confidently decided to focus my project on improving TALOS™ to streamline work and create new feedback loops. I saw this as the perfect opportunity to improve an already high-functioning system and extend its ability to improve the day-to-day tasks of Biorasi employees. Additionally, I was able to create new reporting and evaluation mechanisms for utilizing past experience and assessment metrics to inform decision-making of the project teams as they plan new trials.

Conclusion

My time at Biorasi gave me great insight into the world of a CRO and showed me how a small- to- mid-sized player is making big waves in the industry as they redefine how clinical trials should be approached. This internship required me to learn quickly and adapt to the intricate world of pharmaceutical development. By utilizing both human and technological resources within the company and also conducting independent research to maximize my learning, I was able to considerably advance my personal understanding of the industry.