In the rapidly evolving landscape of clinical trials, effective management of biospecimens is crucial for the success of research initiatives. To navigate these complexities, Slope has appointed Brian Smith as its new VP of Product, bringing a wealth of experience from his diverse background as a vendor in clinical research and product management. With a career spanning project management, product management, clinical operations, and data management across various lab and clinical technology vendors, Brian offers a unique perspective on the various challenges and opportunities that inform today’s clinical trials.
In this Q&A, Brian shares insights into how his industry experience informs his current role at Slope, highlights key trends in biospecimen management, and discusses the transformative impact of emerging technologies like AI on clinical trials. He also outlines the strategic initiatives his team is working on to enhance Slope's offerings and support the evolving needs of study stakeholders.
Tell us a little bit about your background in supporting clinical trials.
I started my career in clinical research at Wyeth (which was eventually acquired by Pfizer), where I worked in the lab supporting clinical research on prominent vaccines like Prevnar. After Wyeth, I joined ACM’s central lab, helping to standardize global lab operations across Europe and Asia. This role involved navigating the complexities of international sample shipping and regulatory compliance.
Next, I moved to a small startup called iCardiac Technologies, focusing on ECG analysis in early-phase clinical trials. I built and led a project management team, eventually becoming VP of Operations. We developed innovative solutions like an eCOA platform, which was quickly adopted by major companies. After iCardiac was acquired by ERT (now Clario), I led product management for cardiac safety and later became VP of Data Management.
I then joined Science 37, where I led data management and clinical operations for decentralized trials. This role gave me valuable insights into site operations and the challenges of virtualizing trials. Now, as VP of Product at Slope, I oversee product development, data management, and customer success.
How has your industry experience informed your ability to navigate your current role at Slope?
My diverse background as a vendor across various therapeutic areas and clinical trial phases has given me a deep understanding of the challenges faced by sponsors, sites, and labs, as well as the complexities of today’s trials. This experience allows me to guide Slope's product development to support a wide range of clinical trials, from oncology to vaccines, and adapt to different trial models. Having worked with various shippers and in global regions, I understand the logistical challenges, such as exporting samples from regions like Latin America.
On the data management side, my experience with central labs and data collection helps me appreciate the importance of flexible data transfers and agile methodologies. This enables Slope to quickly provide clients with the data they need while developing scalable solutions for their evolving needs. By standardizing data formats, we can efficiently map data to any client system, ensuring adaptability to their unique requirements.
What are some of the most significant trends you see impacting biospecimen management?
One of the biggest trends in biospecimen management is the increasing complexity of sample processing, including in key therapeutic areas like oncology and rare disease. At Science 37, we ran fully decentralized trials where patients were often hard to find, making biospecimen logistics even more challenging. Processing samples in patients’ homes took up to two hours, and despite extensive training, errors in sample processing and shipping still occurred. As trials expand across more diverse sites, managing lab processing and shipping efficiently has become even harder.
Another trend is the shift toward adaptive trial designs, where sponsors aim to maximize insights from fewer patients. This often requires using multiple vendors for specialized sample processing, adding further complexity. However, many sponsors and CROs still struggle with visibility — often unsure of where their samples are or whether they’ve reached the correct lab for testing.
This is where Slope plays a critical role. Our platform helps sites manage storage, shipping, and processing with greater efficiency, reducing errors and delays. What’s more, we also provide real-time tracking and oversight, ensuring sponsors always know where their samples are and that they’re handled correctly. As trials grow more complex, having this level of control is becoming essential.
How do you think AI and other emerging technologies will change the landscape of clinical trials and biospecimen management?
Emerging technologies, especially AI, will transform clinical trials and biospecimen management by bringing intelligence to processes that have long been inefficient. Take kit inventory, for example—traditionally, sites receive kits based on fixed triggers, often leading to waste or shortages. AI-powered predictive analytics can change this by considering factors like patient enrollment rates, site location, disease prevalence, and shipping costs. This ensures sites receive the right number of kits at the right time, reducing waste while preventing shortages.
Beyond inventory, AI can help sites manage complex protocols by extracting and segmenting key information from lab manuals and protocols, enabling a more streamlined, scalable approach to sample collection. Instead of manually navigating hundreds of study-specific protocols, AI could allow sites to self-serve and standardize processes across studies.
AI-driven insights will also enhance trial execution by identifying trends in site performance, shipping logistics, and quality issues. For instance, analyzing historical shipping data could help prevent delays due to weather or regional disruptions. By leveraging AI in the future, the hope is we can provide sponsors and sites with proactive recommendations, helping them make informed decisions that improve efficiency, reduce costs, and ultimately drive better trial outcomes.
What strategic initiatives are your teams currently working on?
Our primary focus is on bringing even more value to our software users by continuing to enhance our interface. We continue to engage with many of the over 1,800 sites that work with Slope to understand their evolving needs, which we are using to develop a more seamless sample management experience that improves the user journey and expands our data collection capabilities. We're also empowering sponsors to configure the amount of data they need, providing them with deeper insights.
Our goal is to provide a single tool for sites to manage all of their sample-related trial needs. As we grow and expand our modules, our insights dashboard will offer more comprehensive data for sponsors, ensuring continuous access to incredibly valuable information.
As trials continue to grow in complexity, the need for more innovative approaches to biospecimen management becomes increasingly critical. Brian's insights highlight the importance of adapting to emerging trends and widespread sample-related challenges — especially in light of new ICH E6(R3) requirements that directly implicate traditional approaches to sample management.
That’s why Slope’s Biospecimen360™ software streamlines sample management across the entire biospecimen lifecycle — from lab kit to final destination — reducing errors and offering real-time visibility to the entire process. To learn more about how Slope can support your study needs, check out our resources or request a demo.