Topography’s Safety Philosophy and Why It Matters

No matter how healthcare providers choose to approach clinical research within their practice, safety must always be top of mind. 

While physicians are masters at following standard of care protocols, clinical trial safety operates at another level, and even the most experienced practitioners may not have had exposure to the principles of safety in a research environment. 

I would love to share a little bit more about how the Clinical Operations team thinks of trial safety here at Topography Health. Some of what we do is of course standard operating procedure following regulations, such as making sure the team is trained on Good Clinical Practice. 

However, we’ve made the decision to go beyond the expected safety standard when thinking about how we operate.‍

Training

Clinical Operations training starts with Good Clinical Practice (GCP), generally on a three-year cycle. Beyond that, all team members, whether experienced or new to research, go through a robust onboarding developed and implemented by Topography. We’ve gotten incredible feedback from sites on our rigorous and comprehensive training, which we’re always optimizing to make even better. Standardized training leadership is lacking in the trials space, which is why we set an extremely high bar for our own team.‍

Oversight‍

Our management structure for clinical operations was purpose-built to provide multiple levels of oversight on protocol adherence. Let me share a bit more about what that looks like:

• Our Clinical Trial Lead, or CTL, is on site every day to support the practice’s primary investigator(s) and research coordinators. They are at the physician’s office to answer questions and provide day-to-day oversight of research operations
  
  
• Regional Site Managers remotely manage multiple sites and conduct routine reviews to ensure both subject safety and protocol adherence. In addition, they work diligently with sponsors to troubleshoot any challenges ensuring we are set up for success in meeting our sponsor-defined goals.
  ‍
• As Executive Director of Clinical Operations, I serve as an important third layer of site oversight, quality, and patient safety. You can read more about my background in clinical operations in my Q&A.
  

‍‍
Quality Assurance

‍Second eyes is a compliance and quality concept across many industries but often lacking at the site level in clinical trials. At Topo, we require second eyes on key elements of patient safety, for example, subject eligibility. We also double-check informed consent documents. That means at least two human sets of eyes have confirmed eligibility and consent before a patient is allowed to enter a trial. While this is certainly not standard in our industry, it is just one way Topography is raising the bar in clinical research to ensure the safety of our subjects.‍

Internal Audit

‍
‍Finally, most sites lack audit capabilities, largely because you don’t need them all the time. At Topo our internal audit team proactively audits all sites on a regular schedule, which is just another way we demonstrate our commitment to safety and ensure our sites are ready for formal external audits at all times.

‍

‍

I’m proud to be a part of a company that empowers physicians and their teams to bring clinical research to patients as part of the standard of care. The way we structure and run clinical operations is a big reason why physicians choose to work with Topography. Whether they are experienced at running trials, or are opening up their sites for research for the first time, details really matter. We bring a level of robust staffing, management and leadership that far surpasses industry standards to provide the strongest possible partnership. We sweat the small stuff so they don’t have to.

‍