Detailed Logistics of Setting Up a Clinical Research Trials Site
- Nisha Mehta, MD
- Jan 12
- 7 min read
Clinical research can be a great way to both add an additional revenue stream to your private practice and help advancements in medicine, all while providing additional options to your patients. While clinical research has a lot of advantages, it can take a while to get set up and run, and it’s important to assess if clinical research is right for your private practice before doing so. We’ve provided an overview of how to establish a clinical research trials site at your medical practice, but wanted to dive deeper into the real logistics of what adding clinical research trials to your practice looks like. Below, we walk through what it takes to start up a research site and run a trial and, specifically, the resources required.
We work with companies that want to connect with physicians interested in getting involved with clinical research. These companies can help you establish a clinical trials site at your practice and aid with many of the logistics covered below. If you would like to be alerted of clinical research opportunities matching your interests, sign up for our clinical research matching database (you must be a member of our physician only Physician Side Gigs group to access, but it’s completely free to join). You can also sign up for our PSG weekly newsletter, where we publish current and upcoming opportunities.
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The space required to add clinical research trials to your private practice
If you’re thinking of running clinical trials, you’ll need somewhere to store investigational drugs, and it can't just be your regular medication cabinet.
Sponsors require a locked, secure room. If your study involves drugs that need refrigeration, you'll need a dedicated fridge (with temperature monitoring, because they will check).
This doesn’t mean you need to build new space or move your practice. Many practices convert an existing room or even a large closet. The key is making sure it's secure, climate-appropriate, and separate from your regular practice operations.
Have staff ready to handle clinical research trial patients
Running trials solo is technically possible but practically a headache. At a minimum, you should consider having a study coordinator. An ideal study coordinator is someone who lives and breathes the protocol, manages paperwork, communicates with sponsors, and keeps everything organized.
Partnering with a site management organization (SMO) can help with staffing. SMOs often provide trained research coordinators and support staff, either on-site at your practice or remotely. This removes the need to recruit, hire, train, and manage research staff yourself. In addition, staff supplied by an SMO are often experienced professionals who already know the ins and outs of research. And if someone leaves, the SMO will replace them, so you don’t have to scramble to cover during leave or deal with turnover.
Related PSG resource:
If you’re interested in working with an SMO, sign up for our free clinical research matching database (physician only).
Think of your coordinator as the project manager for each trial. While you focus on the medical aspects and patient care, they can handle scheduling, regulatory documents, data entry, and the million little details that keep a study compliant.
As you add more studies, you may need to scale your research staff accordingly. As a reference point, you may be able to expect a study coordinator to handle 2-3 active trials, depending on the studies’ complexities.
Technology needed to run successful clinical research trials
You'll need systems for managing data securely, tracking patient visits, and documenting everything (and this truly means everything; clinical trials generate a ton of paperwork). Many practices use electronic data capture systems provided by sponsors, but you'll want your own practice management approach too.
Set aside a budget for:
Software
Secure data storage
(Some potential) hardware upgrades
None of these are crazy expensive, but they aren't free either. We looked at cost considerations for clinical research, and technology and software often runs in the $10,000 - $30,000 range.
If you’re looking to minimize your startup costs, working with an SMO can help, as they typically provide enterprise-level technology systems that you can access, allowing you to leverage their infrastructure without capital investment or IT headaches.
Related PSG resource:
If you’re interested in working with an SMO, sign up for our free clinical research matching database (physician only).
Time needed to set up a clinical research site & run trials
Time is the resource nobody talks about enough. It takes time to get the infrastructure in place and trials set up before you see your first patient.
There are several steps to establishing a clinical research trials site.
Again, an SMO can help fast track much of the startup process and handle the bulk of administrative work, which reduces the time you personally need to spend on the process.
When starting a new trial, plan for six to twelve weeks from "we want to do this study" to enrolling your first patient if you’re working with an SMO. (The process can take longer if working alone, and you’re not as familiar with navigating regulations, etc.)
There’s also the time investment to run the trials themselves. Your ongoing time commitment varies wildly by trial type. Some studies need weekly visits for months. Others are less intensive. As the PI, you might spend anywhere from five to twenty hours per week on research activities once things are rolling – more at the beginning, potentially less once your team gets efficient.
The workflow integration challenge of adding clinical research to your medical practice
This is where many practices stumble. You can't just drop clinical research onto your existing schedule and hope it works. You need to think through how research patients flow through your practice differently from regular patients.
Related PSG resource:
Some practices dedicate certain days or time blocks to research visits. Others integrate them throughout the week. There's no one right answer, but you need a plan before your first patient shows up.
Many SMOs provide workflow consultants who spend time at your practice helping you design systems that make sense for your specific situation.
The regulatory and compliance burden
Regulatory compliance in clinical research can be intense. You need to:
Maintain regulatory binders
Prepare for audits
Stay current with changing regulations
Manage Institutional Review Board (IRB) communications
Document everything meticulously
For a busy private practice physician, this administrative weight can be overwhelming, though an SMO can help with the regulatory burden. They have dedicated regulatory specialists who help handle:
IRB submissions and ongoing communications
Regulatory document management
Audit preparation and management
FDA inspection readiness
Protocol deviation management
Safety reporting requirements
Related PSG resource:
If you’re interested in working with an SMO, sign up for our free clinical research matching database (physician only).
Financial and contract complexities in clinical research
Negotiating contracts with sponsors, managing budgets, tracking payments, and handling invoicing for research activities all add another layer of complexity that many physicians underestimate. Your team (or your SMO’s support team) will need to understand:
Fair market rates
Budget templates
Financial reporting
Cash flow management
While setting up clinical research trials by yourself can have a higher income potential on the surface, as you’ll receive 100% of the rates you negotiate, an SMO may be able to negotiate better terms than an individual practice (increasing the gross revenue), can help manage the financial aspects of running trials, and may be able to offer financial guarantees or upfront payments to help improve cash flow.
Conclusion
Make no mistake, there are several hoops to jump through to get started with clinical research within your practice, but it can be well worth it. Not only are you providing your patients with an additional level of care and service and contributing to the greater scientific community, but clinical research can be quite lucrative as an ancillary income stream for your practice.
Successful practices don't just add clinical research, they build systems around it. This can be done with a dedicated, trained in-house team, or by partnering with an SMO, a research site network, or through another collaborative model. Working individually may offer a higher earning potential, but it comes with a trade off of time and resources. Trying to do everything yourself from day one is a harder approach (though doable), especially if you’re newer to clinical research and haven’t set up or operate a site before.
Regardless of the model you pursue, start with one trial before scaling up. Once you understand the workflow and see the benefits, you can decide if you want to expand and/or want to bring more operations in-house.
Additional clinical research resources for physicians
Related PSG resources:
You can also explore other ancillary revenue streams for private practices.
Sign up for our weekly newsletter for alerts of upcoming clinical research opportunities and free webinars on clinical research topics.