Establishing a Clinical Research Trials Site At Your Private Practice: A Step by Step Guide
- Nisha Mehta, MD
- 5 days ago
- 12 min read
Clinical research is an attractive ancillary service for many private practices who want to expand treatment options for patients, while also contributing to advancements in medicine, earning supplementary income, and establishing a new line of business for the practice. While a lot of clinical research is performed at academic institutions, there is a push to diversify the patient population in these studies, leading to increasing opportunities in the private practice space. Below, we cover a step-by-step guide on how to start a clinical research site to help physicians find opportunities and navigate the process as they look to build an additional income stream, especially for private practices.
We often 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, make sure you’ve signed up for our clinical research matching database (you must be a member of our free physician only Physician Side Gigs group to access, but it’s completely free to join). Regardless, make sure you sign up for our PSG weekly newsletter, where we publish current and upcoming opportunities.
Disclosure/Disclaimer: Our content is for generalized educational purposes. While we try to ensure it is accurate and updated, we cannot guarantee it. We are not formal financial, legal, or tax professionals and do not provide individualized advice specific to your situation. You should consult these as appropriate and/or do your own due diligence before making decisions based on this page. To learn more, visit our disclaimers and disclosures.
A step-by-step guide to get started with clinical research trials at your private practice
While we’ve briefly covered the options for clinical research opportunities for physicians, we wanted to dive deeper to help physicians understand each step of the process.
Getting involved in offering clinical research trials at a private practice involves seven phases, each with their own typical timeline and steps for implementation. These phases can overlap as you tackle different stages simultaneously to set up your clinical research trial site:
Phase 1: Assessment & planning (weeks 1 & 2)
Evaluate your practice’s readiness
Choose your desired involvement level
Phase 2: Education & certification (weeks 2-4)
Complete essential training
Build out your knowledge base
Phase 3: Infrastructure setup (weeks 3-6)
Prepare the physical space
Establish standard operating procedures (SOPs)
Build your research team
Phase 4: Regulatory & compliance setup (weeks 4-8)
Establish the regulatory framework
Set up technology and related systems
Phase 5: Finding trial opportunities (weeks 6-8)
Connect with potential opportunities
Evaluate potential trials
Phase 6: Prepare to launch your first trial (weeks 8-10)
Complete the site qualification process
Develop a patient recruitment strategy
Phase 7: Launch and maintain ongoing operations (week 10 & beyond)
Enroll your first patient to a trial
Keep up with ongoing operations management
We’re going to look at each step within these phases separately below, but when looking at the process chronologically, setting up a clinical research site and kicking off your first trial often takes at least ten weeks.
Step 1: Evaluate your practice’s readiness to establish a clinical research site
Before you start steps to establish a clinical research site, it’s important to assess if your practice and patients are a good fit for a site. You don’t want to spend a lot of time and energy preparing a location and establishing protocols if you won’t be able to get any trials for your patients.
To assess your practice’s readiness, you’ll want to:
Review your patient volume and demographics
Evaluate available space in your practice for research activities
Check whether your staff could realistically take on extra responsibilities
Determine time available for research activities
Review your financial capacity for the initial setup (this can often range anywhere from $12,000-$35,000 depending on your setup)
Specific questions to ask during this evaluation to help you gauge moving forward include:
Do you have patients who might benefit from clinical trials?
Can you dedicate space for secure storage and research activities?
Are you prepared for additional administrative responsibilities?
Do you have staff who could transition to research coordination?
Clinical research can be a great addition to a private practice, but you want to make sure it’s a good fit so that the benefits outweigh the opportunity and financial costs. While the initial financial investment above may come as a surprise, revenue from each enrolled patient can range between $15,000-$50,000, providing a potentially highly lucrative opportunity.
Be realistic in your assessment above, as the more critical you are here, the more potential road blocks you may be able to avoid along the way.
If you sign up for our clinical research matching database (physician only), we use your initial responses to help prescreen you to connect you with relevant matches that might be a good fit, based on your desired involvement level (which we cover next), location, environment, and other factors sponsors and site management organizations may look at.
Step 2: Choose your desired involvement level
There are a few different roles physicians can have in clinical research. Each role comes with its own set of responsibilities and benefits.
Become a principal investigator (PI): As a PI, you can lead your own trial site at your private practice. This role comes with more responsibilities, but is also likely to lead to a higher potential revenue in return. As a PI, you have full operational control (and responsibility) for a research site. This role is often better suited for physicians who already have clinical research experience.
Start as a sub-investigator (sub-I):Â As a sub-I, you work under the supervision of an experienced PI. This can allow physicians interested in getting involved with clinical research for the first time the ability to learn the ropes before leading their own trials. This also offers a lower initial commitment and risk, and requires minimal infrastructure to incorporate.
Take on a clinical research physician role: If your practice isn’t ready to establish a site, you can also work with established clinical research companies. This can minimize disruptions for your practice and open up roles for physicians who aren’t currently working in the private practice environment. These roles are employment-based rather than practice-based, with various specialized roles available, depending on the specific opportunity.
Our clinical research matching database matches physicians with opportunities for each of these roles.
Step 3: Complete essential training
There are a few essential training requirements for most clinical research roles.
Good Clinical Practices (GCP) training: This training is essential for conducting clinical research and is required by most sponsors. It covers ethical and scientific quality standards.
Collaborative Institutional Training Initiative (CITI) certification: This is a widely recognized certification that focuses on human subjects research training. This can often be required by the IRB (Institutional Review Board).
International Council for Harmonization (ICH) guidelines: This covers regulatory knowledge to help ensure clinical research is conducted ethically, safely, and with high scientific quality.
Step 4: Build your knowledge base
If you are new to clinical research and want to build up your knowledge with additional training and resources, options you can also consider include:
Clinical research workshops and webinars
Professional conferences
Online courses and publications
Networking with experienced researchers
Explore all our free PSG resources for clinical research. Make sure you sign up for our weekly newsletter for alerts about free webinars on clinical research and other topics.
Key study areas to focus on include:
Clinical trial phases and methodology
Informed consent processes
Data collection and documentation
Adverse event reporting
Regulatory compliance requirements
Patient safety protocols
Step 5: Prepare the physical space
Preparing physical space in your private practice is important for compliance, participant safety, and smooth study operations.
Space requirements to meet standards include:
A secured storage room with locking door for investigational product
Separate medication storage (trial drugs should be kept separate from practice medications)
Temperature-controlled storage (refrigerator/freezer as needed)
Secure document storage for research data and study supplies
You will also need to assess your equipment and perform maintenance as required to ensure all equipment meets manufacturer requirements.
To help meet space requirements, add these items to your clinical research preparation checklist:
Install appropriate locks and security measures
Set up temperature monitoring systems
Create organized storage systems
Ensure adequate lighting and ventilation
Plan for potential sponsor inspections
Step 6: Establish standard operating procedures (SOPs)
Establishing standard operating procedures (SOPs) provides clear and consistent guidelines for how research activities should be conducted at your practice. These can help meet Good Clinical Practice (GCP) guidelines.
SOPs you’ll want to have on hand for you, your research team, and for potential audits include:
Patient recruitment and screening
Informed consent process
Study visit procedures
Data collection and documentation
Adverse event reporting
Communication protocols
Quality assurance measures
Step 7: Build your research team
A strong clinical research team can help you conduct studies efficiently, ethically, and in compliance with regulations.
Your core team should include:
A study coordinator, who handles logistics, paperwork, and patient communication
A research assistant, who supports data collection and follow-up
Administrative support, who manage scheduling and documentation
Depending on their particular role and involvement, members of your research team will likely also require training. If you work with a company, depending on the model, they may be able to help provide these team members or help you get leads.
Your research team staff should:
Have training in GCP and research protocols
Understand regulatory requirements
Possess strong organizational and communication skills
Have the ability to maintain detailed documentation
Step 8: Establish the regulatory framework
As you get a team in place, you’ll also want to put together a framework for processes, documentation, and systems to ensure your studies comply with all relevant international, federal, and institutional regulations. This allows you to protect the participants and maintain the integrity of your study data.
Essential documents you’ll want to have include:
Clinical research agreements/contracts
Standard informed consent forms
Patient recruitment materials
Regulatory compliance documentation
IRB (Institutional Review Board) procedures
Along with the SOPs you develop for audit preparation and quality assurance, at this stage you’ll also want to develop out:
A document management system
Data security protocols
Step 9: Set up technology and related systems
While this step is optional, it’s good to have to help your site be as efficient as possible. You can manage all the data and documents on paper, but as with other medical records, this can be a very complex process to manage.
Technological systems that can help streamline your processes include:
An EMR with the ability to capture research data or electronic source system
Secure communication platforms
Document management software
Scheduling and patient tracking systems
Backup and data security measures
Step 10: Connect with potential opportunities
Once you have your staff, procedures, and systems in place, you’re ready to start looking for potential studies to conduct at your research site. There are a few avenues to connect with potential opportunities.
Network to find opportunities (and leverage the network you already have): To find clinical research opportunities, consider attending industry conferences and events, joining clinical research networks or professional associations, and/or connecting with site management organizations. As a reminder, you can leverage your Physician Side Gigs network and sign up for our free clinical research opportunities database (physicians only) for alerts about potential opportunities.
Reach out directly: Options for finding opportunities directly include contacting pharmaceutical companies and medical device manufacturers directly, connecting with Contract Research Organizations (CROs), or partnering with academic medical centers.
Sign up for online platforms: Online platforms, such as clinical trial databases and research matching platforms, exist where you can register and create profiles to find opportunities. Just be careful to vet every platform and every opportunity you come across, and be cautious of online sites that want to charge upfront fees to connect you. Our clinical research matching services for members looking to add clinical research to their practices are free to sign up for (to be alerted of potential opportunities matching their criteria).
Step 11: Evaluate potential trials
Once you’ve connected with opportunities, you’ll want to vet each carefully to ensure it’s a right fit for your practice and research site.
Key criteria to consider when assessing trials include:
Patient population match with your practice
Protocol complexity and requirements
Compensation structure
Timeline and duration
Required resources and staffing
Training and support provided by sponsor
Step 12: Complete the site qualification process
Sponsors (pharmaceutical companies, medical device manufacturers, CROs, etc.) will also want to evaluate your site as a fit for their trial by implementing a site qualification process. Sponsors use this process to help ensure the site has the staff, facilities, equipment, and systems (which you put into place above) to safely and effectively conduct the trial before allowing a site to participate in a study. They will also ensure the site will meet GCP and regulatory requirements.
During this process, sponsors typically require you to:
Complete site questionnaires
Provide facility information
Submit staff qualifications
Undergo site inspections
Demonstrate regulatory compliance
A pre-study, in-person site qualification visit is also usually required. During this process, the sponsor will inspect the facilities, review your procedures & documentation, and review staff training & protocols, which can help them with their final approval process.
Step 13: Develop a patient recruitment strategy
You’ve found a trial and have been approved by a sponsor. Congratulations! You’re now ready to begin recruiting patients for the study. Slow enrollment can delay a study, or even cause it to fail, so it’s important to have a strategy in place for patient outreach so you can kick things off quickly. Along with patient recruitment, also consider patient retention.
As part of your strategy:
Identify eligible patients from your practice
Develop screening procedures and protocols
Put together an informed consent process
Develop patient education materials
Have strategies for follow-ups to help retain patients
Step 14: Enroll your first patient to a trial
The first patient enrollment in a clinical trial is a major milestone, marking the transition from planning to study execution. You’ll want to carefully coordinate your patient enrollment processes to again ensure compliance and safety.
Key steps include:
Implementing your screening procedures
Conducting thorough informed consent process
Beginning data collection protocols
Establishing communication with sponsors
Monitoring for adverse events
Step 15: Keep up with ongoing operations management
As you enroll patients into your study and complete trials, you’ll need to manage and oversee the daily operations of your clinical research site.
Day-to-day management includes:
Patient visits and assessments
Data collection and entry
Protocol compliance monitoring
Communication with study teams
Documentation and record keeping
A key part of ongoing operations includes maintaining quality assurance for your research. Make sure as part of this process, you:
Conduct regular protocol compliance reviews
Perform staff training updates
Oversee and maintain document management
Prepare for a potential audit and are ready to respond to an audit request, when required
Tips to be successful in clinical research
Now that we’ve outlined the steps to get started with clinical research, we wanted to provide a few quick tips to help ensure success along the way. Clinical research is both a service to patients and medical advancement, as well as a potential business opportunity. Success requires balancing all three aspects effectively.
Start small. Begin with one trial to learn processes before scaling.
Invest in training. Proper education prevents costly mistakes.
Build strong teams. Success depends on dedicated, trained staff.
Focus on compliance. Regulatory adherence is non-negotiable.
Actively network. Relationships lead to better opportunities.
Plan for growth. Design systems that can scale with success.
Conclusion
We know this comprehensive guide is a lot of information and the amount that needs to be done may be overwhelming. Remember, you don’t have to do everything at once. It typically takes about 10 weeks to get up and running with your first clinical research trial, but you can create your own timeline. Following the phases and steps above can help provide the most efficient process to get started as efficiently as possible.
If you’re interested in the research side and income potential of clinical trials but are overwhelmed by the administrative burden that it takes to set up and manage a clinical research site, clinical research site management organizations often come to us looking for physicians interested in setting up clinical research sites at their practices. These companies offer support and opportunities that can seamlessly integrate into your practice and schedule, handling the coordination with sponsors, CROs, and regulatory agencies so you can focus on your patients.
Sign up for our clinical research matching database to be alerted of opportunities available.
Related resources for physicians
New to clinical research and interested in learning more? Explore our clinical research primer for physicians, that covers the benefits of clinical research, setting up a trial site, identifying trials, and more.
Physicians in private practice can also explore:
We offer a free private practice educational series for physicians interested in virtual events to help you start and manage your practice. Sign up for our PSG weekly newsletter for alerts on upcoming events and registration links.