The benefits of having a research program within your organization are both direct and indirect. The obvious direct benefit is the financial value created by providing a revenue stream, attracting new patients, and increasing ancillary services. Indirectly, having a research program not only enhances the site’s visibility but also increases market share and improves community health. But none of this matters if you don’t include a focus on structure and staffing in your business model.
There are several foundational components, both organizational and structural, of a research program
Key organizational components:
- Leadership support
- Patient specialty mix and volume
- Physician interest and participation.
Key structural components:
- Solid pipeline of trials
- Aggressive budget negotiations and subsequent financial management
- Operational compliance
- Research informatics that handles various administrative duties required to open and track a research study.
Determining Your Structure
As you begin to develop your research program, you will need to determine what structure type best fits your organization. Remember to keep the goals of the structure at the forefront. How are the operations going to be governed? Be sure to develop your structure around the job functions, rather than the individuals currently doing those jobs, and make sure to have a succession plan built into that structure. A director position is key and should focus on business development and act as a key influencer within the operation. Selecting and empowering staff experts is important for establishing an effective structure. By having staff who are experts in their areas of focus, you ensure efficiency, effectiveness, and compliance. Lastly, make sure to have a well-documented policy and SOP. This is the best way to ensure best practices are being followed and it will keep your structure cost-effective.
An Important Staffing Role
A focus on administrative and clinical staff is important to the optimization process. The administrative staff will take care of program management, financial analysis, and regulatory concerns. Clinical positions should focus on taking care of their patients and placing them in trials, increasing the revenue for conducting the trial.
Avoiding Mistakes Through Compliance
Once you’ve determined what structure type best suits your organization, you must take compliance into consideration. An organization’s work and reputation can be at risk if units are not operating optimally and are experiencing compliance issues. In addition, you will want to make sure the structure is flexible so it can change with the changing needs of the organization rapidly. You’ll want to avoid conflict of interest reporting by keeping your governance, particularly IRB and compliance, separate from day-to-day operations for the clinical trial. Make sure to keep work manageable and maintain checks and balances.
After determining the structure and organizational types, and the staff is in place, you are ready to put forward a robust, compliant research effort and publicize to keep your work visible. You need to market your services and constantly remind physicians you are there to help them. Make sure leadership knows the value your research program is adding to the organization. A good clinical trial management software can help show leadership the impact research can have on an organization.
To get more in-depth detail on the structural types of organizations and how each can function, check out our free webinar and learn how a CTMS can help your site achieve optimization and maintain compliance, request a free demo of Clinical Conductor today.