By David Russell, CRCP—Director of Site Strategy, PFS Clinical
In my years working in the industry, I’ve learned firsthand that no two research organizations are alike. For that reason, it’s impossible to find a one-size-fits-all model for a centralized clinical trials office (CTO). I’ve had the opportunity to support many organizations as they’ve moved toward a centralized CTO, and it’s always clear that the success of the venture requires that you take the time to evaluate strengths and opportunities for growth before you create a plan. Over time, I’ve developed a few key questions that can help research institutions identify existing skills and any initial hurdles that might inform and impact CTO creation. If your organization is looking to establish a centralized CTO, finding answers to the following questions can help create a blueprint for a plan that will enhance your individual processes.
Here are five key questions every research organization should answer when considering moving toward a centralized CTO model:
1. How can our current established structure most optimally support and oversee our entire research operation?
This is what I refer to as a “ground zero" question—that is, it asks the organization to evaluate the processes it currently has in place. A thorough understanding and evaluation of current structure will provide a foundation for building an effective model for your institution.
2. Do we have the appropriate resources to ensure a competent and compliant research operation?
This is another ground zero question. Unlike the first question about structure, this question speaks to the current personnel working within the research enterprise. Who are the content experts on staff? Are there key leaders you can start with? Can you identify any “shining stars?” The answers to this question will help you identify areas where you might need a little more support, and will also help you recognize some potential key players in your transition to a centralized CTO.
3. How can we serve our research efforts in the most effective and efficient way?
Answers to this question provide a solid view of the current thoughts and values your organization places in its research program. This will help you focus your efforts on creating a model that aligns processes with values. A centralized CTO should be a supportive element of your research program, and that support should enhance administrative processes and extend to the big-picture needs and values of the organization.
4. Is technology properly supporting our clinical trial delivery?
The purpose of this question it to identify key areas that may need technological support. Important questions that fall under the umbrella of clinical trials technology include:
Do you currently use a CTMS? If so, how is it working?
Do you use an automated or manual process for identification of research subjects and assignment of the proper codes and modifiers required by CMS?
How are research revenue reports generated?
5. Are we continually looking for ways to improve our processes and performance?
The answers to this question help to identify and clarify your institution’s overall impression of its research program and processes therein. If you are even considering the move to a centralized CTO, there is some recognition that the current processes need attention. Creating a centralized CTO that pays attention to specific areas of potential risk on a consistent and ongoing basis can assure you are up to date with current regulations and requirements. Plus, it can really go a long way toward optimizing performance.
Next Steps and Finding Support
Before you begin making decisions, you’ll need to make sure your senior leaders are on board. As you work to achieve buy-in, it’s important to do your homework on why centralization will be a benefit to your specific institution. Data and real-life examples must be collected to demonstrate how forming a centralized department for research will reduce compliance risk and result in cost savings for the organization. In order to report an accurate account of current risk factors, you’ll want to perform an assessment in all key areas.
Along with acquiring good data, you must also consider how to best implement the new centralized model. This transition can either take place internally or with the help of an external partner. Engaging an external partner can be advantageous as they can oversee the process and can help bridge initial gaps to expedite the centralization. Furthermore, having an experienced, unbiased third party assess the institution’s research operation and produce a report can help give this process more credibility.
In the event that internal expertise is available, a partial partnership model can be achieved by working with an organization that has the background and personnel to help in overflow situations due to high volumes, competing priorities, or if specific unusual circumstances arise.
If your research institution is considering making the transition to a centralized CTO, remember: there’s no such thing as a universal model. Use these questions to begin to create a blueprint for centralization, and to help you identify any areas where you may need more support. Before you begin to paint a picture of what centralization of your research activities might look like, take the time to establish the requirements, values, strengths, and challenges of your specific research program and its processes.
If you have additional questions on this topic, or need additional information, please do not hesitate to reach out to me directly at email@example.com.