To all of you Sponsors who have expressed the desire to conduct your studies independently, coupled with the concern that you can’t do it without a CRO…I am here to tell you that you can do it.
You can plan and execute your own studies independently.
As many Sponsors have experienced, making a decision to hire a CRO does not guarantee success. The reality is that you, as the Sponsor, will still be responsible for the CRO’s actions and results (success or failure) and you will therefore be left to deal with all financial consequences of a failed study. It is essential that you understand what options you have when it comes to the successful execution of your clinical research projects.
Knowing how to conduct a study without a CRO gives you options. This knowledge will also help you manage the CRO more effectively if you do decide to engage one.
Many Sponsors find that conducting their studies without a CRO enables them to exercise more quality control over their data, build stronger relationships with their investigative sites, and handle their clinical monitoring program in a more effective way; all while scaling down dependence on an outside party.
It can also save them money and minimize their risks…If done properly, that is.
Because conducting a study without a CRO partner can be easier said than done, I wanted to share some tips from some of our Sponsors who have figured out how to conduct a study without a CRO.
Assess your Internal Team Resources
While many organizations are eager to conduct their studies without the help of a CRO, they find it challenging because they lack the knowledge within their current resource pool. Or, they have the knowledge, but not the bandwidth.
So how have other Sponsors solved this problem? Typically, Sponsors will create a core Clinical Operations team and then supplement certain areas via consultants, vendors, or partners. A couple of simple examples:
- If the study is a small phase I or II, keeping the regulatory affairs role in-house may make sense. However, if the study is a very large, global phase III, engaging an international regulatory consultant who understands regulatory requirements across multiple countries would make sense.
- Many sponsors decide to maintain the management of clinical operations in-house (monitoring and management of the study), but outsource the data management to a CRO or third-party vendor.
- When planning and/or executing a study across the globe, consider using country-specific small to mid-sized CROs to provide your monitoring and regulatory resources. They will work as we do, providing the resources to work directly for you which will give you control (and save you the overhead) while still being able to navigate the monitoring and regulatory requirements of their countries.
- You can also consider pursuing a hybrid option such as keeping larger and later phase projects with the CROs while managing all-new, earlier phase projects in-house.
- Another option would be to fire the CRO in terms of clinical monitoring (thus hiring your monitors independently or through a firm like ours) but keep the CRO engaged for all of the other aspects, such as study design and startup, data management, and regulatory affairs.
Assess your Technology Systems
Tracking your own data…well, that is the point, isn’t it? Using tools like an electronic data capture (EDC) system, electronic Trial Master File (TMF) systems, and document repositories will streamline the data tracking process. Still, they can be quite an investment for sponsors.
I have worked with sponsors who have the resources and/or knowledge within their existing resource pool to conduct a study without a CRO, but they haven’t invested in technology platforms.
While we are still working with Sponsors who are conducting paper studies, the investment into technology platforms is critical for long-term success. And while this investment can be significant; we have seen various EDC and eTMF companies offer reduced rates due to the travel restrictions and industry challenges caused by the COVID pandemic. With that being said, there is never a better time than now to take advantage of our current ‘travel restricted’ climate when it comes to exploring technology systems.
A warning for those of you who have been using a CRO and are considering breaking away from that partnership: If the CRO you have been using has the study data from your previous trials in their data systems, the CRO may not be legally required to give up that data. Or, if they are required to hand over your data, you still may have to fight for it. Additionally, you will have to transfer the data into your system, which will include not only the investment in the technology needed to house the data but also the cost of the actual transfer.
Assess your Ability to Engage Sites
One of the ‘selling features’ many CROs have in their arsenal is that they have a network of sites they can engage for your studies. When you decide to conduct a study without a CRO, you need to know how to select and engage your own sites.
Outside of site identification (consideration of patient population, key opinion leaders, etc), the process to activate the sites is complex, including tasks such as negotiating contracts and budgets, gaining IRB approval, ensuring essential documents are collected and stored, technology has been established at the site, site resources have been trained, pre-enrollment regulations such as informed consents and financial disclosures have been completed, etc. While performing these tasks is possible, it is essential to consider whether you and your team can handle the workload.
Assess your Ability to Write SOPs, Monitoring Plans, Investigator Brochures, etc
CROs are good at this…they use ‘tried and true’ monitoring plans and SOPs. From standard operating procedures to monitoring plans to investigator brochures, these documents are critical for governing the execution of your study. Therefore, regulatory and clinical documents should be concise, balanced, non-promotional, and will take significant time to create. If you are going to conduct a study without a CRO, you must either know how to write your plans, procedures, and investigational materials yourself or know where to find someone to help (hint, we do that).
Onboard your own Clinical Research Associates
The last topic to address, and one we feel is the most important when conducting a study without engaging a CRO, is to onboard your own CRAs. The Clinical Research Associate and Site Manager role(s) is, in our opinion, one of the most essential roles of the trial.
The CRA can make or break your study. This is the one role that ensures the human participants are safe; the reported data is accurate, complete, and verifiable; and the study is conducted according to the Sponsor’s protocol as well as the appropriate regulatory bodies.
Everything related to the study culminates with the effectiveness of the CRA. Since it is such a critically important role, why wouldn’t you want to select your own CRAs? If using a CRO, you often aren’t able to handpick your CRAs, and we feel that is one of the reasons why the attrition level of CRAs hired through a CRO is so high.
Now that you have Learned How to Conduct a Study without a CRO…Do it Seamlessly with craresources
While a CRO can help streamline the clinical trial process by handling anything and everything related to planning and executing your study, learning how to conduct a study without a CRO can help you cultivate a more hands-on relationship with your research. As a leading Clinical Research Associate (CRA) Recruitment Agency, craresources is dedicated to providing Clinical Research Associates and Site Managers to those Sponsors who elect not to use a CRO. To learn how to conduct a study without a CRO, reach out to our expert team to connect with contract and permanent Clinical Research Associates and/or Site Managers.