Workforce turnover has always been a challenge for Clinical Research Organizations (CROs), but the problem has accelerated during the last decade.
A recent study, published by BDO, emphasizes this issue, noting that “turnover in CROs has hovered around 25% on average over the last five years, significantly higher than other industries.”
Turnover in the pharmaceutical and biotech industry is ubiquitous, but it’s particularly high within certain specialties. Take Clinical Research Associates (CRAs), for example. According to BDO’s report, “turnover levels for CRAs in the U.S. have been persistently high in recent years.”
Unfortunately, the lack of access to qualified CRAs presents various challenges for clinical trials. Without experienced CRAs on staff, it can be difficult to ensure data quality and adhere to project deadlines. Nonetheless, it remains the responsibility of the trial sponsor to ensure patient safety and maintain the integrity of the clinical research. One of the best ways to guarantee both of these vital components is through CRA oversight. A few years ago, many considered investing in CRA oversight a luxury, but nowadays, it’s increasingly becoming a necessity to prevent disruptions and stay on track.
Benefits of Providing Comprehensive CRA Oversight
The COVID-19 pandemic and its subsequent aftermath changed clinical trials as we knew them. Things will never be the same again.
Upsetting as that may be, expecting the unexpected is the future. Comprehensive CRA oversight provides an extra layer of protection and can help navigate the challenges that lie ahead.
Let’s take a closer look at some of the benefits:
1) CRA oversight provides continuity
CRO turnover doesn’t appear to be improving, but oversight CRAs make these changes less painful. Specifically, oversight CRAs:
- Can provide continuity until a permanent replacement is found
- Are familiar with the study they’re assigned to and have relationships with each trial site
- Provide training for new hires
- Support trial enrollment
Oversight CRAs can provide some or all of these services, depending on your research needs.
2) CRA oversight improves research quality
Ever heard of the Hawthorne Effect? It’s a phenomenon that causes people to change their behavior when they know they’re being watched. An oversight CRA brings a sense of urgency to your research in that it helps hold your team accountable.
As this article from CRA Resources notes –– CRA oversight is “an extremely proactive approach to managing the quality agreement you have with your CRO…and has been shown to make a HUGE difference to the outcome of” studies.
3) CRA oversight can help you avoid 483 findings
The FDA issues a Form 483 if an inspector finds violations of the Food Drug and Cosmetic (FD&C) Act and related Acts during a trial inspection.
That occurs when “any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”
With an oversight CRA on staff, your team has a second line of defense and is much less likely to make common mistakes.
4) CRA oversight is cost-effective
Finding and vetting your own CRAs is a time-consuming process –– and rightfully so. You want the best of the best. But if you’re on a deadline and need results, an oversight CRA can help you maximize quality without breaking the bank.
Utilizing an oversight CRA through a FSP or specialty provider involves a small investment, but the benefits far outweigh the cost in many instances. As the saying goes, “an ounce of prevention is worth a pound of cure.” With an oversight CRA at your side, you can improve data quality, prevent study delays, and keep sponsors happy.
Oversight CRAs can be contracted as needed through a specialty provider. With this approach, efficiency is optimized and there are no fixed costs to the sponsor.
5) CRA oversight –– there when you need it most
Craving some one-on-one attention? Oversight CRAs travel less than their monitoring counterparts so they can provide in-person trial site support. They’re available to answer questions about patient care, data collection, or other topics whenever they arise.
In summary, the benefits of utilizing oversight CRAs greatly exceed the costs. With high turnover throughout the industry, the extra layer of oversight has transitioned from a luxury to a necessity on all trials.