As you look ahead to an upcoming clinical trial or evaluate the progress of your current one, you might be wondering if it’s time to ask for help.
A contract research organization (CRO) can add tremendous value to your research by overseeing critical compliance elements, assisting with routine activities like data review and communicating with vendors to keep your trial on track.
Asking for help isn’t always easy, but it’s often necessary. Here’s a closer look at the role of a contract research organization and nine signs it’s time to hire one.
What Is A Contract Research Organization?
In short, a contract research organization is a company that supports clinical research by providing outsourced services, such as monitoring, auditing, training, safety management, data management and project management. A full-service contract research organization provides all these services and more. Its team can provide support throughout the entire clinical trial lifecycle or step in at critical stages, such as developing a regulatory strategy before the trial or assisting with monitoring the data during the trial. After the trial, a CRO can assist with final audits, as well as data lock and analysis.
When Should You Hire A Contract Research Organization?
1. You Have A High-Risk Trial
Every clinical trial comes with inherent risks, but some risks may be greater or more unique than your sites have experienced before. Perhaps you are conducting a trial on a vulnerable population, such as children or elderly patients, and you need to be sure you follow all protocols for seeking informed consent. Maybe you are conducting a medical device trial for the first time. A contract research organization brings a wide range of experience monitoring many types of trials. They can help you devise an appropriate strategy for risk-based monitoring.
2. You Have High Staff Turnover
High turnover is an unfortunate but common challenge in clinical research. Clinical research professionals come from a wide range of backgrounds, bringing different career aspirations with them. They may work long hours and travel frequently, which is not ideal for everyone. Adding to that is the fact that there is no formal training required by any regulatory body. A contract research organization can train your team in the fundamentals of clinical research, ensuring everyone understands the regulations and follows a consistent process to maintain compliance.
3. Your Trial Is Experiencing Delays
A backlog of data isn’t the only reason your trial might be delayed. Eighty percent of clinical trials experience delays of up to six months, which can cost thousands of dollars per day. Delays can occur for many reasons, from adverse events to a change in strategy. A contract research organization can help you get things back on track.
4. You Recently Received An FDA Warning Letter
The FDA regularly inspects clinical trial sites through its Bioresearch Monitoring (BIMO) program and issues warning letters for deficiencies or violations.
A few of the most common FDA warning letter violations in 2018 were:
- Failure to conduct the trial in accordance with the investigational plan or applicable regulations
- Failure to comply with the FDA 1572 requirements
- Failure to record adequate case history and subject records
A contract research organization can help your trial recover after a warning letter by helping you develop a compliance strategy and conducting audits to prepare your sites for a BIMO inspection.
5. You’ve Experienced Miscommunication Among Key Stakeholders
With any trial, there are many moving parts and people to manage. In addition to the core clinical research team, you also have to manage communications from the device manufacturer, trial participants, vendors and other important parties. Without a designated point of contact, this can quickly devolve into chaos. A CRO serves as a liaison between all parties involved, overseeing all communications and keeping them updated on important milestones.
6. You Need To Hire A Data Safety Monitoring Board Or Clinical Events Committee
A DSMB or CEC may be necessary in the case of a high-risk trial or other circumstances. Sometimes regulatory bodies will even require it. These boards and committees are made up of physicians with specialized training in their field and can be difficult to recruit and manage if you lack experience with them. A contract research organization can assist with every aspect of safety monitoring—from recruitment to communication— so you can focus on securing approval.
7. Your Trial Has Gone Over Budget
While you can’t put a price on innovation, you have a budget for a reason. Delays, new technology or additional resources can quickly topple that budget. A CRO who views your success as integral to theirs will respect your budget and keep a close eye on expenses so you don’t experience additional costs that could have been avoided.
8. Your Team Is Small Or Inexperienced
Having a small team isn’t necessarily a problem, but it can create inefficiencies and liabilities. A contract research organization not only helps lighten your load; it also ensures you are keeping up with the latest technologies and innovative strategies.
9. Your Research Coordinators Are Falling Behind On Data Entry
Does it feel like your teams always have a backlog of data that needs to be entered, no matter how hard your research coordinators work?
This is a sign they are stretched too thin. Today’s medical devices require a high volume of data to be approved, and, thanks to wearable devices, that data could be coming from many sources. While real-time data collection can offer many advantages, it also brings logistical challenges. Your team may need help keeping up with data entry and ensuring all data is reported consistently.
The Value Of The Right Size CRO
Once a sponsor realizes they need to hire a contract research organization, many will enlist the largest one they can afford or the one with the most widely known name.
While it is important to hire a CRO with a proven track record and a global footprint, you also need to consider whether they are the right size to fit your needs. In the past two decades, our team has worked with a number of organizations that came to us after experiencing challenges with larger CROs. They told us they had a hard time getting a response to their questions or concerns during the trial, or the process became overly complicated with bureaucratic “red tape.” In other instances, the CRO allowed the trial to substantially exceed their budget or they failed to manage critical compliance issues.
IMARC has the expertise and partnerships to handle even the largest trials, but our team will never make you feel like just a number. We take pride in our ability to manage compliance, stay on budget and stay agile. Want to learn more about what it’s like to work with us? Download this short guide.