You already know monitoring is a critical part of protecting patients, ensuring compliance and maintaining data integrity in clinical research.
What you may not know is where to find well-trained monitors. Although the Code of Federal Regulations (21 CFR 812.43) states that monitors should be qualified by training and experience, it does not require any formal training.
Additionally, high turnover is common in the monitoring industry because of high expectations and a steep learning curve that often outpaces a monitor’s pay.
Working with a contract research organization (CRO) for monitoring can help you avoid many of the challenges related to hiring and retaining monitors.
5 Reasons To Hire A Monitoring CRO
1. Objective Oversight
You’ve been so involved in planning your clinical trial that you can probably recite study protocol in your sleep. But sometimes when you’re so close to something, you can overlook the obvious. Hiring a monitoring CRO offers the advantage of having an objective third party to review your standard operating procedures and data. An experienced monitor will be well-versed in clinical trial regulations and able to identify any potential violations that could lead to FDA warning letters.
They are also more likely to spot errors in your data than someone on your own team who has looked at the same report several times.
2. A Consistent Approach
Monitors who work for a well-established CRO may be more likely to receive some form of training, which can put them at an advantage over independent monitors you might hire to be part of your team.
At a minimum, training for monitors should include:
- An overview of FDA regulatory requirements
- The fundamentals of Good Clinical Practice (GCP)
- Understanding a risk-based monitoring plan
- How to conduct various types of site visits
- How to protect human subjects
- How to obtain informed consent
- How to review essential documents
- How to verify source data
Be sure to ask about the training process as you research CROs.
3. Specific Expertise
While every monitor should have some foundational training, there are key differences in monitoring trials for drugs versus devices. Every study brings a distinct set of risks and challenges. Ideally, you want to work with monitors who have some expertise in the area of your research, whether it’s orthopaedics, cardiology, neurology, in vitro diagnostics or women’s health.
Hiring a monitoring CRO with expertise in medical device trials prepares you to answer the inevitable questions that will arise in your field, no matter what they are.
If you hire one monitor and they are unavailable for an extended period of time, you will likely need to hire someone at least temporarily to take their place. When you work with a monitoring CRO, you have an entire team to support you.
If one monitor is away, they can have their colleague fill in with on-site monitoring or remote monitoring. And if they come across a question they can’t answer on their own, they know where to go to get help.
5. A Full Range Of Services
You may think you just need a monitoring CRO, but as you go deeper into your trial, your needs might change.
For instance, you may need help preparing for a BIMO inspection.
You may need someone to manage scheduling and vendor communications to keep your trial moving forward.
Your research coordinators may also need additional help with patient enrollment, data entry or other responsibilities.
The right CRO can assist you at every stage in the clinical trial lifecycle, from planning to study closeout.
Why Hire IMARC For Clinical Monitoring?
Monitoring has been at the core of IMARC’s mission since it was founded over 20 years ago. We take great pride in the fact that not a single one of our sites have received a warning letter in that time.
As a global medical device CRO, our monitors come from a variety of backgrounds and have expertise in many areas. They receive extensive training in clinical research regulations as well as our proprietary FAIR Shake™ technique, which helps them address issues where the answers aren’t always obvious.
We can support your team with monitoring, auditing, training, project management, data management and more.
To learn more about our monitoring services and what it’s like to work with us, request a free consultation today.