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Compliance In Focus
Posted by John Lehmann on Thu, May 20, 2021

Is Your CRO Too Limited In Scope?

 

We’ve talked about the challenges of working with large CROs, but it’s also possible for a contract research organization to be too small and limited in scope.

CRO

The fact is that CROs vary in the scope of services they provide. Some CROs are what we call niche CROs, which means they provide only specific services, such as clinical monitoring or data management.

You might initially think that’s all you need, but as you dive deeper into your clinical trial, you may realize you need support in other areas. By that time, it can be difficult to cut ties with your existing CRO or introduce another third-party provider.

The Issues With Limited Scope CROs

Bringing more providers into your trial to perform specific functions makes project management and day-to-day operations more complicated. You have to transfer data between multiple entities, increasing the risk of data loss, errors, and duplication. There's also the increased risk of conflicts between multiple CROs, who may have very different approaches. This can slow down your trial significantly.

Another issue is that one CRO may assist with part of the clinical trial lifecycle while another provider or your own team handles the rest. This can lead to inconsistent approaches, which can compromise compliance and patient protections your team has worked so hard to achieve.

A CRO may also have limited scope because they are newer and less experienced. Depending on your own experience levels, going with a newer CRO can appear to be a budget-friendly choice, but sometimes it can actually cost your team more in the long run. For instance, if one of your sites receives an FDA Warning Letter or a civil penalty for failing to comply with regulations, you may have to pay fines.

How To Find A Full-Service CRO

A full-service CRO will support you at every stage of your clinical and have the expertise to handle all your needs, even if you haven’t identified them yet.

That includes:

  • Monitoring your trial to ensure your sites and staff are following all protocol and regulations
  • Auditing your processes, documentation, and vendors to ensure you will pass regulatory inspections
  • Consulting to help you mitigate risks and address unexpected issues as they arise
  • Project management services to streamline communication between all parties, help you keep your trial on track, and avoid delays
  • Safety management, including recruiting and coordinating with DSMBs and CECs to monitor adverse events
  • Data management, including setting up your electronic data capture system and assisting with data locks
  • Site support, including site assessment, selection, and initiation
  • Training for your entire team in regulations and best practices, from new research associates to experienced professionals 

In addition to providing a full range of services, your CRO should also be a good fit for your company. They need to fit within your budget, work well with your team, and have the expertise to help you navigate emerging challenges.

Here are a few key questions you can ask as you evaluate CROs:

  1. What kind of studies do you have experience in? If you are trying to bring a medical device to market, it’s especially important to find a CRO with expertise that is specific to your field.
  2. How long have you been in business? If the CRO is newer, look into the experience of its team members. There's a big difference between a new CRO run by people who have worked in the industry for decades and a new one with a mostly inexperienced staff.
  3. Will the leadership team remain involved in our trial? At some CROs, it’s common for the executive team to participate in all the sales discussions and then pass off your project to less experienced team members. Look for assurance that the leadership team will have oversight and be accessible throughout the project.
  4. How is your team’s turnover? Turnover rates among monitors and other clinical research associates tend to be higher than in other industries. Look for a CRO with low turnover and a seamless transition process if a team member leaves unexpectedly.
  5. Do you have global partnerships? Many clinical trials require extensive knowledge of global regulations. A CRO with established global partnerships will be in a better position to navigate updates, such as the new EU Medical Device Regulation (MDR).
  6. How will you ensure we stay within our budget? Few things are more frustrating than a CRO that initially provides you with a low project quote, then bills you with constant change orders throughout the trial.

Your CRO should support you throughout the entire lifecycle of your clinical trial. You should start working with them before the study even starts and continue to do so through the follow-up and approval periods. They can help you develop a regulatory strategy that will support your trial and a risk-based approach to monitoring, for instance. If possible, talk to other clinical research companies who have used this particular CRO and ask about their experiences.

Many CROs are particularly poor about post-trial support. Make sure that they will handle your final audits, your data analysis, and stay with you through the inspections and regulatory conditions you need to navigate to get approval.

What If Your CRO Isn’t Giving You the Support You Need?

Changing CROs in the middle of a study obviously isn’t ideal, but if you are experiencing persistent problems, progress has stalled, or your site has experienced serious violations, you might need to enlist a “rescue CRO” for a clinical study cleanup.

Otherwise, the problems will only build, and your trial could experience months or even years of delay.

Obviously, it's best to avoid this situation by hiring the right CRO from the start.

As a full-service CRO with global partnerships and specific expertise in medical device trials, IMARC can support your clinical trial at every stage. To learn more about our expertise and how we work with your team, take a moment to download this short guide.

Working With IMARC, Your Partners in Compliance CTA

Topics: Choosing a CRO

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