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Compliance In Focus
Posted by Sandra Maddock on Tue, Oct 23, 2018

How To Ensure Compliance During Your Medical Device Trial

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In the daily chaos of running a medical device trial, it's a struggle to keep from dropping the baton. 

There are patients to enroll, protocols to follow, vendors and large volumes of data to manage. It’s enough to stress out even the most experienced clinical research professionals!

Take a deep breath. Remember all the work you’ve done to plan your trial before it started. Feel confident in your clinical research team, knowing they have been trained to understand and apply all the necessary regulations.

Then, follow these recommendations to keep your medical device trial running smoothly—and stay compliant.

Don’t Take Your Clinical Research Coordinators for Granted

Clinical research coordinators serve an important role in keeping your trial on track. They enroll patients, ensure your sites are following Good Clinical Practice (GCP) guidelines and enter data. If they are overwhelmed with too many tasks, there’s a good chance you’ll experience delays or find something has fallen through the cracks.

If your clinical research coordinators consistently have too much to do and too little time, consider outsourcing some of their work to a contract research organization (CRO). A CRO can help you enroll patients and assist with remote data entry, ensuring your trial stays on track.

Assign a Vendor Manager

Clinical trials involve a lot of moving parts and people. Aside from overseeing your own team, you will also need to oversee relationships with vendors. You may even need to conduct clinical vendor audits.

While it may be tempting to take this on yourself, it can bog down your workload and take your attention away from other pressing matters. To keep your trial moving, it’s best to assign a single point of contact. That could be one of your team members or a member of your CRO.

Hire a DSMB or a CEC

Depending on the complexity of your medical device trial, you may need oversight from a Data Safety Monitoring Board (DSMB) or Clinical Events Committee (CEC.)

While both are ultimately responsible for protecting your trial’s subjects, each has a slightly different focus. Here’s a quick overview of the difference between a DSMB and a CEC.

A DSMB:

  • Reviews cumulative study data
  • Looks at safety indicators primarily and may review effectiveness information to decide whether a study should continue
  • Is often recommended for clinical trials involving vulnerable populations

A CEC:

  • Reviews individual occurrences of specific endpoints and adverse events
  • Determines whether events were possibly connected to the clinical trial
  • Is often recommended for clinical trials with risks that could result from preexisting conditions

If you’re not sure whether to hire a DSMB, a CEC or both, this infographic can help.

Hiring either of these safety monitoring groups adds another layer of oversight to your trial. However, be aware that it takes time to assemble a truly objective board and manage the relationship with them. If your team hasn’t done this before or you don’t have the time, a CRO can take on this responsibility and serve as a liaison between you and the board.

Staying Focused on Compliance Throughout Your Clinical Trial

The clinical trial lifecycle is long, especially when you’re introducing a new medical device. There are specific regulations that make medical device trials even more complex than drug trials in some respects.

Proper planning and a well-trained team can go a long way to help you comply with these regulations, but ultimately, execution is what matters. Having the support of a compliance-minded CRO like IMARC can help you at every stage in your trial, whether you need ongoing support for day-to-day activities or just an occasional audit to spot-check your work. Here are just a few of the ways we support clinical research teams during a trial:

  • Conducting site initiation visits
  • Implementing risk-based monitoring plans
  • Assembling a DSMB or a CEC and managing the relationship
  • Remote research coordination
  • On-site support
  • Communicating with vendors
  • Conducting vendor audits

To learn more about how we can help you achieve compliance and reach the finish line faster, please contact us today.

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Stay tuned for the final post in this series, where we’ll focus on how to ensure compliance after your medical device trial.

Topics: Compliance

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