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Compliance In Focus
Posted by Sandra Maddock on Tue, Apr 20, 2021

How IMARC Supports Your Trial In The New Hybrid Era

Although the new hybrid approach to clinical research presents many opportunities to reduce costs and improve collaboration, it also brings additional challenges, as our latest infographic shows.  

hybrid-clinical-research

Preparing for remote activities often requires more time and effort, and it’s not always more cost-effective. If you’re relaunching studies that had been on hold, your team may need to employ some creative thinking to ensure an appropriate strategy that continues to result in protected patients, data integrity, and overall compliance at every phase of your study.  

As a full-service medical device contract research organization (CRO), IMARC is uniquely equipped to support your clinical trial at every stage in the process.

Here’s a closer look at how our team works with yours.

Before Your Trial Begins

Protocol development

Your clinical trial protocols provide a framework for every activity you will undertake and how you will conduct it to ensure compliance.

It’s essential to get this right the first time because auditors will refer back to your trial’s protocol to determine how well you adhered to them later.

At a time when you are likely conducting some activities remotely and some in person, you will need to justify your reasoning if you decide to change your approach. You may also need to provide additional documentation if you were unable to perform certain activities in person, according to the FDA’s guidance for conducting clinical research during a pandemic.

Our team can review existing protocols and provide recommendations, especially if you are shifting your approach from on-site to remote activities or vice versa. We will consider your trial’s unique risks as we help you determine how frequently you need to conduct monitoring visits, which ones should be in person, and what type of follow-up is required.

hybrid clinical monitoring

Training

The FDA requires that investigators involved in the clinical research process be qualified by training and experience, but there are no standard clinical research training requirements specified by law. That means that each clinical research team may have different degrees of knowledge and experience.

You may have also experienced turnover among monitors and other clinical research associates in the past year.

IMARC’s comprehensive clinical research training helps you establish a standardized process for onboarding new team members and bringing seasoned professionals up to speed with the latest requirements.

We offer online courses your clinical research associates can take according to their role, as well as individual classes in specific topics like critical thinking, site management, and FDA inspectional findings.

During Your Trial

Clinical monitoring

Monitoring is an essential part of ensuring compliance. Unfortunately, good monitors can be hard to find — and even harder to keep.

Our team has over 20 years of monitoring experience and a well-trained team that can provide you with consistent, quality monitoring services. We can help you establish a risk-based monitoring approach that makes the most sense for your trial, given the complexities of your device and the profile of your patients. Then our team can conduct all monitoring activities from there or assist your team as needed.

We also have many years of experience in remote monitoring, including using secure file-sharing and access to electronic medical records, which can help you adapt quickly to new ways of working.

Learn more about our approach to remote monitoring in this video.

Project management

Like monitors, exceptional project managers can also be hard to find and hard to keep.

IMARC’s project managers serve as a single point of contact for everyone involved in your trial. They will establish a project schedule with key milestones and communicate with all parties to ensure you are meeting deadlines.  

Safety management

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 these safety monitoring groups add another layer of oversight to your trial, it takes time to assemble them and maintain communications with members. If your team hasn’t done this before or you don’t have the time, IMARC can take on this responsibility and serve as a liaison between you and the board.

We will work closely with your data management team to ensure everyone has access to the right data when they need it.

Learn more about how to improve communication between data and safety managers. 

After Your Trial

Auditing

One of the final steps in your clinical trial is the FDA’s review of your trial master file, or TMF. Inspectors will review the documents in this file to determine how closely your trial followed your study plan. They will look for any gaps in the data, any missing signatures, adverse events and anything that could compromise the integrity of your study.

Given the significance of a trial master file review, it’s becoming more common for sponsors to request an independent auditor to review their TMF before the FDA does.

IMARC can conduct trial master file reviews in person or remotely, which can reduce your costs by as much as half.

We can also conduct other audits to ensure your team is on track to pass all relevant inspections, including BIMO FDA inspections, vendor audits, and more.

If your teams are new to auditing and want someone to walk them through the entire process, on-site audits may be a better fit. For more experienced teams looking for a more convenient, cost-effective approach to auditing, we offer remote audits.

Additionally, if one of your sites receives a Form 483 or an FDA warning letter, we can help you draft your response and develop corrective actions to prevent it from happening again.

Data Management

As teams prepare to comply with new post-market surveillance requirements, data management is becoming an even more critical part of the process.  

Our team can help you choose the right electronic data capture system, build your database, conduct data analysis, and more.  We can assist with data entry and data review throughout the trial and conduct the final database lock when it’s finished.

No matter where you are in your medical device trial or where you’re conducting your research, our team offers exceptional support every step of the way.

To learn more about how we can help, request a consultation today.

Monitoring Services Consult - V2

Topics: COVID-19

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