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Compliance In Focus
Posted by John Lehmann on Thu, Jun 3, 2021

5 Frequently Asked Questions About Working With IMARC

 

Trusting a CRO to manage your clinical trial can feel a bit like asking someone new to care for your baby.

IMARC-FAQs

You need to ensure they are competent, trustworthy, and reliable — and even after checking references and having a few conversations, you may still have some lingering concerns.

We know the feeling because we’ve all been in that position before as clinical research associates. We know the stakes are high, and we’ve experienced the consequences of inexperienced staff or inconsistent processes in our previous roles.

We welcome your questions, and we want to address them in this post.

What Are Your Areas Of Expertise?

We have experience working with studies that target a variety of different therapeutic areas, including cardiology, orthopedics, in vitro diagnostics, neurology, wound care, and pediatrics.

We’ve also supported many different types of studies, including sponsor-funded research, such as feasibility studies, IDEs, 510(k)s and post-approval studies, and investigator-initiated IDEs from both the sponsor and site perspective.

What Makes IMARC Different From Other CROs?

We believe clinical trial success is based on careful planning, training and consistent application of a rigorous process rooted in regulations.

Our team sets the highest standards for site outcomes and study partnerships. We are committed to providing competent, confident oversight to ensure every study adheres to these standards to achieve the ultimate goal of worldwide approvals.

During a trial, clinical professionals encounter a number of hurdles that can put human subjects at risk, result in costly delays and even compromise the integrity of their study. Having independent oversight from a compliance-minded contract research organization can keep your trial on track and ensure you achieve regulatory approval.

Our team can support yours at any point in the process or manage your entire project, serving as a single point of contact between vendors and staff.

Learn more about our full-service support.

Clinical trial lifecycle

The biggest contributing factor to our success is the quality of our team. In an industry where turnover can be as high as 30%, many of our monitors have been with us for years. Our most successful hires have been people with prior clinical research experience, though that doesn’t necessarily mean they previously worked as monitors.

How Do You Screen And Train Monitors?

We look for monitors who are able to think critically and act with confidence to solve the inevitable problems that arise. For instance, if a monitor discovers a patient’s informed consent document is missing, they need to know how to handle the situation.

It’s not always easy to evaluate someone’s critical thinking skills on paper, so our process for hiring monitors is extensive. We have several rounds of interviews and ask a lot of open-ended questions to gain a better understanding of how a candidate would handle these challenges.

Although the FDA does not require any formal training for monitors, we believe training is an essential part of maintaining a consistent, compliant process.

Every new IMARC team member receives training in the basics of the Code of Federal Regulations (21CFR). They learn the regulations for electronic records, informed consent, human subject protection, financial disclosures and working with IRBs. They also learn the process for obtaining FDA approval of medical devices and how it differs from obtaining approval for drugs. Additionally, every staff member develops a good working knowledge of ISO regulations and ICH guidelines, including Good Clinical Practice (GCP.)

Once they have completed our standard onboarding and training, our monitors receive additional training to help them prepare for their specific responsibilities.

That includes training in the different types of site visits, monitoring activities, product accountability and adverse event review. They also learn how to answer questions that aren’t always obvious using our proprietary FAIR Shake™ framework.

Next, our monitors accompany an experienced team member for several monitoring visits. At first, they observe. Later, they take the lead as their trainer observes them.

This helps them become familiar with the process and gives them the confidence to be on their own. However, another one of our biggest advantages is that our monitors are never truly alone. They can always consult with the lead clinical research associate, project manager or another team member who is familiar with the study.

How Can You Help Us Comply With Global Regulations?

The new Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) both affect medical device companies doing business in Europe. These new regulations require additional data evidence for both new and existing medical devices.

As you consider what additional data you may need to comply with the new regulations, IMARC can help you develop a plan to obtain it.

Our team can also support you in your data collection efforts, including:

  • Conducting a full-blown clinical trial
  • Developing your strategy for retrospective data collection
  • Collecting real-world evidence
  • Choosing and implementing a robust data management system
  • Developing or improving a quality management system
  • Providing remote research coordination and site support for retrospective data collection

Learn more about post-market surveillance strategies that can help you comply with these new regulations.

How Do You Help Us Stay On Budget?

Budgeting is a vital element to any clinical study. It is important that the CRO you hire provides an accurate estimate and helps you contain costs throughout the study.  

At IMARC, we take pride in our ability to manage budgets and stay true to our budget estimates.

As a medium-size CRO with global partnerships and specific expertise in medical device trials, IMARC Research is the right size to support your clinical study support needs.

Ready to learn more? Request a consultation with us today.

Topics: Choosing a CRO

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