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How Does A Full-Service Medical Device CRO Support Your Clinical Trial?

A contract research organization (CRO) can add tremendous value to your trial by overseeing critical compliance elements and providing additional support with routine activities to keep your trial on track.

As a full-service medical device CRO, IMARC is uniquely equipped to support your clinical trial at every stage in the process. We can manage your entire project or assist with specific tasks as needed.

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

All Clinical Study Stages

Full-Service Support At All Clinical Study Stages

Before The Study

  • Clinical Planning
    Regulatory Strategy
    Protocol Development
    Legal Input
    Risk Assessments
  • Study Logistics
    Risk-Based Oversight
    Plans
    Identify Resources
    Vendor Evaluation and Selection

During The Study

  • Study Implementation Training
    Site Selection And Activation
  • Ongoing Study Management Monitoring
    Auditing
    Site Support
    Project Management
    Safety Monitoring
    Data Management
    Vendor Management
    Communication
    Retraining

After The Study

  • Study Close-Out Final Audits
    Data Lock and Analysis
    Clinical Study Report
    Inspection Support
  • Regulatory Submission and Study Approval
Our Services

Our Services

clinical_planning
Clinical Planning
study_logistics
Study Logistics
implementation
Implementation & Training
monitoring
Monitoring
auditing
Auditing
safety_monitoring
Safety Monitoring
data_management
Data Management
Clinical Planning

The planning stage sets expectations for how your team will work together.

First, you need a regulatory strategy that aligns compliance activities with your business objectives. Next, you'll need to establish protocols that protect patients without making the trial overly restrictive.  Finally, you'll want to establish a risk-based monitoring plan that takes into account your trial's unique characteristics. 

See how our FAIR Shake™ method helps you ensure compliance from the start.

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Overcome Planning Hurdles

You can avoid a lot of time and hassle later with proper planning. Discover the five most common hurdles that derail trials and how to avoid them in your planning process. 

Study Logistics

Your team may need help with site selection, initiation, or patient enrollment before getting started. 

Once your sites are up and running, you may also experience delays due to staff shortages or gaps in your process. 

Our team can assist with all the logistics needed to begin your trial and support your research coordinators as you go. That includes assisting with data entry and resolving discrepancies. 

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Simplify Site Selection & Setup

Site selection and setup is a critical and underrated part of the clinical research process. Discover what factors are most important to consider as you choose sites, recruit patients, manage informed consent, and more. 

 

Implementation & Training

The cost of implementing, conducting and monitoring a large clinical research trial can cost as much as $1 million per site, according to the National Center For Biotechnology Information. Failing to follow the protocol at the site level can invalidate data, potentially resulting in hundreds of thousands of dollars in wasted resources. That's not counting the revenue lost from delays.

Having a properly trained staff is your best defense against compliance issues that can derail your trial. 

We can support your team with customized training online or in person. 

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IMARC University Course Catalog

IMARC University offers comprehensive training, including programs for specific research roles and individual courses. Training is convenient and cost-effective. Download our course catalog to explore courses.  

Monitoring

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 states 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. 

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Prepare For the Future of Monitoring

Our own research found 75% of clinical research professionals believe a hybrid approach that combines on-site and remote activities is the future of monitoring. Discover how to adapt your processes and budget for this new environment.

Auditing

Every year, the FDA releases the most common inspection findings — and every year, some common themes emerge. 

Regular audits can help you identify compliance issues before the FDA does and address them before they become bigger problems. 

We can conduct in-person or remote clinical research audits, including: 

  • Site GCP audits
  • Vendor qualification audits
  • Sponsor/CRO audits
  • Trial master file audits

We'll also train your team in best practices throughout the process.

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Ace Your Next BIMO Inspection

To help research sites prepare for BIMO inspections, the FDA provides standard guidance to review and metrics explaining the most common findings. Download our BIMO whitepaper and learn how to prepare your teams to pass. 

Safety Monitoring

Every successful clinical trial must protect patients while collecting complete, accurate data that proves the safety and effectiveness of the drug or device.

To achieve this, you need to work closely with your data management team as well as safety monitoring groups like your data safety monitoring board or clinical events committee.

IMARC also offers full-service safety management. That includes recruiting qualified physicians for a DSMB or CEC, communicating with members, and documenting meetings. 

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Do You Need A DSMB, A CEC Or Both? 

The two primary boards are the data safety monitoring board or data monitoring committee (DSMB or DMC) and the clinical events committee (CEC). The use of these boards may be required, but in most cases, the decision to use them is open to interpretation. 

Does your trial need a DSMB, CEC or both? Here are some guidelines to consider as you plan your trial.

Data Management

Like Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP) are based on regulations and guidance. Specifically, clinical research sponsors, principal investigators, and others can refer to the guidelines outlined by the Society for Clinical Data Management and 21CFR Part 11 regarding data management of electronic records. 

Our team follows an established process for consistent data and safety management. 

We can help you select the right electronic data capture system, build it according to your specifications and work with site monitors to ensure data is entered accurately and in a timely manner. If you have decided to use electronic patient-reported outcomes, such as questionnaires, we can help you manage that process and ensure compliance. 

We can also sort, clean and analyze your clinical trial data and assist with database locking as your trial comes to a close. 

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Get Your Data And Safety Managers On The Same Team

Without alignment and strong communication between your data and safety management teams from the start, you could miss critical data points or duplicate efforts. Here's a closer look at common data and safety management challenges and how to improve collaboration during your trial. 

How we can help

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