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Ensuring Compliance Throughout The

CLINICAL TRIAL LIFECYCLE

 
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Here’s a look at a typical clinical trial lifecycle and how we can help you reach the finish line faster.

During a clinical trial, a number of hurdles can be encountered that can put human subjects at risk, result in costly delays and even compromise the integrity of the study. Having third-party oversight from a compliance-minded contract research organization keeps your trial on track and prevents human subject protection issues or data integrity issues from derailing your quest for approval.

IMARC Research can support your team at any point in the process, or manage your entire project, serving as a single point of contact between all stakeholders.

EXPLORE CLINICAL TRIAL LIFECYCLE move down

CLINICAL PLANNING

BEFORE
THE STUDY
DURING
THE STUDY
AFTER
THE STUDY

WHY IT MATTERS

On average, 80% of clinical trials experience delays of 1-6 months, costing thousands of dollars per day.

Having a proper understanding of the risks and a plan for mitigating them helps teams avoid costly delays.

80%

OF CLINICAL TRIALS EXPERIENCE DELAYS

HOW WE HELP

  • Regulatory Strategy/Plan
  • Protocol Development and Evaluation
  • Risk Assessments

WE ARE YOUR PARTNERS IN COMPLIANCE

Our team will act as a true partner, fully integrating with your teams and processes while providing objective, independent oversight and consulting.

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What’s It Like to Work With Us?

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STUDY LOGISTICS move down
before the study during the study after the study

STUDY CLOSEOUT

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AFTER
THE STUDY

WHY IT MATTERS

Clinical research investigations are required to be conducted in accordance with the applicable regulations, signed agreements, the investigational plan, and other conditions of the IRB or FDA, according to 21 CFR 812. Having complete, accurate study documentation is critical, and IMARC will ensure data is clean for analysis and reporting.

closing out

CLOSING OUT

HOW WE HELP

  • Final Audits
  • Data Lock & Analysis
  • Support through Inspections

Our Site Got a 483 ... Now What?

If your site receives a Form 483 from the FDA, you need to show you’re taking it seriously and take steps to make sure it won’t happen again. Get the guide to learn more about steps you can take to prevent future violations.

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How to Respond to a Form 483 

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IMARC: A TRUE COMPLIANCE PARTNER move down

STUDY LOGISTICS

BEFORE
THE STUDY
DURING
THE STUDY
AFTER
THE STUDY

WHY IT MATTERS

Your trial plans, resources and vendors set the foundation for your entire trial. Making mistakes in these early stages can have a snowball effect, causing bigger issues later.

Understanding the innate risks in clinical trials and setting up a plan to mitigate those risks can be key in ensuring a well-controlled clinical trial.

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STOP EARLY STAGE ISSUES

HOW WE HELP

  • Developing Risk-Based Oversight Plans
  • Identifying Resources
  • Vendor Evaluation & Selection

5 Hurdles to Overcome When Planning a Clinical Trial

Our team can help you devise the most effective strategy for your study, determine key milestones and identify opportunities to increase efficiency without compromising data integrity.

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Explore the 5 Hurdles

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STUDY IMPLEMENTATION move down

STUDY IMPLEMENTATION

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DURING
THE STUDY
AFTER
THE STUDY

WHY IT MATTERS

This stage of a trial tends to be the most chaotic, with many moving parts and opportunities for error. Mistakes or delays can quickly derail the trial.

reduce errors

REDUCE ERRORS

HOW WE HELP

  • Implement Risk-Based Plans
  • Train Study Team
  • Site Assessment and Selection
  • Site Initiation

Building the Business Case for Training

Having a properly trained clinical research staff is essential to ensuring compliance and bringing your device to market faster. Learn how you can achieve buy-in, set a budget and demonstrate ROI.

Building the Business Case CTA

Get the Guide

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ONGOING STUDY MANAGEMENT move down

ONGOING STUDY MANAGEMENT

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DURING
THE STUDY
AFTER
THE STUDY

WHY IT MATTERS

A clinical trial has many moving parts that must work together efficiently. There are multiple communications to manage between points of contact and key milestones to meet. To keep everything running smoothly, it’s important to have someone who can see the big picture.

keep moving forward

KEEP MOVING FORWARD

monitoring

MONITORING

auditing

AUDITING

implementing risk-based plans

IMPLEMENTING RISK-BASED PLANS

remote site support

REMOTE SITE SUPPORT

saftey monitoring

SAFETY MONITORING

vendor management & communication

VENDOR MANAGEMENT & COMMUNICATION

staff training

STAFF TRAINING

change management

CHANGE MANAGEMENT

Adding Value to a Study with a Safety Monitoring Group

A safety monitoring group such as a DSMB or CEC is an investment in safety and data integrity that goes beyond checking a box.

Data Safety Monitoring Group CTA

Safety Monitoring Whitepaper

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STUDY CLOSEOUT move down

A TRUE COMPLIANCE PARTNER

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IMARC Research is a medical device CRO with nearly two decades of experience ensuring patient protection, data integrity and regulatory compliance at every stage in the clinical research process. We have a stellar record with the FDA and the expertise to navigate the complexities of medical device studies. Revisit the clinical trial lifecycle.

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CONTACT IMARC RESEARCH

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WANT TO LEARN MORE ABOUT WHAT IT'S LIKE TO WORK WITH US?

Explore success stories of companies like yours in our newest resource, Working With IMARC.

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