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When your research teams return to work and your sites reopen, the safety of your patients and your staff must remain your top priority. Once you have determined it’s safe to reopen your sites or offices, you'll need to establish clear policies for how staff should conduct their research activities once they are permitted to return. IMARC is committed to assisting companies through this critical transition. We recently shared some recommendations from the FDA that can help you prepare. We will continue providing both remote and on-site services to keep your clinical trials on track. Please don't hesitate to contact us if we can help in any way.  
sandra

Respectfully,

Sandra Maddock, CEO

Global Full Service

Medical Device CRO

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Supporting You At Every Stage In Your Trial

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Real World Evidence

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IMARC’s team of monitors, auditors and experienced clinical research professionals provide comprehensive support, from planning to post-market data collection.
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Before

Clinical trial compliance starts with a strong strategy. IMARC can assist with establishing study protocols, developing a risk-based study plan and training your team to ensure human subject protection and data integrity.
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During

Managing all the moving parts of a medical device trial can be stressful. Our team can lighten your load by assisting with monitoring, data entry, vendor management, safety management and more. (And we’ll make sure the hand-off is seamless.)
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After

You’re so close to the finish line, but you still have a few more hurdles to clear. IMARC can assist with final audits, data lock and analysis and corrective action if your study receives a Form 483 or an FDA warning letter.
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Real World Evidence

To further ensure the safety of medical devices, the FDA is putting a greater emphasis on post-market data collection and surveillance. IMARC can help your team update these processes to comply with the FDA and the new European MDR regulations.
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Our team brings a wide range of experience and expertise in many areas, from cardiology, oncology & more. Learn more about how we can help your team.
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6 Emerging Medical Device Trends

Nanotechnology. Robotics. 3D printed devices. These are just a few of the exciting advancements transforming the medical device industry. Read more about the latest trends and how they could impact your clinical research. 

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The history of clinical research is both fascinating and troubling. It’s a series of trial and error—followed by regulations that put patient safety ahead of profits. And it’s the reason IMARC Research exists.
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Preparing for a BIMO FDA Inspection

To help research sites prepare for BIMO inspections, the FDA provides standard guidance to review. Get the whitepaper to learn how sponsors should prepare for BIMO Inspections.

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IMARC works with medical device companies around the world. We’ve formed partnerships that enable us to ensure your trial complies with all applicable regulations, no matter where you’re located.
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