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Compliance In Focus

remote services


Keep Your Clinical Trial Moving from a Distance

You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.


Newest Post

Posted by John Lehmann on Thu, Jun 17, 2021

3 Reasons Your Clinical Trial Fails To Meet Enrollment Targets


Many clinical researchers struggle to meet enrollment targets, especially over this past year.  There are many reasons, and some may be outside your team’s control.

However, with proper protocol development, site planning, and site selection, and accurate forecasting, you can mitigate some of these issues.

Here are three of the most common clinical trial enrollment challenges.

Posted by John Lehmann on Thu, Jun 03, 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.

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.

Topics: Choosing a CRO

Posted by John Lehmann on Thu, May 27, 2021

What’s New And What’s Next: Hybrid Approaches To Clinical Trial Oversight

After more than a year of conducting clinical research remotely, many sites are finally reopening. However, they’ve also adopted new ways of working that are likely to continue. 

Remote monitoring has the potential to offer greater flexibility and convenience while reducing costs in many cases. At the same time, some activities are still better suited for on-site interactions. 

In a recent Device Talks Tuesday discussion hosted by Mass Device, IMARC President Brandy Chittester joined three other clinical research leaders to discuss the future of monitoring and some of the challenges of the new hybrid approach. 

Topics: Clinical Monitoring

Posted by John Lehmann on Thu, May 20, 2021

Is Your CRO Too Limited In Scope?


We’ve talked about the challenges of working with large CROs, but it’s also possible for a contract research organization to be too small and limited in scope.

The fact is that CROs vary in the scope of services they provide. Some CROs are what we call niche CROs, which means they provide only specific services, such as clinical monitoring or data management.

You might initially think that’s all you need, but as you dive deeper into your clinical trial, you may realize you need support in other areas. By that time, it can be difficult to cut ties with your existing CRO or introduce another third-party provider.

Topics: Choosing a CRO

Posted by John Lehmann on Thu, May 13, 2021

What Is Good Clinical Practice Today?

The past has taught us many lessons, and one of them is the importance of rules, regulations, and standards. The goal of Good Clinical Practice (GCP) is to apply these collective standards to protect patients.

Let’s take a closer look at how history has shaped Good Clinical Practice, what guidelines it includes, and how GCP has changed in recent years.

Topics: Good Clinical Practice

Posted by John Lehmann on Tue, May 04, 2021

7 Drawbacks of Large CROs

There are plenty of options for medical device manufacturers looking for a contract research organization to support their clinical trial.

As smaller companies conduct more trials, the contract research organization (CRO) industry is expected to grow to $64.4 billion by 2027. However, this growth is accompanied by increasing consolidation. The top 5 CROs employ nearly 100,000 people and a single CRO can have thousands of clinical trials in progress at any time.

Consolidation within the past three to five years includes a number of high-profile mergers. These changes can lead to increased costs, internal conflict, difficulties managing change, and more. Our team has encountered these issues when some of our clients have enlisted our help “cleaning up” a clinical trial that has fallen behind or experienced difficulties that prevented the team from moving forward. In this post, we’ll share some of the most common concerns we’ve observed with large CROs.

Topics: Choosing a CRO

Posted by John Lehmann on Thu, Apr 29, 2021

3 Critical Ways The CRO Landscape Is Changing


Choosing the right contract research organization (CRO) is one of the most important decisions you’ll make in your clinical trial. The best CROs are true partners, supporting your study at every stage and ensuring compliance.

In recent years, however, finding the right CRO has become more challenging as the landscape has evolved. The global CRO market is expected to grow to $64 billion in the next five years as new technology, big data, and a growing need to renew patents all increase demand.

Here are three significant changes that could impact your choice.

Topics: Choosing a CRO

Posted by John Lehmann on Tue, Apr 27, 2021

[VIDEO] The Future of Clinical Monitoring

Clinical research monitoring today looks very different than it did just a year ago. 

While many research sites were already conducting some remote activities before the pandemic, it was more the exception than the norm.

Today, all signs point to a hybrid approach that combines on-site and remote activities. 

Topics: Clinical Monitoring

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.  

Topics: COVID-19

Posted by John Lehmann on Fri, Apr 16, 2021

The Declaration of Helsinki and Its Relevance To Clinical Research Today


Topics: Good Clinical Practice

Posted by Elizabeth Braschayko on Tue, Apr 06, 2021

Considering a Hybrid Approach To Research? Answer These Critical Questions First


As more people become vaccinated, many clinical researchers may soon resume on-site activities if they haven’t already.

However, it’s not likely we’ll return to exactly the way things were before. The way we work has changed. Our own research shows nearly three-fourths of clinical research professionals believe a hybrid approach that includes both on-site and remote activities will be the best way forward.

To ensure a successful transition, take some time to address these critical questions first.

Topics: Clinical Monitoring

Posted by Kelly Schindelholz on Tue, Mar 30, 2021

Does Remote Monitoring Really Save Time?

More than a year ago, we were all thrust into this remote monitoring world. There seems to be a perception that remote monitoring reduces clinical trial costs and saves time.

While this can certainly be true in some cases, we wanted to take a closer look at how remote monitoring has been impacting clinical trial costs and time.

Topics: Clinical Monitoring

Posted by Stephani Hulec on Tue, Mar 23, 2021

How Does Remote Monitoring Impact The Cost Of Clinical Trials?

Even after clinical research sites have reopened, it’s clear most sponsors and sites won’t be returning to the way things were before the pandemic.

After more than a year of remote monitoring, IMARC’s own research shows that most researchers prefer a hybrid approach that combines both remote and on-site activities.

However, it’s important to consider how this transition will affect the cost of clinical trials.

Topics: Clinical Monitoring

Posted by Elizabeth Braschayko on Tue, Apr 27, 2021

Survey Reveals The Future of Clinical Monitoring


After a year of performing clinical monitoring and many other research activities remotely, many sites are finally reopening. However, some of the new ways of working we’ve pivoted to out of necessity during the pandemic seem likely to become a more permanent part of clinical monitoring.

Remote monitoring has the potential to offer greater flexibility and convenience while reducing costs in many cases. At the same time, some activities are still better suited for on-site interactions.

Topics: Clinical Monitoring

Posted by John Lehmann on Tue, Mar 09, 2021

The Tuskegee Syphilis Study (1932 – 1972)

A recent Kaiser Family Foundation poll found over a third of Black Americans (35%) said they would probably or definitely not receive the coronavirus vaccine, compared to 27% of the general public.

Many have pointed out that this skepticism is rooted in unethical events in the history of clinical research, including the infamous Tuskegee syphilis study.

We're taking a closer look at what went wrong, the lasting impact it had, and what we can learn from it.

Topics: History of Clinical Research Timeline, The Tuskegee Syphilis Study, IMARC Research

Posted by Deborah Rovniak on Tue, Mar 02, 2021

Clinical Data Management: 4 Steps To Ensure Success

Good clinical data management is essential to every successful trial.

Topics: Clinical Data Management

Posted by Brandy Chittester on Thu, Mar 11, 2021

How to Properly Make a Correction to a Clinical Research Record

Most of us have been there before.  In an attempt to get that last item completed before the end of another long day on the job in the field, we inadvertently scribe the wrong date on the clinical research record we are completing. 

We are all human after all, and mistakes do happen from time to time.  Sometimes we know instantly and can correct ourselves. In other instances, someone else points out the discrepancy we may have overlooked.  It’s how we respond after we are made aware of the mistake that matters.

Topics: 21 CFR 812.140, Research Record, Case Report Form, Clinical Research

Posted by Rachel Silver-Kessler on Fri, Feb 12, 2021

What To Look For In An Electronic Data Capture System


Topics: Clinical Data Management

Posted by Rachel Silver-Kessler on Thu, Feb 04, 2021

EU MDR Compliance: How to Develop a Post-Market Surveillance Plan


Topics: Clinical Data Management

Posted by John Lehmann on Tue, Feb 02, 2021

How To Make Your Clinical Monitoring Efforts Matter


Whether you’re performing it on-site or remotely, clinical monitoring comes with many challenges. In the past decade (and even the past year), monitoring has evolved.

How should sponsors and sites define successful monitoring today, and what can they do to ensure they achieve their goals? Here’s a closer look at what monitoring should accomplish and how to improve outcomes.

Posted by Rachel Silver-Kessler on Thu, Jan 28, 2021

How to Prepare for a Seamless Virtual Audit

Audits are an important quality assurance step for ensuring safety and compliance in clinical research that complement the quality control activities such as monitoring.

Virtual audits have become increasingly common in the past year as more sponsors and sites look for ways to keep their trials moving forward in the midst of the pandemic. Although a virtual audit is often more convenient and cost-effective, it comes with additional considerations.

Here’s a closer look at the benefits of conducting a virtual audit and how to prepare for one.

Topics: Clinical Auditing

Posted by Katie Mitchell on Tue, Jan 26, 2021

When Can Sponsors Change Clinical Research Protocol?

There are times when a sponsor may implement a change to clinical research protocol prior to FDA approval.

Topics: Clinical Research Protocol

Posted by Stephani Hulec on Tue, Jan 19, 2021

11 Clinical Monitoring Skills Your Team Needs Now


The way many teams conduct clinical monitoring has been evolving for years, but the pandemic certainly accelerated the pace of change.

In a recent survey IMARC conducted of over 100 clinical research investigators and associates, 64% said they never or rarely conducted remote monitoring visits prior to the COVID-19 pandemic.

Today, nearly 60% said they are now doing so frequently, and almost 30% said they sometimes conduct remote monitoring.

Additionally, 73% believe a hybrid model that uses both remote and onsite visits will be the best approach in the future.

Topics: Clinical Monitoring

Posted by John Lehmann on Thu, Jan 14, 2021

6 Big Medical Device Stories Impacting The New Year

Even with one of the most stressful years behind us and COVID-19 vaccinations underway, some of the biggest healthcare and medical device stories will have a lasting impact on the clinical research community this year.

Topics: medical device trends

Posted by Cristina Calvin on Tue, Jan 12, 2021

Study Data Tabulation Model Implementation Guide for Medical Devices

Although different types of devices have widely varying data requirements, most Class II and III devices requiring regulatory data submissions share some fundamental characteristics.

How can you ensure you are submitting data in the proper format so that the FDA can process and review it?

Topics: Clinical Data Management

Posted by Cristina Calvin on Wed, Jan 06, 2021

New FDA Guidance For Submitting Electronic Study Data

When you’ve spent so much time obtaining data about your drug or medical device, you want to ensure the FDA processes and reviews it efficiently.

And these days, it’s much more likely you’ll be submitting that data electronically.

The FDA  recently issued updated guidance for submitting electronic standardized study data.

Topics: Clinical Data Management

Posted by Kelly Schindelholz on Mon, Dec 21, 2020

Serious Adverse Event Reporting: Everything You Need To Know

Reporting serious adverse events is a critical part of conducting a clinical trial. As important as this responsibility is, it can be confusing at times.

The FDA regulations for adverse event reporting leave some room for interpretation, and the requirements in the United States differ from those of other nations. Resource-conscious sponsors, on the other hand, are always seeking to do the right thing and avoid unnecessarily burdening investigators. 

Here is a detailed review of the international standards and U.S. regulations to guide clinical trial associates in reporting serious adverse events.

Topics: Safety Monitoring

Posted by John Lehmann on Thu, Dec 17, 2020

7 Creative Ways To Spend Your Clinical Budget Surplus

COVID-19 has upended many things, and the clinical research realm has hardly been immune to the impact. Many trials have been postponed, and research conferences have been canceled or gone virtual.

Topics: Study Budgets

Posted by Paul Cobb on Tue, Dec 08, 2020

Remote Review of Informed Consent: Implications for Monitoring

To participate in a clinical trial, a subject or subject’s legally authorized representative must provide informed consent (21 CFR Part 50).

Provision of consent not only grants permission for the clinical investigator to include the subject in a study but also for the sponsor/CRO to review the subject’s study records. Clinical research associates (CRAs) must verify informed consent prior to monitoring study data.

Topics: Informed Consent

Posted by John Lehmann on Tue, Dec 01, 2020

The Benefits of Using an Independent CRO to Manage Your DSMB or CEC

Not all studies require a data safety monitoring board (DSMB) or a clinical events committee (CEC), but these two independent groups can add tremendous value to your safety monitoring strategy.

Data safety monitoring boards review cumulative information from a study and monitor safety oversight with teams of independent physicians and medical professors. Clinical events committees adjudicate finite sets of adverse events within a study to determine if those events are related to the study or not.

While it is critical to understand the primary purposes of a DSMB or CEC, maintaining a good working relationship with these groups requires more than just regular meetings. 

A contract research organization (CRO) can help recruit and manage your DSMB or CEC. 

Here are three big benefits of hiring one to support your work with safety monitoring groups. 

Topics: CRO, CEC, DSMB

Posted by John Lehmann on Thu, Nov 19, 2020

3 Steps Data And Safety Managers Should Take Before A Clinical Trial

In our last post, we talked about the problems that can arise when data and safety managers aren’t aligned.

Topics: Clinical Data Management

Posted by Melanie Miller on Fri, Nov 13, 2020

Why Safety and Data Management Silos Can Be Dangerous

When it comes to collecting and reviewing clinical trial data, your data and safety management teams need to be closely aligned.

Topics: Clinical Data Management

Posted by Matt Carandang on Thu, Nov 05, 2020

New Reporting Requirements Under the Right to Try Act


The  Right to Try Act greatly expands access to eligible investigational drugs which are not yet FDA approved but could potentially help a patient with a terminal illness.


The Act was signed into law in May 2018. The FDA recently released proposed, annualized reporting requirements associated with the Right to Try Act to provide federal oversight of eligible patients.

Topics: The Right to Try Act

Posted by Brad Lieberman on Tue, Nov 03, 2020

Follow This CAPA Example To Correct And Prevent Issues

If your clinical research site has experienced serious process-level issues, a corrective and preventive action (CAPA) plan can help. 

Topics: CAPA

Posted by Sandra Maddock on Fri, Oct 30, 2020

The Scariest Issues We've Seen At Clinical Research Sites

As a global medical device CRO, IMARC is sometimes asked to “clean up” clinical research sites after things have gone wrong due to poor management or other issues.

Of the 113 sponsor, monitor, and CRO inspections the FDA’s Bioresearch Monitoring (BIMO) Program noted in its fiscal year 2019 report, 27% had some type of deficiency that required either voluntary action or official action.

Topics: Clinical Trial Lifecycle

Posted by John Lehmann on Tue, Oct 27, 2020

The Coronavirus Vaccine Trials: Which Companies Are in the Lead?

The coronavirus vaccine trials are well underway, with 11 vaccines now in Phase 3 testing globally, according to the World Health Organization’s vaccine tracker.

Dr. Jay Butler, deputy director of the US coronavirus vaccine initiative, Operation Warp Speed, said in a press conference Friday he believes it’s “reasonable to expect that we will have at least one, possibly two products available before the end of the calendar year.”

Posted by John Lehmann on Tue, Oct 20, 2020

Six Milestones in The History Of Vaccines

As the race for a COVID-19 vaccine continues, the stakes have never been higher; the pace of innovation, never faster.

Topics: History of Clinical Research

Posted by Brad Lieberman on Tue, May 11, 2021

Why Do You Need A CAPA Process?

A corrective and preventive action (CAPA) process can help address three possibilities we all fear in clinical trials:

  1. A patient’s safety, rights, or wellbeing is put at risk
  2. The study data is compromised or incomplete
  3. There are findings or even a warning letter that result from an FDA inspection

Topics: CAPA

Posted by John Lehmann on Tue, Oct 13, 2020

What are Good Documentation Practices In Clinical Research?

Whether on the site or at the sponsor level, we are asked to use Good Documentation Practices in clinical research. 

One might assume that a quick visit to the FDA website would produce the list of best practices.  However, there is no Code of Federal Regulations for clinical trial documentation. Here's a closer look at why Good Documentation Practices (GDP) are so important and some important guidelines to follow.

Topics: Good Documentation Practices, FDA, Clinical Research

Posted by Brandy Chittester on Thu, Oct 08, 2020

How to Prepare For A Clinical Monitoring Visit

A clinical monitoring visit is an important step to ensuring a study is maintaining compliance and staying on track. 

These days, more sponsors are supplementing on-site visits with remote monitoring. Regardless of the format, what happens before and after the visit is just as important as what happens during it.

As monitors, we spend a decent amount of time preparing for the visit – before we even head out the door. On the road, we’ve noticed that the most effective site coordinators tend to be those who also prepare for the visit. Spending an extra hour or two before the visit can decrease the amount of queries, follow-up items and even the length of the visit itself. 

Here is a short overview of what research coordinators can expect from a clinical trial monitoring visit and five steps they can take to prepare.

Topics: Coordinators, Meeting Preparation, Clinical Monitoring

Posted by Stephani Hulec on Tue, Oct 27, 2020

Risk-Based Monitoring: How To Prioritize In The ‘New Normal’

The COVID-19 pandemic has dramatically changed clinical research as we know it, forcing many clinical researchers to re-evaluate their priorities.

Topics: Clinical Monitoring

Posted by Katelyn Weed on Mon, Oct 26, 2020

Is A Note To File Really Necessary?

As a result of lacking documentation, missing data, or noted discrepancies, research professionals may turn to the use of a memo or note to file (NTF) to record and explain issues throughout a clinical trial.

We’ve all heard and advocated that “if it wasn’t documented, it wasn’t done”, but is a note to file the best way to remedy absent or deficient documentation?

Topics: Monitoring

Posted by Stephani Hulec on Mon, Sep 21, 2020

The Latest On Remote Monitoring of Clinical Trials

Recent developments in remote clinical trial monitoring indicate it might soon become part of the standard process for researchers.

Some of these developments have been visible to industry observers for the past decade. Others have been brought about by the global coronavirus pandemic.

Here’s an update on the state of remote monitoring of clinical trials.

Topics: Clinical Monitoring

Posted by Brandy Chittester on Mon, Nov 23, 2020

10 Keys For Responding to an FDA Warning Letter or Form 483

If one of your clinical research sites has received  an FDA warning letter or FDA Form 483, your first instinct may be to panic. It may also be tempting to look for someone to blame, which is equally unhelpful. 

Topics: Form 483, FDA, Warning Letters

Posted by Katelyn Weed on Tue, Sep 08, 2020

4 Ways CRAs Can Keep Research Coordinators Accountable

Research coordinators can bind the clinical research process together to ensure that a trial is efficient and compliant.

With subject safety, protocol and regulatory compliance, and quality data collection being at the forefront of their crucial role, research coordinators truly are vital to clinical research.

Topics: Research Coordinators

Posted by April Savarese on Thu, Sep 03, 2020

Navigating the Use of Online Platforms for Clinical Research

How often have we heard the phrase, “be careful what you put on the internet because you can’t take it back”?

Whether it be on social media, chat rooms or various websites, this has been especially important during the job interview process as many companies have started screening potential candidate’s internet presence to see if they would be a good fit for the company. Quite recently, we have seen in the news many stories of individuals who lost their jobs due to comments they made online that did not align with the company values.

Topics: medical device trends

Posted by John Lehmann on Tue, Sep 01, 2020

5 Wearable Medical Devices Transforming Clinical Research

Wearable medical devices are growing in popularity along with the rise of consumer-grade wearable technologies, such as fitness trackers and the Apple Watch.

Topics: medical device trends

Posted by Stephani Hulec on Thu, Aug 27, 2020

How IMARC Hires And Trains Our Monitors

As a global medical device CRO, monitoring has been at the core of our mission at IMARC since the company was founded over 20 years ago.

Topics: Clinical Monitoring

Posted by Brad Lieberman on Mon, Aug 24, 2020

How to Implement A Corrective And Preventive Action Plan

No matter your role in clinical research, you may encounter issues that require further investigation.

For instance, imagine you realize two medical devices  are missing. You eventually find them, but in the meantime you're concerned they could have been accidentally implanted into patients who were not study participants. 

Anytime you encounter a serious process-level issue, you should investigate the cause and create a corrective and preventive action plan, known as a CAPA.

Topics: CAPA

Posted by Stephani Hulec on Tue, Oct 27, 2020

5 Benefits of Hiring A Monitoring CRO

You already know monitoring is a critical part of protecting patients, ensuring compliance and maintaining data integrity in clinical research.

Topics: Clinical Monitoring

Posted by John Lehmann on Thu, Aug 13, 2020

3 Promising 3D Printing Medical Device Companies To Watch

The 3D printed medical devices industry has been gaining ground for years, and its growth has accelerated in recent months due to the coronavirus pandemic.

Topics: medical device trends

Posted by Kelly Schindelholz on Mon, Apr 19, 2021

Why Is It So Hard To Find Good Clinical Monitors?

Good clinical monitors are hard to find—and even harder to keep. If you’ve been experiencing this challenge at your sites, you’re not alone.

Topics: Clinical Monitoring

Posted by John Lehmann on Thu, Aug 06, 2020

5 Amazing New Releases From Medical Robotics Companies

In spite of the global pandemic, medical robotics companies haven’t stopped innovating.

Analysts predict the global healthcare robotics market will reach $30 billion by 2026.

Medical robots have been around for over two decades since the FDA first approved the da Vinci surgical system in 2000. However, medical robotics companies have introduced many new applications and enhancements since then, thanks to more recent technology such as artificial intelligence.

Topics: medical device trends

Posted by Kelly Schindelholz on Mon, Aug 10, 2020

Are These 9 Clinical Monitoring Obstacles Derailing Your Study?

Clinical monitoring is challenging enough when everything goes as planned.

Monitors are expected to review large volumes of study data and ensure your trial complies with all applicable FDA and ISO regulations, Institutional Review Board requirements and study protocol.

They are responsible for identifying compliance issues or inconsistencies before they lead to bigger problems that can cause delays or compromise data integrity.

When a monitor leaves or lacks proper training, it can impact your entire clinical trial. Here are nine common clinical monitoring obstacles you might encounter.

Topics: Clinical Monitoring

Posted by James Moat on Thu, Jul 30, 2020

How Will Nanotechnology In Medical Devices Transform Patient Care?

The use of nanotechnology in medical devices shows great promise for identifying and treating diseases with targeted precision.

By 2024, the global market for nanotech is expected to exceed $125 billion, according to an infographic by Visual Capitalist.

Topics: medical device trends

Posted by Katelyn Weed on Mon, Jul 27, 2020

3 Things I Wish I Knew as a Research Coordinator: From a Monitor’s Perspective

While the specific responsibilities and daily tasks for research coordinators can differ, it is irrefutable that research coordinators play an essential and significant role in clinical trials.

Topics: Research Coordinator

Posted by Brandy Chittester on Wed, Jul 22, 2020

What Is The Future of Artificial Intelligence in Clinical Research?

The use of artificial intelligence in clinical research shows great promise for transforming drug and device development.

AI refers to algorithms that train software to perform certain tasks and improve upon them over time by constantly analyzing new data.

Topics: medical device trends

Posted by Melanie Miller on Thu, Dec 17, 2020

These Online Clinical Research Courses Will Keep Your Team Sharp

With many team members continuing to work remotely, there has never been a better time to invest in online training. IMARC offers affordable online clinical research courses your team can take at their convenience.

Topics: IMARC University

Posted by April Savarese on Wed, Jul 15, 2020

What You Need To Know About Using Non-Contact Infrared Thermometers

Non-contact infrared thermometers have become a popular choice for conducting health screenings amid the COVID-19 pandemic.

Although they are considered to be less accurate than forehead, ear or digital thermometers, they pose the lowest risk of cross-contamination.

Topics: COVID-19

Posted by Elizabeth Zak on Mon, Jul 13, 2020

The Miracle of Telemedicine: Benefits And Drawbacks

In the era of COVID-19 and the uncertainty over whether an in-office doctor’s visit is worth the risk, telemedicine seems like a great solution.

You can connect with a doctor or specialist right from your living room couch and even get a prescription sent to your local drugstore for pickup.

Yet telehealth isn’t without concerns. Here’s a closer look at the pros and cons.

Topics: medical device trends

Posted by Rachel Silver-Kessler on Thu, Dec 17, 2020

Why Now Is The Time To Invest In Remote Clinical Research Training

A well-trained staff is key to the success and integrity of your clinical trial. Unfortunately, in busy times and when budgets are tight, clinical research training doesn’t always get the attention it deserves.

Topics: Clinical Training

Posted by Allison Sandoval on Mon, Jul 06, 2020

FDA Allows Emergency Use Authorization During COVID-19 Pandemic

The clinical research industry has seen many rapid changes over the past few months due to the continued presence of COVID-19.

With the evolution of this public health emergency, we have seen the FDA take action to provide real-time information and release new guidances, as well as provide Emergency Use Authorization for therapeutics used to detect and/or diagnose the virus.

Topics: COVID-19

Posted by Anna Eggleston on Wed, Jul 01, 2020

FDA’s New COVID MyStudies App for eConsenting

Each day we hear more updates on COVID-19 clinical trial testing with the hopes of finding a vaccination or cure for this deadly disease.

Topics: COVID-19

Posted by James Moat on Mon, Jun 29, 2020

What Does It Mean To Be Audit-Ready?

When it comes to auditing, being prepared is more than half the battle.

Topics: Auditing

Posted by Sandra Maddock on Mon, Nov 23, 2020

What Are The Benefits of Remote Auditing For Clinical Trials?

Remote auditing isn’t new, but it’s becoming more popular as clinical research teams become increasingly distributed.

Remote audits have also become more relevant recently as clinical trial operations transitioned from on-site to remote during the coronavirus pandemic.

If you’ve never considered remote auditing before, you might be wondering how it can benefit your trial and whether it’s the right approach for you.

Topics: "HoW", Auditing

Posted by Anna Eggleston on Mon, Jun 22, 2020

Organizing Tips for Research Coordinators

Research coordinators are the reason that many clinical trials are successful.

Setup, screening, enrollment, data collection, and regulatory maintenance are just a few tasks that coordinators manage for their study teams and investigators. The best research coordinators possess an attitude of credible excellence and a combination of learned/innate skills. Organization is key. Below are a few tips we have picked up from research coordinators over the years to help keep their studies organized.

Topics: Clinical Research

Posted by John Lehmann on Wed, Jun 17, 2020

FDA Warning Letters Reveal 2019 Inspection Findings

FDA warning letters provide insight into the most common inspection findings so clinical investigators can prevent them. 

Topics: BIMO FDA Inspection

Posted by Christian Barille on Tue, Jun 16, 2020

How To Obtain Feedback From The FDA After Your Device Establishment Receives A 483

Medical device manufacturers know that the FDA can inspect their establishment any time,

Topics: Form 483, Medical Device Manufacturers, FDA

Posted by Michael Marotta on Mon, Nov 23, 2020

EU MDR Requirements delayed until May 2021

In 2017, the European Union member states approved an amendment to the Medical Device Reporting (MDR) requirements which were set to be fully implemented on 26 May 2020.

Last September, our President, Brandy Chittester, and CEO, Sandra Maddock presented a webinar about the pending implementation of these requirements in order to review the purpose, impact, challenges, and strategies that should be considered when preparing for the implementation.

Topics: EU Device Regulations

Posted by Sandra Maddock on Tue, Jun 09, 2020

Five Medical Device Trends That Could Result from The Coronavirus Pandemic

The FDA reacted quickly when the coronavirus reached the United States.

In a matter of weeks, the agency issued emergency testing methods and allowed certain types of machines to be used as ventilators. It also approved a new ventilator-splitting device that allows one ventilator to be used by multiple patients to address shortages.

Topics: COVID-19

Posted by Melissa Wollerman on Wed, Jun 03, 2020

What Happens to Clinical Trial Sites When the Pandemic Restrictions Begin to Fade

It’s difficult to say if the clinical research world will return to “normal” once sites have opened their doors to patients, monitors and sponsors again.

Given the circumstances of these unprecedented times, there are bound to be challenges sites will face when the dust settles. However, there may also be new opportunities and alternative ways of conducting study procedures that were once thought to be the “standard”.

Topics: COVID-19

Posted by Sara Kalas on Mon, Jun 01, 2020

First At-Home COVID-19 Diagnostic Test

The first diagnostic test for at-home patient collection to detect COVID-19 was provided

Topics: COVID-19, Diagnostic Testing

Posted by Katelyn Weed on Thu, May 28, 2020

Can 3D Printing Medical Devices Solve PPE Shortages?

Using 3D printing for medical devices is becoming more common amid the COVID-19 pandemic, as demand for critical personal protective equipment (PPE) continues to outpace supply.

Topics: medical device trends

Posted by April Savarese on Tue, May 26, 2020

Does Remote Monitoring Make You Less Prepared For An FDA BIMO Inspection?

Remote monitoring has been encouraged since 2011, but due to COVID-19, we are seeing remote monitoring of clinical trials being utilized more frequently.

The technology to allow for remote monitoring visits has grown significantly in the past few years. These technologies can include electronic Trial Master Files (TMF), Institutional Review Board (IRB) portals, remote access to the electronic medical records (EMR), and even secure source document sharing systems.

With these technologies, monitors can gain access remotely to the same information they would be provided if they were on site. However, you might be wondering if remote monitoring has any disadvantages, particularly when it comes to FDA inspections.

Topics: Monitoring

Posted by Katelyn Weed on Wed, May 20, 2020

3D-Printed Medical Devices: The Process and the FDA’s Stance

3D printing, which is also known as additive manufacturing, involves a process in which two-dimensional layers of raw material are joined sequentially to build a rapidly constructed three-dimensional object.

The design and production of products using 3D printing have resulted in reduced material waste, conserved energy, and decreased time to bring products to the market. The capability of 3D printing can provide designers and manufacturers the flexibility of modifying a structural design without needing to alter machinery or tools in a manufacturing process. Such technological advancements have increased the use of 3D printing in the medical device industry.

Topics: Medical Devices, 3-D Printing

Posted by Amelia Vannello on Mon, May 18, 2020

Does Third Party Review of 510(k) Applications for Medical Devices Limit FDA Oversight and Risk Patient Safety

The FDA finalized and released their new Guidance For Industry for the 510(k) Third Party Review Program on March 12.

FDA’s Third Party 510(k) (3P510k) Review Program, formerly known as the Accredited Persons Program, allows device manufacturers to submit 510(k) applications for eligible devices to a Third Party Reviewer, who uses FDA criteria to evaluate the submission. Per the FDA, about 50% of the 510(k) submissions the agency receives are eligible for the Third Party Review Program.

Topics: FDA Approval

Posted by Sara Kalas on Thu, May 14, 2020

Productivity Models and Clinical Research Coordinators

As many of us can agree, Clinical Research Coordinators (CRC) strongly help shape the success

Topics: Clinical Research Coordinators, Productivity Models

Posted by Elizabeth Armstrong on Mon, May 11, 2020

New Considerations For Implementing E-Consent During COVID-19

As clinical trial sites and sponsors consider alternative approaches to conducting research during the coronavirus pandemic, the FDA recommends using electronic consent (e-consent) when possible.

Topics: COVID-19

Posted by Brandy Chittester on Thu, May 07, 2020

How to Safely Reopen Research Sites Following The Coronavirus Pandemic

While many clinical researchers have been doing their best to keep trials moving forward remotely amid the coronavirus pandemic, everyone is eager for their sites to reopen.

Topics: COVID-19

Posted by Katelyn Weed on Wed, May 06, 2020

Fraudulent, Unapproved Products Among the COVID-19 Pandemic

With the aim to contain and mitigate rapid spread, the global pandemic of the novel

Topics: COVID-19, Fraudulent Products

Posted by Anna Eggleston on Mon, May 04, 2020

When to Report COVID-19 Activities to the IRB

Determining when to report COVID-19 activities to the Investigational Review Board (IRB) can be a challenge.

The Office for Human Research Protection (OHRP) recently released guidance to answer how the Health and Human Services human subjects protection regulations (45 CFR 46) apply to actions taken by institutions and investigators in response to the Coronavirus (COVID-19) pandemic.

Here are a few common questions to consider.

Topics: COVID-19

Posted by Melissa Wollerman on Thu, Apr 30, 2020

6 High Level Components to Include in a Clinical Research Protocol

While there is an exponential amount of information that can be included within a clinical

Topics: clinical trial, Clinical Research Protocol

Posted by Melissa Wollerman on Mon, Apr 27, 2020

How To Manage Informed Consent And Protocol In A Pandemic

The novel coronavirus (COVID-19) has brought about many challenges for clinical trial study sites and subjects.

Because of these challenges, sites may encounter difficulties in obtaining informed consent, maintaining subject safety and adhering to protocol-mandated visits or follow-up procedures.

Topics: Informed Consent, COVID-19

Posted by Lauren Luzar on Thu, Apr 23, 2020

FDA Regulation of Diagnostic Testing During the Pandemic

Since there are currently no FDA approved or cleared diagnostic tests to detect SARS-CoV-2,

Topics: FDA, Pandemic, Diagnostic Testing

Posted by John Lehmann on Thu, May 07, 2020

How To Transition To A Remote Clinical Trial

The coronavirus pandemic has many researchers considering the possibility of conducting a remote clinical trial—or at least conducting some activities remotely.

Topics: COVID-19

Posted by Elizabeth Zak on Mon, Apr 20, 2020

What’s New with the Right to Try Act?

The Right to Try Act (RTT) was signed into law on 30 March 2018. Since conception, the bill has been controversial and the focus of debate. The bill was introduced in order to help terminally ill patients access investigational treatments which may help them. The FDA already had a process to provide patients with immediate life threatening diseases or conditions with access to investigational medical products; this process is called Expanded Access or “compassionate use.” Supporters of RTT Act argue this pathway (Expanded Access) is difficult to navigate and many patients pass away before being able to receive access; thus, defeating the purpose of providing a pathway to access investigational treatments at all. One main difference between Expanded Access and the RTT is that under the RTT, FDA approval is not needed which usually speeds up the process.

Topics: The Right to Try Act, RTT Act

Posted by Emily Zetzer on Fri, Apr 17, 2020

Insulin Gains New Pathway and What This Means for Patients

In a landmark move insulin, along with other biologic drugs transitioned to the biologics regulatory pathway as of March 23rd. This transition is groundbreaking for millions of Americans as incidence of diabetes increases and accessibility to affordable insulin has become a matter of life and death.

Topics: Biologics, Insulin

Posted by Tina Shah on Wed, Apr 15, 2020

Now Is The Time To Review Your Standard Operating Procedures

Your standard operating procedures (SOPs) provide the framework for a well-controlled, compliant clinical trial. 

These procedures are so fundamental, you may not have given them a second thought during busier times. Now, with many site activities stalled, your team members are looking for ways to stay productive. There’s no time like the present to revisit your SOPs to ensure they are up to date. Here are a few things to consider as you do.

Topics: Standard Operating Procedures, COVID-19

Posted by Natalie Jarmusik on Mon, Apr 13, 2020

Four Ways Clinical Researchers Can Stay Productive During a Pandemic


Topics: COVID-19

Posted by Amy Rooks on Fri, Apr 10, 2020

FDA Regulation of Face Masks and Respirators During the Pandemic

Last month, the Department of Health and Human Services estimated that the United States only had about 1% of the N95 respirators that would be required for medical professionals during the COVID-19 pandemic. 

The Assistant Secretary for Preparedness and Response, Dr. Robert Kadlec, while testifying before the Senate Committee on Health Education, Labor and Pensions, noted that “if it were to be a severe event, we would need 3.5 billion N95 respirator masks. We have about 35 million.” As hospitals across the country are struggling to obtain the appropriate personal protective equipment (PPE) for their providers, we are going to take a look into the FDA’s role in the regulation of these devices and the latest steps they have taken to increase the available supply during this pandemic.

Topics: FDA Regulations, COVID-19

Posted by Tina Shah on Wed, Apr 08, 2020

FAQs On FDA Guidance For Clinical Trials During The COVID-19 Pandemic

As a sponsor, you’ve probably had multiple meetings to determine next steps for your clinical trial during the COVID-19 pandemic following the FDA guidance released in March. Do you still feel stumped on how to proceed?

The FDA added an appendix with frequently asked questions and answers on its previously released guidance document on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.

Topics: COVID-19

Posted by Matt Carandang on Mon, Nov 23, 2020

Is Remote Clinical Trial Monitoring the New Norm?

The new coronavirus might be the tipping point for remote clinical trial monitoring, but technology has been taking us in this direction for a while.

This post will discuss trends in remote monitoring, how to support your research team from a distance and the benefits of using a contract research organization (CRO) to conduct remote monitoring.

Topics: COVID-19

Posted by Tina Shah on Mon, Mar 23, 2020

FDA Guidance for Conducting Clinical Trials During COVID-19 Pandemic

It has been recognized by the FDA that Coronavirus Disease 2019 (COVID-19) pandemic may impact clinical trials for drugs, medical devices, and biologics. Site closure, quarantines, and travel limitations are just some of the prevention factors that may make it problematic to conduct clinical trials. Alternative approaches and considerations are needed at this time in order to assure the safety of trial patients, good clinical practice, data integrity, and minimize risk.

Topics: Clinical Trials, The Coronavirus, COVID-19

Posted by John Lehmann on Fri, Feb 26, 2021

4 Clinical Trial Budgeting Pitfalls To Avoid

Budgeting for a clinical trial is challenging. Clinical trial sponsors do their best to anticipate every dollar they will need, but there are always unforeseen costs that emerge.

It’s better to be prepared for the unexpected than surprised by it later. An experienced clinical research organization (CRO) like ours has been through many clinical trials before, so they know what to expect and where teams most often encounter unforeseen costs.

Here are the four most significant areas where costs can add up.

Topics: Choosing a CRO

Posted by Ashton Steinhagen on Tue, Mar 10, 2020

The Coronavirus (COVID-19) and Clinical Research

With the uncertainty of the coronavirus (COVID-19), the impact of this global health issue remains to be seen. Recently, the FDA issued a news release indicating that together with help from the centers for disease control (CDC), they are trying to make more respirators available for health care personnel. The CDC requested emergency use authorization (EUA) which would allow the use of certain industrial respirators in the healthcare setting. These normally would not be approved for use in the clinical setting; however, the FDA stated that “…they may be effective in preventing health care personnel for airborne exposure, including the COVID-19.” As more cases continue to develop locally as well as abroad, more directives and urgent measures may occur.

Topics: Clinical Research, The Coronavirus, COVID-19

Posted by Ellisyn Scott on Tue, Feb 18, 2020

FDA’s Progressive Approval Pathway: Pros and Cons

The Food and Drug Administration (FDA) proposed a conditional progressive approval pathway for medical devices in April 2019. The proposal has met resistance by lawmakers and there are still unanswered questions.

Topics: Medical Devices, FDA Approval Pathway

Posted by Brandy Chittester on Tue, May 11, 2021

What Makes A Well-Controlled Clinical Trial?

A well-controlled clinical trial is much like a well-controlled experiment: They are both rooted in the cornerstone of the scientific method.

Fortunately for sponsors and their research teams, the FDA gives explicit guidance on what it means to run an adequate and well-controlled clinical trial in 21 CFR 314.126. 

Let's take a closer look. 

Topics: 21 CFR 314.126, FDA, Clinical Research

Posted by Emily Zetzer on Tue, Feb 11, 2020

FDA and FTC Collaborate to Improve Marketplace for Biological Products

Last week, the FDA and Federal Trade Commission (FTC) released a joint statement promoting collaboration to improve the marketplace for biological products, highlighting the necessity of incorporating biosimilars and interchangeable products and deterring anti-competitive behavior.  Biological products are defined by FDA as “a diverse category of products…may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs.”

Topics: FDA, Federal Trade Commission, Biosimilars, Biologics

Posted by John Lehmann on Wed, Feb 05, 2020

Everything You Need To Know About Clinical Monitoring

Clinical monitoring is the foundation for IMARC's services and a critical part of ensuring compliance. It's so fundamental, in fact, that sometimes it's easy to overlook the basics. 

In this post, we'll take a closer look at what monitoring entails and five steps you can take to ensure success. 

Topics: FDA, Clinical Trial Monitoring

Posted by John Lehmann on Mon, Nov 23, 2020

Four Medical Device Trends To Watch in 2020

To stay on the leading edge of innovation, today’s medical device manufacturers need to stay up to date on the latest trends and technologies.

Topics: Medical Devices