Compliance In Focus

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently  released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.

Since the suicide death of Dan Markingson in May of 2004, there has been a lot of debate as to whether or not the 26 year old psychiatric patient should have been approached to consent to participate in a clinical research trial for the comparison of three atypical antipsychotic drugs. Recently, there has been an article published in the Minnesota Daily about a petition signed by over 3,000 ethicists, researchers and scholars asking the University of Minnesota’s President to review the case to prevent future tragedies at the institution. Such a petition was created due to several errors in processes related to human subject protection.

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.

Merriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something.  Case studies can be useful to help highlight how to handle a particular situation, including the eventual outcome.

IMARC Research continues to focus on being an industry thought leader through our whitepapers, infographics, speaking engagement and blogs.  During 2014, IMARC Research continued this tradition by publishing content that help inform and education our industry.

As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a new whitepaper that discusses the principles of risk management and their application to clinical research.

How is auditing different than monitoring?  Why do we need to audit?  Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

IMARC Research and TheraGenesis GmbH of Sutensee, Germany have signed a collaboration agreement to integrate and expand their combined resources, services and expertise in the development of medical devices. The agreement is solely a work-based collaboration with neither firm holding a financial stake in the other.

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

IMARC Research believes history provides important examples of clinical research misconduct  that have helped establish a foundation for understanding the principles that guide modern clinical research.  If you visit our offices, you will see artwork that is featured in our history of clinical research timeline hanging on our walls that depict critical events in history that have helped shape and improve modern clinical research for the well-being of human subjects.

When the words “Clinical Research Trial” are heard, many questions may come to one’s mind. What is being tested?  What is involved? Where will it be taking place? Who came up with the trial? Who is paying for it? What doctors are participating? Many of these answers for an Investigational Device (IDE) clinical research trial can be found on ClinicalTrals.gov.

As we continue to blog about the events that comprise our History of Clinical Research: A Timeline, we focus this month on the infamous Tuskegee Syphilis Study.

Please take time to download and review IMARC Research’s white paper on the FAIR Shake™ training program.  The goal of this white paper is to introduce you to the concept of the FAIR Shake™ in an effort to foster a pattern of thinking that will allow you to navigate through the complexity of the regulatory framework in a very simple way that is based in regulatory fact as opposed to popular opinion.

Recently, we have noticed an increase in the demand for training across the clinical research landscape.  This should come as no surprise with the constant advances in technology improving the way that clinical research studies are conducted.  Those of us involved in this privilege are continually striving to keep up, and continuing education is a regular part our profession.  In addition, FDA regulations require that individuals involved in the clinical research process be qualified by training and experience.  But what constitutes “adequate” training?  This a question often asked of us by the sponsors and investigators we work with.

As the clinical research world becomes increasingly technologically advanced, we have seen more and more sponsors choose to use Electronic Data Capture (EDC) Systems to document Case Report Form (CRF) data.  FDA published a guidance in September 2013 to address the questions associated with this growing trend.

Over the years, we have had many conversations with sponsors regarding their needs for monitoring support services.  It is clear that while many sponsors consider the outsourcing of their monitoring needs to a CRO, they have many concerns that they have shared with us.

As we in this industry are aware, turnover from both the sponsor and/or monitoring CRO is extremely high compared to other fields of service.  In order to have a monitor turnover rate lower than the industry standard, companies should recognize the importance of minimizing turnover whenever possible and proactively adapt strategies to do so.  However, in the event when turnover does occur, companies should also strive to make the transition to a new monitor as smooth as possible for both the sponsor and site(s).

While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset.  The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank.

Brandy Chittester, Director of Clinical Monitoring and Mary Lewis, Chief of Clinical Operations for IMARC Research will both be speaking at MAGI's Clinical Research Conference in Philadelphia, May 4-7, 2014. I hope you can join us and over 500 others.

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

You may be familiar with IMARC Research’s History of Clinical Research (HCR).  We recently released an eBook about it that briefly describes all of the images that currently make up the timeline.  If you have visited our office, you may have also been given a guided tour of one of our most renowned resources.  Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

Oftentimes there are questions about doing research with medical devices (as opposed to pharmaceuticals).  We recently highlighted in our whitepaper on the differences (and similarities) of doing research with drugs vs. devices, and also have an infographic summarizing the main points.

For the fifth year, IMARC has searched through the warning letters posted on the FDA’s website to compile a list of the top findings for clinical investigators. This year, we noted twelve warning letters that were issued in 2013. In the past years, the most common citings tend to revolve around failure to follow the clinical investigational plan, insufficient recordkeeping, and inadequate subject protection. Interested to see if the trends continued for 2013?

You may be familiar with IMARC Research’s History of Clinical Research (HCR).  We recently released an eBook about it that briefly describes all of the images that currently make up the timeline.  If you have visited our office, you may have also been given a guided tour of one of our most renowned resources.  Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

Several years ago, IMARC Research published a whitepaper outlining the similarities and differences between drug and device clinical trials.  Since IMARC focuses primarily in the medical device space, we felt it was important to highlight the differences between the two trials.  It has proven to be one of our more popular whitepapers, so we have decided to offer an infographic as a quick reference.

When a Sponsor-Investigator conducts a device study, it may be referred to as a Physician-Sponsored IDE (PS-IDE). Chaos can sometimes ensue when one begins down the path of a PS-IDE. This whitepaper will attempt to make sense of that chaos by providing a brief overview of initiating a PS-IDE, the responsibilities of the investigator, the additional sponsor responsibilities assumed by the Sponsor-Investigator, and a thoughtful discussion on the records and reports of the Sponsor-Investigator.  Relevant FDA warning letter findings issued to Sponsor-Investigators and some suggestions to ensure a well-controlled clinical study are reviewed.

We recently took a poll within the company regarding the following topic:  What is your favorite regulation, and why?  Here are some selected responses and the reasoning behind them:

For clinical research professionals, the protection of human subjects has always been of paramount importance.  Doing so while ensuring accurate and credible data are obtained are the primary roles for every individual on a research team.  Unfortunately, history reminds us that unethical research practices and/or disregard for the well-being of human subjects has not only occurred in the past, but continues to do so today.

Since the suicide death of Dan Markingson in May of 2004, there has been a lot of debate as to whether or not the 26 year old psychiatric patient should have been approached to consent to participate in a clinical research trial for the comparison of three atypical antipsychotic drugs. Recently, there has been an article published in the Minnesota Daily about a petition signed by over 3,000 ethicists, researchers and scholars asking the University of Minnesota’s President to review the case to prevent future tragedies at the institution. Such a petition was created due to several errors in processes related to human subject protection.

In a recent blog post, we provided an overview of the “Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” that the FDA released this past August.  Risk-based monitoring continues to remain a hot topic as the industry navigates its comfort level with this new approach.

In order to run a well-controlled compliant study at the site level, one must ensure that the study team has been trained, and is knowledgeable on the rules and regulations. Although it is the Investigator who is responsible for the conduct of the study, there is a larger team at work to complete all the required activities. The research coordinator carries out many of the day-to-day activities and touches nearly every study milestone.

IMARC Research has launched a new YouTube Channel that presents our people and services in a video format.  YouTube is the second largest search engine in the world (just behind Google) and since over 85% of Americans watch videos on-line, we thought it was time to launch our own channel.

IMARC Monitors sometimes have a challenging job; they are often on the road, trying to balance work and home life.  They juggle multiple studies from different Sponsors, have many relationships to maintain, sites to visit, and reports to write.  At IMARC we want to always provide the very best monitoring services we can.  In order to do that we must have great monitors on staff, so, what makes a great Monitor?

IMARC Research will be participating in BioOhio’s Regulatory Forum on October 3rd from 9:00 a.m. – 5:30 p.m. BioOhio has partnered with REU Associates to discuss regulatory issues that impact Ohio’s medical products industry. 

When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.

IMARC Research’s whitepaper investigates the differences between the drug and medical device clinical research process.  First and foremost, there is a common thread that ties the seemingly different clinical research processes together…patients.  Real people exist on the other side of an investigational product and they face risk when they choose to take part in a clinical research study.  So while the investigations of drugs and devices have their differences, by design these differences are intended to accomplish the game goal:  to safeguard those research participants while bringing safe and effective products to the market as quickly as possible.

There continues to be much discussion over the FDA’s 510(k) program, which has led to controversy and confusion over the direction of the program.  In fact, we have posted many blogs devoted to this topic, so we thought it was time to create a whitepaper focusing on the topic.

It is a common question that follows an informed consent document revision- does the subject need to re-sign? The answer could be yes or no depending on the type of revision that was made to the document. 

As the cell therapy market continues to grow, it’s important to note the similarities between medical device and cell therapy clinical trials. To help illustrate this, we’ve created an infographic, “Cell Therapy: The Fourth Pillar of Healthcare,” which is available for download.

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset.  The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank. 

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

Recent widespread recalls of investigational products have led to harsher scrutiny and stricter rules from the Food and Drug Administration (FDA). Steps take to prepare for trials in the past are no longer enough. The path to FDA approval requires tremendous organizational skills and attention to detail to navigate; but with the right preparation and commitment to compliance, all of these challenges can be overcome.

In order for a new medical product to reach patients it must first be proven safe and effective and then be approved for use by the governing regulatory body. Clinical trials are the vehicle to bring these innovative technologies to patients and evaluate them in support of regulatory approval. Unless a product is approved under the appropriate regulations for a specific use, it cannot be commercialized for that indication. In clinical research the products are still investigational, and even in a hospital setting, these products are treated differently.

Selecting outstanding sites is the key in running a well-controlled clinical trial.  Failure to identify outstanding sites could result in added costs and could lead to delays in bringing much needed products to the bedside.  Investing upfront time in the selection process could yield a positive return.  Today’s clinical research landscape typically allows for minimal resources under tight timelines, requiring sponsors to quickly, yet effectively, decide which sites are the right fit for the job. Selecting sites is the responsibility of the sponsor as outlined in ICH-GCP 5.6.1, 21 CFR 812.43, 21 CFR 312.50, and ISO 14155:2011(E). There is not a great deal of detail in these regulations to provide further guidance to sponsors. It is truly the sponsor’s responsibility to take the time at the start of the study to carefully examine potential sites and ask important questions during the review process.

IMARC Research, a  CRO offering monitoring, auditing and training services  and ImageIQ, an imaging contract research organization (CRO) and, have announced a partnership that will strengthen the abilities of both organization’s clients to manage the complexities of imaging within clinical trials, and to enhance FDA approvals by ensuring that scientific data is optimized and that processes are compliant.  ImageIQ will provide IMARC clients with their imaging and image analysis clinical trial expertise.  Conversely, IMARC will bring its 14 years of clinical trial management experience to ImageIQ clients that utilize ImageIQ’s imaging analytics and software development expertise.

The FDA Bioresearch Monitoring Program (BIMO) was created to: “Protect the rights, safety, and welfare of human research subjects involved in FDA-regulated clinical trials; Verify the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications; and To assess compliance with statutory requirements and FDA's regulations governing the conduct of clinical trials.” But, how exactly does FDA safeguard human subjects, ensure data integrity, and verify compliance with applicable standards?

We are pleased to announce that due to our continued growth, IMARC Research has moved to larger offices in order to accommodate our continued growth. Just 10 miles south of Cleveland Hopkins International Airport our Strongsville location will give us the added space and flexibility we need to continue to meet our clients’ needs in a high quality, efficient manner for many years to come!

While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset of those on a clinical research team.  The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank to facilitate running a well controlled, compliant clinical trial.

In the past we have written blogs providing criteria for selecting a Contract Research Organization (CRO).    When you’re a sponsor or investigator and you are faced with the decision of hiring a CRO, picking the right organization can be difficult.   Finding the right fit for your organization requires a well thought out process with many key points to consider.

We call it providing a "Third Set of Eyes."  Interestingly enough, most IMARC monitors have a background in nursing, or as research coordinators. It may very well be that this experience has assisted us in monitoring to empathize with each subject. After all, so many years were spent one-on-one with patients; we see them as individuals- not just subject numbers.

Today IMARC Research released its 23rd Issue of the IMARC eNewsletter and the last one of the 2012 year. As we reflect back on the year, IMARC Research has a lot to be thankful for. We continue to expand as the result of the trust placed in us by our clients and partners to handle their clinical research needs. We are thankful for these relationships that have helped us grow and prosper.

In clinical research having a well-run, compliant study is a top priority. Ensuring patients are protected and resulting data has integrity, it’s important to be experts in all aspects of your study. If your trial involves imaging, understanding how to get the most out of your data is not only smart- it’s cost effective. From a recent article published on GEN - Genetic Engineering & Biotechnology news, here are nine tips to help bring products to market faster with these ways of optimizing preclinical imaging:

Recently we sent out a tweet asking this simple question: What Motivates YOU in Clinical Research? We were excited to see this answered, and retweeted by those in our industry.

For all clinical trials, operating in compliance with the federal regulations, the agreements, the investigational plan, and the requirements of the IRB are critical to protect human subjects and to demonstrate quality and integrity of the resulting data. When imaging is introduced into a clinical research trial, a new layer of complexity is added, and additional considerations with regard to helping sites maintain compliance with the imaging requirements should be implemented.

We continue to reach out to our colleagues, customers, and friends in the most convenient places- from Facebook to Linked-In  to Twitter, and even in your very own inbox! Today we distributed the 21st issue of the IMARC e-Newsletter.

In order to run a well-controlled compliant study at the site level, one must ensure that the study team has been trained, and is knowledgeable on the rules and regulations. Although it is the Investigator who is responsible for the conduct of the study, there is a larger team at work to complete all the required activities. The research coordinator carries out many of the day-to-day activities and touches nearly every study milestone.

IMARC Research is announcing the addition of eight new team members to help accommodate our continued growth.  Seven of the employees will hold the position of clinical research associate (CRA) and one member will be joining the business staff.