Complion to Exhibit at MAGI's Clinical Research Conference - 2016 West

Posted by Complion on Oct 12, 2016 9:00:00 AM


Complion, the industry-leading document management and workflow platform for clinical research sites, will be exhibiting at MAGI's 2016 West Coast Clinical Research Conference in Las Vegas, Nevada from October 23–26.

The Complion team will be at the Planet Hollywood Resort & Hotel to connect with the research community and share best practices for managing clinical trial documents in a manner that improves efficiency and oversight.

Complion Founder and CEO, Rick Arlow, along will present a seminar on moving to an all-digital environment, “Paperless Clinical Trials,” along with Betsy Fallen, Global Head of Program & Business Developpment for SAFE-BioPharma Association.

MAGI West host over 100 sessions and workshops offering practical tips in a coherent program for operations, regulatory compliance, contracts and budgets. To learn more about this event, visit

Topics: News, Events

Complion to Exhibit at 2016 Global Site Solutions Summit

Posted by Complion on Oct 5, 2016 4:35:04 PM


Complion, the industry-leading document management and workflow platform for clinical research sites, will be exhibiting at the 2016 Global Site Solutions Summit in Boca Raton, Florida from October 13–16.

The Complion team will be at booth 504 to connect with the research community by sharing knowledge and experiences on regulatory and operational areas with attendees.

Members of Complion’s leadership team, Rick Arlow and Cristina Ferrazzano Yaussy will present at a Master Workshop, “Embrace a Paperless Process,” along with Jeremy Rigby, Executive Director of Advanced Clinical Research. During the workshop, attendees will engage in an interactive session exploring strategies related to implementing electronic document management systems. They will discuss best practices on improving workflow and novel processes related to managing regulatory documentation. Additional topics related to oversight, training, safety reporting, and DOA processes as well as critical components of CFR Part 11 Compliance will also be explored. Conference attendees can register for this Master Workshop here.

For the last 10 years, the Global Site Solutions Summit has been committed to being “the site’s meeting.” The Summit provides a unique hub where sites, sponsors, CRO executives and regulators come together and share best practices, build their businesses, and develop new partnerships.

To learn more about this event, visit

Topics: News, Events

Complion to Exhibit at SOCRA 25th Annual Conference

Posted by Complion on Sep 29, 2016 11:44:43 AM


Complion, the industry-leading document management and workflow platform for clinical research sites, will be exhibiting at SOCRA’s 2016 Annual Conference at the Montreal Convention Center from September 30th - October 1st.

The Complion team will be in Montreal at booth 17 to connect with the research community by sharing knowledge and experiences pertaining to regulatory and operational functions with attendees.

For the 25th year, SOCRA will welcome over 1,000 clinical research professionals from across the world. This three day conference will offer current information and tools, best practices, and training to assure that research professionals are up-to-date and compliant in their clinical research practice. To learn more about this event, visit

Topics: News, Events

FDA Inspections Need Not Be Stressfful: A Q&A With Dr. Harvey Arbit

Posted by Complion on Aug 2, 2016 2:07:55 PM

The following is based on a transcript of the Question and Answer portion of “FDA Inspections Need Not Be Stressful,” a Complion webcast featuring Dr. Harvey Arbit, PharmD, MBA, RAC, CCRP. Dr. Arbit is the president of Arbit Consulting, and is an adjunct professor at the University of Minnesota College of Pharmacy.


I work in medical device research. The FDA mandates that we implement 21 CFR 820.30 design controls, which we have done. How do I prevent scope creep from design controls becoming a full blown quality system with elements such as MRBs, dot control, cape, supplier audits and perhaps 50+ SOPs and forms to oversee; perhaps less than 20 total devices.

Dr. Arbit:

I believe the gist of the question is: if you’re a small company and you’re manufacturing devices, how compliant must you be with the QSR, which is the quality regulations?

You need to be compliant with all of them. The FDA really doesn’t care whether you have one device or a million devices. Each one must be in compliance with good manufacturing practice. In fact, the Food, Drug, and Cosmetic Act says that if your product is not manufactured under a good manufacturing practice, it is adulterated.


Will a 483 always be given at the end of an inspection?

Dr. Arbit:

The answer is no. There used to be little joke that went around that the FDA never leaves an inspection without leaving a 483. That’s not true. I have been involved in a number of inspections where the FDA has left without presenting a 483. There may have been some minor violations, which didn’t require any further action of the FDA’s part. Again, if you’re following your protocol, you’re following your SOPs, you’re following the laws and the regulations, you have nothing to worry about and the FDA probably will not leave a 483 and you will be in just fine shape.


Why does the FDAs have to post the warnings online publicly? Can’t they just assign the P.I.?

Dr. Arbit:

I think your question, if I can interpret is, why does the FDA have to identify the individual who is the recipient of the warning letter?

I think that is part of that whole process. It’s almost like paying for your crime. People are going to know who it is that is doing what kind of research. For example, if I were a pharmaceutical company and I’m looking for an investigator to study one of my drugs under an IND, one of the things that I’m going to be looking for is that investigator’s previous compliance record. Has that investigator ever gotten a warning letter? Yes, you can ask the investigator, but the investigator could say no and if the names of those investigators on the warning letters have been purged then you don’t know who got it. So, therefore, you can’t really perform due diligence. 

The same thing with investigators being disqualified. There’s a disqualification list and it names all of those investigators who have been disqualified. And again, you could ask an investigator if he/she has been disqualified, but they could say no. Then you do a search and you find out that in fact they have been. 

There is a real need to identify these people. It’s not there to embarrass them. In fact, oftentimes an investigator who gets a warning letter is actually in better shape than before. They’ve learned from it. They’ve made corrections. They’ve cleaned things up, and things go forward in a much better fashion.


When you receive a telephone call from the FDA for an inspection, what might you ask them to verify their true representation?

Dr. Arbit:

You’re thinking “is this a prank phone call?” Well, I guess we can’t even rely on Caller ID to ensure we know who we’re talking to. They’re not going to be asking for any specific information. They’re going to obviously introduce themselves, they’re probably going to ask for the P.I. on the study, and they’re going to know the name of the study. They’re going to tell you specifically why they’re calling and why they want to come in for an inspection.

You set up a date and time. Don’t give them any other information because at this point they have not issued a 482 and, therefore, the inspection has not started. Basically, all you’re doing now is confirming a meeting date for the FDA to come in and start their inspection.


Can you provide an example of SR, NSR assignment that might appear in the IRB minutes for a medical device study submitted for review?

Dr. Arbit:

That’s probably question for another topic, but let me see if I can address it quickly. Device studies are different from drug studies in that some studies are considered non-significant risk and others are considered significant risk. If it is a significant risk study -- in other words, if the device is one that is an implant or it sustains life or has some other similar purpose -- the FDA may say that this a significant risk study. In that case you would need to file—and I stress that word file—an IDE with the FDA and follow all of the IDE regulations in 812. If, on the other hand, the investigational device is not a significant risk, which is, in other words, the rest of the universe, then an IDE application is not submitted to the FDA but the regulations state that an IDE is considered to be in effect.

You then have to comply with the abbreviated IDE requirements, which is 812.2b, which basically says you’re going to keep records, you’re going to monitor, you’re going to get an informed consent, you’re going to have IRB approval, you’re going to label the devices. It’s really all the same requirements as full submitted IDE except the IDE doesn’t go to the FDA. Instead the IRB serves as the surrogate overseer. 

If you conduct your study as non-significant risk, that’s what the IRB has to put in their records. If you were to present your protocol to the IRB and say, “this protocol is non-significant risk,” and the FDA disagrees with you, then you may have to get the FDA involved to determine who’s right because the FDA may not approve your protocol until it is determined to be significant risk or non-significant risk. But it is a requirement for IRBs to review that significant risk/non-significant risk determination and document in their minutes as to what their response was.


How weighted are follow-up letters in reference to FDA inspection?

Dr. Arbit:

If I may, you’re asking if you respond to the 483, how much weight is given to that? A lot, if you can get it there before that whole package goes down to Washington because you may have made some corrections. Again, the FDA is looking for voluntary compliance and if you can voluntarily make all these corrections to the FDA’s satisfaction, you’re better off. If the FDA still issues the warning letter, your response to that warning letter is very important. If they don’t believe that you’re sincere in your response or they don’t think that you are really making changes or you haven’t put procedures in place to prevent those same incidences from happening in the future, they may come out and do another inspection. 

Your response is extremely important. Not only making the response, but being sincere and honest, showing integrity to make these corrections and to become compliant. Not just, “sorry we goofed up,” Your response should convey that you will look at these things more closely in the future, and provide assurance that all of your people are complying with the FDA regulations. 


When an academic institution is the holder of an IND, the institution is the sponsor, correct? If so, can the FDA audit the institution?

Dr. Arbit:

Correct! In some academic institutions, the University of Minnesota, for example, their policy is that if you’re going to be an investigator and it’s investigator initiated, and you need to file an IND, you will be the sponsor. There are some institutions where the institution’s policy requires the institution to always be the sponsor. Either way is fine. 

The FDA looks at sponsor investigator studies slightly differently than when the sponsor and the investigator are not the same. I’ve had that happen and had to explain to the FDA that it’s our policy that the institution holds the IND but it’s investigator initiated. Therefore, the institution is treating it as a sponsor investigator IND. 

But, yes, they can go in and they can now go to whoever is that individual who is representing the institution as the sponsor. They’re going to go in and they’re going to want to look at sponsor documentation. Because there can be similarities in sponsor obligations and the investigator requirements, just as there can be differences. You want to be sure that if your institution is the sponsor, there is somebody who is complying with sponsor obligations.


Does the FDA have specific audit tools or worksheets that they use for review? Are these sheets available to sites?

Dr. Arbit:

As mentioned in my presentation, the FDA provides instruction manuals for investigators that walk you through what they do, how they do it, and why they do it.



Editor’s Note: Links to these resources are available in the Complion feature webinar and feature article "FDA Inspections Need Not Be Stressful."

Topics: Insider

A Learning Experience

Posted by Complion on May 11, 2016 12:38:47 PM
It’s good when you can learn from your mistakes. It’s even better when you can learn from someone else’s mistakes.

Jill Heinz, owner and site manager of Treasure Valley Clinical research in Boise, ID, admits to a few missteps in the early stages of her implementation of Complion’s eRegBinder solution. At the time, enthusiasm for the new system and eagerness to start using it got best of her. Jill and her team dove in without much of a plan. It wasn’t long before they realized that the process they had in place was not working.

Jill and team went back to square one to begin a more deliberate transformation. They developed a new workflow for organizing and managing regulatory information, one that would take advantage of eRegBinder’s features. That new strategy paid off, and early wins helped to overcome staff reluctance to embrace the new system. Once word spread among staff members and stakeholders about the capabilities and benefits of the new system, the initial value only increased.

Jill shared details of her organization’s implementation experience during a recent Complion webinar, motivated by the hope that she could help others to avoid her mistakes. A detailed overview of her experience is now available from Complion, including recommendations for specific steps you can take to help to insure a smooth transformation from paper-based management of regulatory information to the speed and efficiency of eRegBinder.

Thanks to Jill’s openness and generosity you can learn from her mistakes. Don’t let that opportunity go to waste.

Click here to download your copy of “eRegulatory Experiences from a Site Without Binders.”

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Complion provides clinical research sites and their sponsors with a software platform to enable secure, compliant and efficient management of documents and administrative tasks. We would love to hear from you with any questions about our Insights blog or to learn more about our software platform.

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