How Will You Be Inspection Ready Next Time? (Part 2)

In a business niche as highly critical, closely scrutinised and heavily regulated as pharmacovigilance it remains a puzzle why clinical development organisations struggle so often with the “end of process task” of distributing Safety Reports*. These are commonly known as Suspected Unexpected Serious Adverse Reaction or SUSARs. Timely safety report distribution is important because of its part in improving patient safety but also due to the compelling regulatory obligation to distribute this material promptly.

A Pharmacovigilance Process Summary

  1. Site reports Serious Adverse Reaction (SAR) within 48 hours.
  2. Sponsor determines if SAR is unexpected or not.
  3. Sponsor reports SUSAR to relevant regulators within days (for EMA within 7 days and typically 15 days for the FDA).
  4. In parallel to step 3 the sponsor has a responsibility to promptly inform other sites once the matter is identified as a safety issue. While there is some scope for interpretation here, “promptly” is normally interpreted as meaning a number of days and not some longer period of time. Typically sponsors will aim to distribute safety reports within 15 days.

For reference here is how the FDA explain things – p16 of FDA Guidance Safety Reporting Requirements for INDs and BA/BE Studies.

The reality is that this end of process task sounds simple to define but it is in fact pretty complex and time critical. In addition – organisations are often so blindly addicted to using email that alternative, more dynamic and reliable means of information distribution are strangely alien and fantastical. But why not use distribution means that allow for active information distribution, with real-time dynamic readership information? In an age where audience behaviour is closely tracked, isn’t it time you knew who has read your latest Safety Report, and more crucially who has not?

Real world perspectives from a clinical site, a sponsor, and a technology vendor.

myClin and Clinical Works recently organized the Clinical Innovators Summit (CIS) West Coast 2019 to help clinical trial professionals simplify, unify, and advance Oversight and collaboration processes in clinical trials. In part 2 of our “Inspection Readiness” discussion, we asked each of our panelists to reflect on the value of a system like myClin.

John Silowsky – Clinical Operations Consultant & Former Sr. Director Clinical Operations, Nektar Therapeutics

John Silowsky is a clinical research consultant who specializes in clinical operations.

“One of the great things about myClin is that you can clearly see that the communication has gone out and that it was received”

“I will use an example to explain how we used myClin. In the past, our IND safety reports would be sent out via email blasts. Only weeks later, a monitor would go out to confirm that someone, such as the Site Coordinator, had printed it, punched holes in it, and put it in a binder. If we were lucky, about 50% of the time there would be initials from the investigator, and only 50% of that time would he have actually dated it. Typically, it would take about three weeks to receive the signed and dated emergency report.”

“We recently used myClin on a study that I worked on for the distribution process of our IND safety reports. myClin requires certain people to interact with it and it gives you an in depth report on who has and hasn’t opened the report. For instance, it will tell us that Erin opened it at UF at 11:59 and 57 seconds on a Friday. We can also see that the investigator at least opened the file at 12:37 and 13 seconds and filed it.”

“Within 24 hours we can then have an internal person – maybe someone at our CRO – pull up a report which shows us which investigators have not yet viewed the report. This can start a chain rolling where within 24 to 48 hours we know and can communicate with these investigators as opposed to the every four to six weeks of monitoring visits that it took us in the past. So one of the great things about myClin is that you can clearly see that the communication has gone out and that it was received. While of course we can never prove that the information was absorbed, we at least know that they viewed it.”

Erin Silverman, Ph.D. CCC-SLP, CRCC, Research Coordinator and Adjunct Assistant Professor, University of Florida

Erin Silverman works as a pulmonary medicine research coordinator at the University of Florida.

“It provides a platform through which people-centered communication can occur, but still be documented.”

“I think that myClin saves an enormous amount of time for study coordinators. It makes the monitoring visits so much easier because for the most part, the monitor already has what they need to look at. This means that when they’re on site, they can focus on the issues that they can’t deal with from a distance, which is really important.”

“It provides a platform through which people-centered communication can occur, but still be documented. This is so important because at the moment we are overloaded with binders and paper. Buildings burn down, binders get destroyed, and liquids get spilled – meaning that important paper trails get lost. When you’re purely relying on a paper trail things can get messy. But with a portal like myClin, everybody is in the know and can assist where needed. For instance, if someone goes on leave for two weeks, others can keep an eye on important communication via myClin and jump in to help in an emergency situation. This could potentially save a data point that otherwise may have been lost.”

Lorne Cheeseman – Managing Director, Kestrel Biologic

Lorne Cheeseman has an extensive background in international clinical research.

“So when you get to the site you know that everyone has a current version of the SIV slides and manuals because they’re pulling it from myClin.”

“Just to highlight one thing in particular, the versioning of myClin. We’re just coming off one project where we were still developing the training documentation, like the SIV slide package, and we were able to keep track of the versions by having them on myClin. So we could see that this was still the first site. We know which version they used because we know when their SIV was and what version was current at that date.”

“Not only that, but also prior to the SIV, I would always have questions from the site asking me “what’s the agenda” and “what’s going to happen.” But now all the information is up on myClin. The site can review the slides there and get an overview of the agenda. Instead of sending out packages, we upload all the manuals that we’re going to review at the SIV onto myClin. The great thing is that they will have the current versions because as they go through the start-up process.”

“So when you get to the site you know that everyone has a current version of the SIV slides and manuals because they’re pulling it from myClin. In fact, at the SIV I was actually working off myClin in front of the site. So if there were people who weren’t familiar with myClin, they could see how I was pulling resources. At some of the sites, I was able to get the study coordinator behind the computer and doing all this. So it’s great for building that interaction. Also, you’ve got the most current version, but you can keep previous versions which means that you can refer back to what you did previously.”

Our next question to the panel was regarding what their experience was with mock inspections and how myClin helps in terms of ICH E6 R2.

John Silowsky – Clinical Operations Consultant & former Snr. Director Clinical Operations

“It’s going to be very interesting to see how mock inspections evolve because I think our experience has been with the old GCP guidelines. We’ve had the experience of being inspected by the FDA and I think the perfect storm is building.”

“There’s been a cross-collaboration between EMA and FDA and we have this newly adopted guidance document in place. So the culture between these inspectors is being merged and modified by the exchanges that they have. I think that our concept of mock inspections over the next couple of years is going to leave us surprised. I don’t want to say unprepared because anytime that you simulate something, you will get a bit further than you would’ve if you did nothing. But I do think that we are stepping into a grey area. We don’t know and we won’t know how to do mock inspections until they happen.”

Lorne Cheeseman – Managing Director, Kestrel Biologic

“Very different approaches between the FDA and EMA”

“We’ve had 24 years to get used to the first version of GCP. We know what the inspectors are looking for. We knew what they are after, and what questions they’d be asking. So it’s going to be interesting in the next couple of years to see what the new version is going to bring and what sort of things the inspectors are going to be looking for and asking for.”

“I also think that there are very different approaches between the FDA and EMA. I think the EMA focuses a lot more on whether you have the right processes in place. So it will be important to define those processes upfront, because the only thing the EMA is interested in is if you have a process in place.”

Erin Silverman, Ph.D. CCC-SLP, CRCC, Research Coordinator and Adjunct Assistant Professor, University of Florida

“It doesn’t matter how prepared you are. Nobody likes inspections.”

“I have an inspection coming up on Tuesday which I am sure I have everything in order for, and I’m terrified. I think this is where the relationship with the monitor comes into play. The ease of streamlining processes and having everything stored in one location (that isn’t a binder) is so crucial because it removes an element of stress for the site of having to figure out where things are. It’s about eliminating redundancy, streamlining, and having open communication with the site. We need to drive home the idea that this is a partnership. It’s not about me coming to catch you making mistakes. We need to work together to be successful and the process shouldn’t be more stress-inducing than it already is.”

James Denmark, CEO & Founder of myClin

“There are quite a few examples of the FDA and other regulatory bodies doing inspections on site in studies that used myClin. myClin is very rarely a central component of that – it’s just one more system – much like the binder and anything else. I’m glad to say that there have been no critical findings as a result.”

“I think the bottom line is whether inspectors are going to expect direct access or not. This is one of the big areas that we’re seeing changes in. They don’t want the old response where you’ve taken a screenshot and brought it in and shown it to them. They just want access to the system to be able to view it all for themselves. We don’t yet know how all of that shakes out, but in Europe, that’s what the EMA inspectors are saying. They want the same access that the coordinator has and they will decide for themselves whether it is good.”

Follow myClin and Clinical Works’ official pages and stay tuned for our next article on inspection readiness. Catch up on the Clinical Innovators Summit with this recap video and join our next event at

By Adam Wood, VP, Business Development at myClin

About myClin: Are you really ready for an inspection? Start using the myClin platform to take control of intricate and error-prone study documentation. Keep essential information at your fingertips to stay audit-ready at all times. Get started with more free resources and a demo at

About Clinical Works: Are you ready to move faster and smarter with a high impact, curated ClinOps team? We help new bio-pharm ventures and start-ups bridge the gap from investment to clinical development. Find out more at