Customer Interview:  K2 Medical Research- an FDA Regulated Company

Overview

K2 Medical conducts FDA-sponsored research for pharmaceutical companies. K2's quality and compliance teams needed an integrated learning management, quality management, and document management system to track quality and incidence metrics, house all of their standard operating procedures (SOP's), and automate their training and job role assignments. With several hundred employees, integration and automation has saved K2 time and enhanced K2 capabilities. K2 reflects on the quality of support, system customization, and training provided by SyberWorks during the implementation process.

SyberWorks: Welcome to the next edition of the SyberWorks LMS/DMS/QMS Implementation Interview Series, where we look at actual system implementations and e-learning program roll-outs.

SyberWorks specializes in custom e-learning solutions, learning management, document management, and quality management systems for corporations, governments, and non-profits. In this edition we are talking with Kristen Grube, Director of Compliance and Quality for K2 Medical Research about their use of the SyberWorks integrated LMS/DMS/QMS System.

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SyberWorks: Hi Kristen, thanks for meeting with us today. How are you?

Kristen: I’m doing well, thank you.

SyberWorks:  Could tell us a little bit about what your organization does?

Kristen:  I work for K2 Medical Research.  We conduct FDA-sponsored research for pharmaceutical companies, so we're responsible for following clinical trial protocols and adhering to FDA guidelines.   There's a lot of tracking and metrics involved to make sure that we're meeting all of our output goals.

SyberWorks:  Okay, and what is your role specifically at K2 Medical?

Kristen:  I'm the Director of Quality and Compliance, so metrics are very important to me.   I'm looking for red flags, trends, and things that are out of the ordinary. Also, I put into place all the procedures for our best practices, different reporting structures, and reporting metrics to the individual sites in the organization as a whole.

SyberWorks:  What led you to buy our LMS/DMS/QMS?

Kristen:  Well, I wasn't here when we initially started with SyberWorks, but I know that Marion McManus, one of our site managers, had some past experience with it and so we initially started with Syberworks just with the intention of housing all of our SOPs and using them basically as a repository for all of our new hires to review and sign off on their SOPs when they were hired.  That was really our only intention in the beginning.

SyberWorks:  Okay, and then you've added some of the quality management modules as well. How has that worked out for you?

Kristen:  Oh, it's been wonderful! I had some initiatives when I was hired for tracking incidents and deviations and other significant events that we keep tabs on and we have a lot of them.  We have hundreds of them a year and we needed an efficient way to manage them, so I had reached out to SyberWorks. You guys really were so accommodating. That I think is the most useful thing is that you work with us. 

You know, so many systems have a take it or leave it kind of thing and you hope that it works for what you need.  You guys have really worked with us every step of the way.  I mean I've been able to tell you here's what I'm looking for and you give me your recommendations but are able to accommodate what I need.

Then you throw in the custom reporting element which makes it really helpful.  We've been able to customize our search engines when we're looking for things and the workflow of who it routes to so we're using it for all of our Incident Reports.  We've started adding additional training as well so we are broadening our new-hire training to videos, PowerPoints, and things like that.  We've also started uploading to different job roles because it's efficient and it's working well.

SyberWorks:  That sounds great.  Is it possible to estimate what kind of time savings you have had with the incident reporting?

Kristen:  With the Incident Reporting I would say we're easily saving five to seven hours a week; it's a lot.  Before we had a manual form. I would have to review the manual form.  We were manually logging that data onto a spreadsheet so we could track it and then additionally to that time I would say probably five or six hours additionally a quarter because then I assemble a quarterly report to go to all of our leadership and I was having to just pull it out of a spreadsheet.  I mean it was a lot of duplicate work.  And now everything is streamlined and it routes to all the right people.  I think the whole process for each individual deviation is probably two to three days shorter because it appears in people's inboxes right away instead of that piece of paper that's sitting somewhere waiting for a signature.  Just from my team's perspective, I would say we're easily saving five hours or more a week because we're not having to manually re-enter and log all that data.

SyberWorks:  That’s great to hear. Do you see a need to implement CAPA or Change Control down the road?

Kristen:  I think that we're probably going to look at doing both.  I know CAPA is definitely in.  Luckily, we don't have too many of those at this time, so we haven't gotten to it yet but yes definitely CAPA and then Change Control. It's certainly something we need to implement.  I don't know if we'll do it electronically or just on paper but with the volume of things that we're producing at our site it seems likely that we'll use both in SyberWorks.

SyberWorks:  Are there any new tasks that have been enabled by using the system that was either just too hard to do before, too long or you just couldn't do?  Or were you pretty much doing things manually before?

Kristen:  We were doing things manually, but I will say that our training was very inconsistent because it had to be done manually. I think a lot of people weren't getting the training they needed and now because we've applied it to the Job Roles, everyone gets it.  And then you've been working with me on standardizing our training; that's another thing that we are looking to implement soon and we've been actively working on it. 

All of our standard training, I mean we have upwards of 10 training certificates that are not even study specific and we've been working on a way to house all of those.  SyberWorks is going to automatically remind people when their trainings are expiring and that's something we've not been keeping up with.   I mean we should be, but we just don't have the manpower to keep up with those hundreds of certificates!

Syberworks is going to automatically remind people when they’re expiring which is something that we've not been doing. That really hadn't been done too much because it was just kind of too labor intensive or didn't have time to keep up with it.  The people that were responsible just didn't have time and as we grew and had 200 employees, they just didn't have that information at their fingertips. Yes, we should have been doing it but I I don't feel like we were doing it consistently like we should have.  And now once it's in SyberWorks, everyone will have a lot of visibility and accountability for it.

SyberWorks:  So what would you say you like best about the product?

Kristen:  How customizable it is and how helpful and approachable I feel the SyberWorks staff is.  You pose the questions to me of what are you looking for and we work together to make it exactly what I want.  And you're always willing to change it once we get started, if we need some small tweaks.  And then you also are always available to walk me through it and show me how to use it.  I just feel like you guys are such a great resource and are very, very accommodating.

SyberWorks:  Right, that sounds good!  Are there any other areas that you would like to see added or improved?  In addition to Certificate Tracking, which we're working on now to help manage certifications, are there any other areas that you'd like to see either added or improved?

Kristen:  The only other one (I don't know if it would be useful in SyberWorks or not) but similar to our incident reports we do track they're called SAE’s. They're Serious Adverse Events and usually, these have to be done on a specific form, but we also internally track them.  I guess I'd have to think about how we’d do this.  I feel bad to throw it out there without a clear vision but if there was a way to track those similarly to how we do our other Incident Reports, I think it would be helpful for my team.  I just have to think about if there's a way to do it without adding a lot of work to the end user team. 

SyberWorks:  Right, is it a specific form or could it just be the appropriate data elements, kind of similar to an Incident, but probably different elements and different routing?

Kristen:  Unfortunately, it's a specific form and I think that's the part that makes it challenging.  It has to be a specific form that each pharmaceutical company provides us for each individual study.

SyberWorks:  For each sponsor, it's a different form.

Kristen:  Yes, that’s correct. I'm not sure if it would work or not, but in a perfect world, I like the idea of it being in there with my Incident Reports.  But because of the requirements, I'm not sure that it would work out.  But that's not SyberWorks’ fault!

SyberWorks:  Right, gotcha!  Okay, is there anything else that you'd like to add?

Kristen:  Really just that we've been beyond pleased!   We've added so many features because they’re so useful.  The system is so user-friendly and all of the “How-To Guides” are really helpful.  We couldn't be more pleased.   I mean, as you've seen, we're adding more and more things to the system because we can make it work for us and it's really wonderful!  It's really helped us.

I feel your staff is so patient, sometimes I feel terrible because SyberWorks spends all this time with me and then I come back and go oh I think I need to change this one thing. They are so patient!  They get everything just the way I want it.  I get to select all my options and my report options and it makes all the difference in the world.  The team is really wonderful.

SyberWorks:  Great, that’s awesome!  Well, thank you.

Kristen:  Thanks, I really appreciate it.

SyberWorks provides cost-effective solutions that extend the boundaries of traditional learning management systems. With over 25 years of experience delivering technology to meet the needs of highly regulated organizations, SyberWorks is the market leader in tailored, compliant learning experiences. See how SyberWorks can work for your organization.