Eclipse hosted IRT Webinar: Implementing Drug Pooling Through Technology, featured panelist, Jeffrey Linstad on February 4th, 2015 at 2:00PM EST. The webinar addressed what exactly drug pooling is and what it means for IRT. Drug pooling requires IRT drug management to be able to supply multiple studies from a central drug schedule simultaneously. Examined were the benefits of drug pooling via the IRT system and follow up meetings offered to help kick start your IRT process. Watch this webinar for a discussion on the effective utilization of IRT for drug pooling, with one of the IRT creators discussing the benefits of drug pooling. Learn about having an effective IRT drug pooling system, how IRT systems’ drug pooling can consolidate supply lines and cut costs and receive knowledge that will act as a guideline for what you expect from an IRT system
Jeff Linstad: Mr. Linstad’s Clinical Technology career includes executive roles in the development and execution of global Clinical and Healthcare initiatives. With a Bachelor’s of Science Degree in Electrical and Computer Engineering from Merrimack College, Mr. Linstad leads, develops and directs the strategic clinical and healthcare technology operations for the clients of Eclipse Clinical Technology. Prior to joining Eclipse Clinical Technology, Mr. Linstad was employed by Phase Forward where he designed clinical solutions based on Phase Forward software (now Oracle Healthcare) to integrate with customers’ existing technical and non-technical processes.

Implementing Drug Pooling Through Interactive Response Technology Transcribed

Jeffrey Linstad: Today we are going to be taking a look at what is drug pooling and its role in drug management and drug accountability. What is the benefit of drug is pooling? learning how (Interactive response technologies) (IRT ) systems and drug pooling can consolidate drug supply lines and cut costs, types of drug pooling and some of the things that you should expect from an IRT system. In some cases sponsors will want to consider drug supply pooling for their larger clinical trial program studies. This allows them to consolidate drug supply lines and to cut costs. What exactly is drug pooling and what does it mean for IRT/IWR/IVRS ? Drug pooling is basically the provision of drugs or investigational product between central depots to multiple clinical trial protocols. It is becoming a more popular technique for drug management and centralizes drug accountability in similar clinical trials. Drug pooling interactive response technology manages to supply multiple studies from a central drug schedule assignment simultaneously. To do this well, IRT / IWR clinical trial drug management needs to be sophisticated enough to balance supply settings across multiple clinical trials while supplying them to a central supply source. Some of the benefits of drug pooling include reduced waste of drug supply through the IRT system, reduced costs of IRT (Interactive response technology) deployment and development, more effective provisioning of clinical supplies to investigational sites and especially sites that have greater demand and also the flexibility in your investigational product resupply strategy. There are many important things to consider when you are contemplating drug pooling using Interactive Response Technologies. The most important are choosing the right clinical technology company to handle your clinical supply management or have the proper clinical resources in-house and an IRT/IWR with the proper experience in Interactive response technologies. There are many things to consider when implementing the drug pooling for example, when setting up an IRT / IWR clinical technology for drug pooling there may be some kit types that will not be required for every clinical trial on the pool supply of drugs. Clinical trial “A” may have three types of drugs where clinical trial “B” only has two types. You need a clinical drug supply system that is intelligent enough to aid drug management in determining which kit types to ignore in each clinical trial and which kit types are going to be more in demand. Also consider that drug kits may be used by different countries with different import regulations. Some countries may allow import with 90 days of expiry while other countries may require supplies to be imported a year or more before their expiry date in the IRT / IWR system. So we really need to have an Interactive Response Technology that can handle not only multiple countries but across multiple clinical trials and with different active drugs available for each clinical trial. To accommodate this do not ship, do not count and do not dismiss and need to be set at the study level and apply to a common batch associated with the IRT/IWR pools supply. A drug algorithm is needed that will be able to look at all of your clinical studies and single site and supply the right information to the depot from the Interactive Response Technology System. Drug releases for pooled supplies are also more sophisticated in ranges of kits, may be released sooner for one IRT / IWR study than for others. Therefore it is really critical to ensure the kits being released by drug management are only truly available to the IRT study the release is available. These are some of the many complexities that make choosing an IRT / IWR over an Interactive Voice Response System (IVRS) a practical decision. So, when examining Interactive Response Technologies, select those that have been properly designed to handle IRT drug pooling. There are three basic types of drug pooling Interactive Response Technology: (1) pooling prior to labeling, (2) pooling at the depot where the kits reside without any specific protocol number and the protocol is added when the kits are shipped to the clinical technology site and (3) drug pooling at the sites. In this scenario, the protocols assigned to the kit as it dispenses to the subject., IRT pooling at the site-level is very complex and faces many regulatory hurdles additionally there are a lot of different local and regional regulations on this when you start dealing with the countries in Europe and across Asia as well. So site-level drug pooling can really be a challenge for drug management and you would need a clinical technology designed to support that activity. Today, we are going to do an IRT demonstration in the eclipse Interactive Response Technology system of pooling at the depot-level. Once IRT drug pooling has been implemented for drug management and drug accountability, the clinical technology keeps track of all of the information the IRT/IWRS needs to be able to supply studies with the use of IRT drug pooling. It’s important to have reports to look at the IRT drug supply not only at the program level as well as the study level and to track the central pool of supplies. The study level reports also need to give details on the IRT kits and there disposition if they have been requested or associated with the sites and subjects within the Interactive Response Technology System. Leveraging the reporting of the IRT/IWRS data base in combination with the IRT/IWRS data transfer to the IRT drug depot is vital to the success of the clinical supplies management team, here you can see an example of a drug management dashboard provided by the eclipse IWR system that gives the information at the site and at the study and the depot level within the eclipse IRT system. Additionally we have many IRT web reports and we will dig into this in more detail and we are going to go ahead and see a brief demo of the Interactive Response Technology System and Mo is going to give a little bit of a more in depth explanation of these eclipse IRT drug management dashboards.

IRT (Interactive Response Technology) Drug Pooling Demonstration

Moses Lam: This is a demo of the eclipse IRT system for drug management of pooled clinical supplies. The eclipse Interactive Response Technology has built in drug pooling capabilities. Allowing a central drug supplies data base to provision IRT drug supplies to one or more IRT/IWRS studies, building this feature by default allows faster IRT deployments as drug pooling is typically an expensive customization for most other Interactive Response Technologies and Interactive Web Response Systems. For this IRT/IWR demo I will be logging into our IRT demo study, study 106 as an unblinded supplies manager. When the unblinded supplies user logs into the eclipse IRT or Interactive Web Response Systems they are presented with an IRT drug supply dashboard, so they can effectively conduct drub management. This IRT/IWR drug management dashboard provides various graphs showing important details related to the IRT/IWRS study. Here on the left is an enrollment chart showing the enrollment estimation for this particular IRT study by date across all sites. In the middle we see the depot supplies bar graph which serves the supplies inventory of the central IRT drug pool for every drug type. This central drug database will be used to provision IRT drug supplies to any IRT/IWRS studies that are connected to the central IRT drug pool. This bar chart shows all available clinical supplies inventory by drug type, by depot and as you can see we have four depots by region and each clinical drug depot has four drug types in our interactive response technology system. Finally on the right there is the studies supplies inventory bar graph of the supplies inventory that is available for every one of our studies using our clinical trial technologies. Here we show our particular IRT clinical trial 106 and again each IRT study has four Interactive Response Technology drug types. Over the course of the study each chart will reflect changing levels of supply quantities as IRT drug supplies are released to various locations. This includes conducting drug management of clinical supplies between depots to various IRT / IWRS studies, in either depot-to-depot or sites-to-site scenarios via the IRT / IWRS. For this Interactive Response Technology demonstration I will be releasing drug supplies from our central drug database to both IRT clinical studies 106 and 107. I will then release IRT clinical trial drug supplies between depots so replenishing one depot to another within our central IRT drug database and then finally I will release the IRT drug supplies between site to site. From a drug management perspective, it is practical to release supplies from a site that has no enrollment to one that has higher enrollments. I am going to move this Interactive Response Technologies drug management dashboard aside and log in again from a different browser so that I can show the drug management before and after in our IRT/ IWRS. Here I login to our IRT clinical study 106, as the unblinded clinical supplies manager, and then I will go to the manual release menu of our drug management capabilities, releasing drugs from depot-to-site in the clinical trial technology system. In the IRT system I will be selecting depot 101 and then selecting Mass General, now both of these are marked. Both the depots and the sites have been registered to the US only IRT label group and so I will release drugs for all IRT/IWRS drug types and I will be doing quantity of 5 units for each IRT drug type. Once the release is completed in the clinical trial software the screen will give me a confirmation and an email will be sent out to users involved in drug management at the depot, along with an attachment of shipping order in PDF format from the Interactive Response Technology System. This gives me confirmation that the transaction went through. Now, I am going to go back to my IRT drug management dashboard and here I am just going to put this side–by-side. We went from depot 101 sending 25 quantities of each IRT drug type so here is the before and here is the after so that you can see that the quantities have gone down by 25 units and then here is the before picture of IRT study 106 of the available drug quantity and after the release we now see that the drug quantities have gone up by 25 units for all drug types in the eclipse IRT system. Again, I am going to leave this picture here to show the before and after from each of the Interactive response technologies system screens. I am going to do the same drug management process in the IRT system and this time I am going to release drugs from our Canadian depot to a different study, to study 107 within the IRT/IWRS. I am going to log out of the IRT system and I am going to log into my Canadian study which is study 107, also logging in as the IRT unblinded supplies manager, here is the IRT/ IWRS drug management dashboard again. We go to manual drug orders releasing from depot to site, so this time I am going to select my Canadian depot, depot 102 from my central IRT drug pool and I will pick a Canadian site in this IRT study, Montreal Clinic. Again I will be releasing from all drug types, this time I will do 30 quantities of each and once the transaction is completed, I will be seeing the confirmation on this screen for the IRT system and then it will go out to my depot with the shipping PDF form as an attachment. This level of drug management tracking significantly increases overall drug accountability. Now if I go and refresh my IRT drug management dashboard I will see that my Canadian depot 102 the quantity have gone down by 25 units for each drug type and my drug quantity for study 107 has gone up by 25 quantities. Again I am going to move this over here for the before and after to provide a visual difference from the one IRT screen to the other Interactive Response Technology screen. Now what I want to do is I am going to take some of the IRT drugs from this depot in my central database from depot 104 and I am going to replenish my depot 101 in the IRT/IWRS. This time I am going into the interactive response technology system to the manual order release depot-to-depot and I am going to pick depot 104 which has the US as a label group and I am going to my destination depot as depot 101. Both of these IRT sites are US only and therefore I can transmit drug across, for each drug type and do quantity 25 each for drug management and later for drug accountability. Wait for my confirmation that transaction has gone through from the Interactive Response Technology system and again once the transaction is completed, the emails will go out to the depot with the shipping PDF for the IRT system. Go back to my IRT drug management dashboard and now I can see that my quantities for depot 104 have come down while my quantities for depot 101 have gone up. So for each IRT drug type they have gone up by 25 units. I can also release drugs from one site to another in our eclipse Interactive Response Technology System. Here in my enrollment snapshot, in my enrollment chart I can see that I have one US site in the IRT system that, this is the Beth Israel site, that has low subject enrollment so this is a low performing site as a matter of fact the enrollment has actually tapered after April so I am going to be shutting down this particular site in the IRT system, but I want to transfer the available drugs from that site to my high performing site here in our eclipse Interactive Response Technologies system. I have got a site that is still doing pretty well with subject enrollment. In order to do that I go into my IRT/IWRS “manual orders” screen of drug management and this time I do a site-to-site release. I am going to transfer drugs from Beth Israel to St. Jude Hospital which is the high performing site in the IRT system and both are part of the US-only label group so that allows me to transfer clinical supplies and I am going to send everything out from Beth Israel IRT site so 10 quantities for each. Again the transmission forms will go out to the applicable parties that were sent the PDF from the Interactive Response Technology System. In summary we want to identify that the eclipse IRT/IWRS is designed and built with IRT drug pooling capabilities from the get-go compared to other clinical trial technology companies like Medidata, Endpoint or Cenduit. This gives you a more flexible IRT/IWRS system and a faster IRT/IWRS deployment than any other Interactive Response Technology System. The built in IRT drug pooling capabilities gives sites and sponsors the flexibility to manage IRT drug supplies from a central drug database and to provision drugs with multiple studies, to release drugs from a depot to another depot and to release drugs from one site to another within our eclipse IRT system.

Jeffrey Linstad: I hope that this IRT demo gave you a small insight into how drug pooling can impact drug management and drug accountability. When selecting a clinical technology you should consider efficiencies like what our IRT/IVRS system can provide. Today we focused on the manual aspects of IRT drug pooling and drug transfer for demonstration purposes. The eclipse IRT/IWRS also features an automated predictive IRT) drug algorithm that is fully drug pool configurable. Please feel free to reach out to us if you would like a more in depth demonstration of our Interactive Response Technology System. To summarize today, drug pooling offers a very cost effective way to help us streamline clinical supply changes in clinical trials through clinical trial technology and reduce waste and increase flexibility. IRT drug pooling is a relatively new and hot topic and as we come across we have faced various regulation hurdles within the Interactive Response Technology requirements, so it is very important that we work with a proper clinical trials supply management team/drug management team as well as the proper technology to help us move forward in this new clinical trial technology. It should be a deciding factor in IRT/IWRS systems design when applied to the program level. An IRT system that provides insight is critical when well designed reports are in place; the benefit of clinical supply management/drug management becomes clear. This concludes are presentation today and I would like to open it up to questions so I am going to ask Morgan Fowler our moderator to come online as well as Moses Lam and we will be happy to answer any questions that you may have regarding IRT and IRT drug pooling and once again if we don’t get to the questions today we will follow up with an email to you as well to answer any of your Interactive Response Technology questions. Any questions please feel free to type them into your go to meeting session for our IRT webinar.

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