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On August 27^th, Exostar kicked off their “Partners Webinar Series” with Almac Clinical Technologies. The experts acknowledged the challenges of meeting enrollment requirements and timelines with clinical trials and sponsors increasing every year.  They discussed solutions that help attract and retain the right resources to meet your requirements and timelines.  There were some excellent questions asked. We are happy to share the Q&As in case you were wondering the same.

If you missed the webinar, you can still watch it on-demand at your convenience.

Answers to the questions from the webinar:

Q: How do you generally find the experience of IRT requirements gathering?

As an IRT vendor, we spend a lot of time trying to balance the need for minute details and the amount of time it takes to glean that level of detail from the client team. Our core system has a ton of capability and flexibility but clinical protocols have evolved and require more intricate designs. Our developers need lots of detail to ensure we are building exactly what the protocol demands. Knowing our client base are not necessarily technical experts, and have many other demands on their time, we have focused our efforts in requirements gathering on controlling what we can control and setting ourselves up for success as best we can on the custom items we can’t necessarily control. We take our queue from the protocol as much as we can and present the client with options on how we recommend handling the different items. We have found this to be effective and we can tailor the discussion to the IRT experience level of the client team. This minimizes the time sponsors need to spend with us and still gets us the level of detail we require to build out the systems.

Q: How often are you able to prepare eClinical infrastructure and data capture systems within adequate time for your trial?

We use separate groups internally to build out the main IRT system and the integration with other data systems. As a result these groups can work concurrently to deliver the integrations in step with the IRT study go live date. There are certain database design dependencies that have to be considered in each study when mapping out data integrations. Our project management staff highlights these dependencies in the kick off meeting and makes sure those items are spelled out in the project plan so they are finalized in time to start the integration builds to meet a common go live date.

Q: Based on your experience, what do think is the probability you will be caught off guard by the need to manage and implement protocol amendments?

The only constant in clinical research is change. Our system, processes and staffing model are all designed with flexibility in mind for this precise reason. We have never archived version 1 of an IRT system at the end of a study. Amendments are inevitable. The best way to manage change is to be prepared with established flexibility across your process so that you can adapt when the need for change arises. Transparent communication with clients about the progress of studies is key to minimize the likelihood for a surprise. If we are still caught off guard, we feel confident that our structure offers the flexibility to support even the most urgent change requests.

Q: How many sponsors have adopted single sign on with Almac IXRS using Exostar ID’s?

Almac Clinical Technologies currently has one sponsor using Exostar single sign-on (SSO) on all of their studies. Two others are working out the changes to their user provisioning processes to use Exostar on all of their studies. Three other sponsors are completing their evaluation and business cases.

What we are finding is using Exostar SSO is not a protocol by protocol decision. Sponsors are making these decisions at an enterprise level; this strategy enables sponsors to get the most value out of an SSO solution.

Q: I already have Single Sign-On.  What’s the difference with yours?

Many Sponsors have enabled Single Sign-On but only in the context of their studies. For these Site User who work with multiple sponsors, they unfortunately are still saddled with multiple logins. Exostar is the only identity that consolidates all of those logins into one across ALL sponsors for a true SINGLE Sign-On experience.

Q: How can I get an Exostar Account?

The Exostar identity is an invitation-only service so speak with your Sponsor and they’ll be able to set you up with one.

Q: We are mostly doing virtual clinical trials, using EMR records to identify patients, physicians and clinicians.  Can you talk about that? 

The virtualization of clinical trials is not an all or nothing proposition. The reality is there is a spectrum of virtualization opportunities in the clinical trial space. For example, virtual patient recruitment can occur by mining anonymized EHR/EMR data to find patients that are almost perfect fits for the clinical trial. Using telehealth visits for non-dispensation visits will save on sponsors’ travel expenses and patients’ time.  Getting to more efficient direct to patient IP shipping from both the clinical sites and depots, whichever local regulations will allow, will also limit the number of in-person visits required to continue in the clinical trial.

To bring this back to IXRS, Exostar, and eClinical systems, all of these virtualizes aspects of clinical trials will require different applications to manage them, opening the door to more site user credentials. As the virtualization of clinical trials grows in usage, the single sign-on value will grow with it.

Q: Site personnel managing multiple studies can lead to query aging due to not having enough time. Can you share some insights on helping sites with that?

Today’s talk focused on using Exostar single sign-on with eClinical systems and specifically about the IRT system IXRS 3. The focus of the site efficiency gained from using these two solutions together is the reduced number of user IDs held by site personnel and the time spent provisioning and de-provisioning all of these user accounts. The problem described in this question seems to be more data management centric and can be a real issue for sites that conduct many simultaneous clinical trials.

The challenge comes when queries start aging; it can cause a cascade effect of effort required for site personnel. The more queries that hit certain age thresholds at the site can trigger risk-based monitoring protocols that can require more monitoring visits, using up more of site personnel valuable time. The best way to solve these issues is to prevent them from happening in the first place. Some concrete mitigation strategies for these issues are well-built integrations that limit duplicate data entry and help initial data quality and only store data in systems responsible for said data and have easy means of stewarding that data during its lifespan.