Karin van Dort, product owner of Pharmasol’s psiXchange safety software solution, recently touched base with Outsourcing-Pharma to talk about the challenges associated with safety documentation in decentralized trials, and how to tackle them.
OSP: Could you please share an overview of Pharmasol: who you are, what you do, key capabilities, and what sets you apart?
KVD: Pharmasol started our journey as a systems integrator in 2001, providing consulting services for third-party software. As we moved to include hosting capability in our portfolio and focused more on pharmacovigilance, we became recognized as a PV specialist tech company.
We do continue to provide implementation and hosting for Oracle Argus Safety but have recently developed our own software, psiXchange, which automates the Safety Letter Distribution process and is integrated with any global safety database to streamline communication with sites.
OSP: Could you please give us an idea of how challenging it is to stay on top of safety documentation in clinical trials?
KVD: The challenges that are typically brought up when discussing clinical trials (pressure on timelines, trial complexity, increasing data volumes) are all valid in the area of Safety Letter Distribution. On top of this, though, are specific challenges relating to timelines and regulations, which differ from country to country.
OSP: How do those challenges increase or change when we're talking about a decentralized/remote trial, versus an onsite study?
KVD: Integration between systems is very important for decentralized trials. psiXchange depends on the provision of good quality contact data. That contact data is coming from various sources, all need to be and are supported by psiXchange.
Also, investigators should have easy, simple access to the safety documentation sent to them. psiXchange supports that by having a smart portal, Safety Central, with a unique way of accessing, which does not require the investigator to remember yet another username and password.
OSP: What are some of the most notable aspects of safety documents, and how do teams typically stay on top of these? Please talk about anything from adverse reaction docs, line listings, etc.
KVD: Once a serious adverse event is reported to a sponsor/pharmaceutical company, strict timelines apply to reporting this serious adverse event to Competent Authorities, Ethical Committees, and investigators. That is, if this serious adverse event is eligible for reporting.
So, having a system that provides automated decision-making of whom to report to is a big plus. Tracking via reports is important if, for example, investigators have acknowledged the information and will require remote access to that information along with the responsible CRAs.
PsiXchange will also track the safety document delivery, which is important for the safety teams because they must ensure that the safety information was successfully delivered to the applicable recipients. Another aspect of safety reporting made easy is the distribution of gap packs. Whenever a new site is activated in an ongoing clinical trial, the relevant safety information since the last Investigator Brochure has to be shared with the new site. This process is fully automated in psiXchange.
OSP: Please tell us a bit more about psiXchange, including how this technology works and what common problems/obstacles associated with safety documentation (especially with DCTs) it solves.
KVD: psiXchange was built to address this specific use case and ensure a focus on ease of use for sites. The software works by providing all study actors (PIs, ECs, Site coordinators, Internal Study Teams, CRAs) with immediate real-time access to the specific documents that they should be able to see. This “Site View” means that endless communication channels are avoided by providing everyone with the ability to understand immediately what remains to be acknowledged and with the transparent overview of everything that has already been provided and read.
Importantly, psiXchange addresses the shortcomings of legacy distribution platforms (portals) by eliminating the huge overhead associated with user account management (instead managed via two-factor authentication/One-time passwords) and adapting to the needs of different recipients. This means that all distributions can be located in a single study inbox, but can also be sent by email attachment, secure links, fax, courier, etc. but maintain an oversight of compliance since all distributions happen from psiXchange.
OSP: Specifically, how does the software automate the safety doc process, and why is this beneficial?
KVD: The typical approach when distributing safety documents remains very manual (even when using technology like a portal). psiXchange automates this process by using the knowledge that is inherent to the core sets of data that drive distribution. So, the safety letter itself has metadata about the originating study, compound, originating country, etc.
PsiXchange has the contacts for all studies (linked to a CTMS typically) so that it can combine this with the safety letter metadata and automatically create the distribution list.
Finally, the embedded country rules are checked with the distribution list to ensure only the required contacts are notified (this removes over-reporting and ensures regulatory compliance).
This automation removes significant manual efforts (which are both costly and error-prone) and speeds up the distribution process. So, as soon as a document is uploaded to psiXchange (or often sent indirectly from the Safety Database) it is distributed in real-time with no human intervention required.
OSP: Could you please talk about how initial response has been from early-adopting clients that have put psiXchange in action?
KVD: We have seen clients benefit from significant cost savings thanks to the automation and more importantly realizing both increased compliance and improved oversight. With PIs and other site staff able to more readily access all pertinent safety information and easily acknowledge it, the acceptance for the system is high, again leading to higher site responsiveness.