14th September 2022
Welcome to the Autumn 2022 edition of our quarterly customer newsletter.
We’re kicking off the new season with a busy live event schedule – exhibiting and speaking at World Drug Safety Europe this week in Amsterdam, and also heading to PIPA Conference 2022 in the UK. You can find out more about both events and how to meet us there later in this issue, and our Industry Commentary offers an overview of our conference presentation, setting out the compelling business case for safety reporting automation.
In a very special Roadmap Update for this edition, our CEO Torsten Adam and psiXchange Product Owner Karin van Dort share an exclusive preview of the exciting updates coming down the track when psiXchange version 3.0 launches next year. You won’t want to miss this sneak peek under the hood…
Our customer success story profiles US pharmacovigilance-specific Clinical Research Organisation Drug Safety Navigator LLC. Vice President of Global Safety Operations Lynda Baxter explains just how the DSN team has gained from implementing pharmasol’s accelerated system deployment for Oracle Argus Safety, rapidLIVE.
We hope you enjoy reading and do please share your comments and questions with us here or via our Linked and Twitter channels – we’d love to hear your thoughts.
If you’d like to book a meeting with the pharmasol team to discuss your organisation’s key pharmacovigilance challenges and explore how we can help boost your compliance while lowering costs, please just get in touch.
We look forward to connecting with you.
Chief Sales Officer
+44 118 328 2629
In this newsletter:
NEWS: PharmaLex to join AmerisourceBergen – healthcare leader expands global biopharma services platform with acquisition of PharmaLex
Leading global healthcare company AmerisourceBergen Corporation (NYSE: ABC) has announced that it has signed a definitive agreement to acquire PharmaLex Holding GmbH – enhancing AmerisourceBergen’s global portfolio of solutions to support manufacturer partners across the pharmaceutical development and commercialisation journey.
Earlier this year, pharmasol announced the formal completion of our merger with PharmaLex – one of the world’s largest providers of specialised services for the pharma, biotech and medtech industries. This strategic consolidation brought to PharmaLex Group our industry-leading safety document distribution platform, psiXchange, plus our broad portfolio of full-service pharmacovigilance business support capabilities. Now, this acquisition of the consolidated Group by AmerisourceBergen is set to further boost the global footprints and capabilities of both organisations, delivering end-to-end service offerings that are tailored to meet the needs of customers’ product at every point in the lifecycle, and widening access to proven solutions, scalability and diverse perspectives to successfully bring clients’ innovative products to market.
The acquisition of PharmaLex will build upon AmerisourceBergen’s existing European presence in pharmaceutical distribution and biopharma manufacturer services capabilities, strengthening its differentiated position to capture significant growth opportunities in the biopharma market.
“AmerisourceBergen is committed to building on our leadership in specialty services through a continued focus on innovation and partnerships, and by acquiring PharmaLex, we will be able to further enhance our value proposition to pharmaceutical manufacturers, from emerging biotechs to global biopharmaceutical leaders. PharmaLex’s highly complementary business and strong market reputation will deepen our partnerships with manufacturers, advancing our role as a strategic partner of choice as we support end-to-end clinical and commercial enablement solutions for our pharma customers. We look forward to welcoming the PharmaLex team to create healthier futures with AmerisourceBergen.”
Steven H. Collis, Chairman, President & Chief Executive Officer, AmerisourceBergen
The acquisition is currently undergoing regulatory review, which is targeted to be finalised by March 2023. You can access the full announcement here.
For pharmaceutical businesses, biotech companies and Clinical Research Organisations, the distribution of safety letters is a business-critical task, but one that can be extremely time and resource-intensive. Throughout the safety reporting process, regulatory compliance must be ensured at all times, with the clinical trial sponsor ultimately held accountable for errors or lapses.
There are several key operational challenges inherent in the process, not least the large number of different recipients involved (spanning sites, LECs/CECs and CAs), plus the need to diligently track distributions and acknowledgements to ensure compliance – both regulatory and procedural. Added to this are the ongoing requirements for a keen knowledge of global regulatory intelligence, the need for local expertise, and an overall drive to deliver inspection-readiness and consistent quality and reproducibility of a non-trivial process.
Typically, safety document distribution is approached by clinical trial sponsors in one of three ways:
The limitations of these force-fit approaches are clear, often devolving into an inflexible, sub-optimal process with little ability to scale. This creates considerable overheads in terms of resources, manual effort and cost, while providing poor levels of oversight and compliance.
The business case for a specialist safety reporting solution is therefore very compelling. Automating the business-critical safety document distribution process with an application built specifically for safety document distribution delivers tangible benefits to clinical trial sponsors, including:
pharmasol psiXchange is the only application built specifically for safety document distribution, delivering dramatically improved oversight and control based on stable, cross-validated data relations – from automation to integration.
To learn more about the benefits of intelligent automation of safety reporting, head to the psiXchange section of our website.
We’re very pleased to confirm that both SaaS and dedicated environment customers of our rapidLIVE accelerated deployment solution for Oracle Argus Safety have now been smoothly migrated to Oracle Argus Release 220.127.116.11. We’re also continuing to provide full support to customers who have chosen not to upgrade for now, ensuring that they benefit from seamless support.
The latest Argus release offers several major enhancements, including harnessing the latest browser functionality, and incorporation of the new European Directorate for the Quality of Medicines & HealthCare (EDQM) terminologies for EudraVigilance. As one of the first Oracle Argus Safety pre-packaged solution suppliers to migrate to this latest version, pharmasol is delivering on our mission to help customers everywhere deploy the leading global safety database more quickly and efficiently than ever.
pharmasol’s CEO Torsten Adam and Product Owner for psiXchange Karin van Dort share an exclusive look ahead to the enhanced functionality and major performance updates users can expect from psiXchange version 3.0 when it hits the market next year.
pharmasol’s psiXchange platform for the automated distribution of critical safety documents has been making industry waves ever since its launch. A trusted, gold-standard solution now used by top lifescience organisations across the world, psiXchange enables intelligent safety document distribution to global recipients, and is the only application built specifically for safety document distribution – delivering dramatically improved oversight, control and boosting compliance. The dynamic data alignment and inherent scalability of the psiXchange system means that users can easily distribute tens of thousands of emails daily and smoothly manage all the subsequent follow-up tasks. As the only solution provider exclusively focused on this use case, we are now delivering the highest volumes in the industry and supporting the largest customers globally.
Version 3.0 of the platform – due for release next year – represents a complete revision and thorough upgrade of the psiXchange system, based on pharmasol’s vast experience built across the area of safety document distribution, and incorporating feedback and requests from our valued customers. You shared your ‘wishlist’ with us, and we listened.
Expanded data gathering and global regulatory intelligence
pharmasol’s merger with PharmaLex Group has majorly expanded our global reach and data gathering capabilities. As a result of this expansion, we’re very proud to announce that psiXchange version 3.0 will support significantly more global regulatory intelligence functionality, including providing descriptions of country rules for safety distribution in clinical trials as standard. Users will be able to subscribe to dynamic regulatory requirement updates, and the platform will pre-populate the correct settings per country, gathered from our authoritative sources. For our customers, this new template function removes the need for manual inputting of core data, yet still offers the ability for users to populate or supplement reporting requirements themselves with their own regulatory intelligence.
This new embedded data gathering capability – uniquely powered by PharmaLex – means that we will now be able to pull key regulatory intelligence for over 150 countries, eliminating the requirement for our customers to resource separate teams around the world to scan for this information. It’s a key component of our mission to get software and services working together to drive simplicity and deliver results for our customers.
Safety Central gets more intuitive
A central component of psiXchange version 3.0 is our re-build of Safety Central. For version 3.0, we have developed a completely new, more intuitive site model that better supports local reporting, with the capability for users to send their own submissions to local ethical committees. Another highlight feature of Safety Central is the ability to delegate document acknowledgements. Depending on the processes defined by the clinical trial sponsor, if safety distribution contacts are permitted to acknowledge documents, both the Principal Investigator and the safety distribution contact can now perform that function within Safety Central – meaning that sites always have access to accurate, up-to-date actions. We incorporated this capability in version 2.4, and continue to support the delegation functionality in our newest version.
Searchable Investigator Brochures Library
Another completely novel aspect – not currently offered by any competitive solution – is our new Investigator Brochures (IB) library. Our IB library lists all applicable IBs with subsequent SUSARs, and allows sites to easily perform searches using relevant medical terms (for example “heart attack”). With bulky GAP safety information packs no longer issued as standard, this intuitive feature significantly reduces the administrative burden on investigators.
Enhanced document status tracking
For version 3.0, we’ve further improved users’ ability to track and maintain documents. If documents need to be submitted via courier, or if any other manual action needs to take place, it can now be quickly and easily tracked within the Safety Central information hub. In this way, users can understand the full and accurate status of a document at a glance, aiding oversight and timely submission by the sponsor.
Ramped-up remote site monitoring
The new version of psiXchange will also expand our remote site monitoring capability – seriously reducing the frequency, cost and time burden of physical site visits. Via our platform, CROs or other study team members will be able to seamlessly and virtually explore the status of a site, review any issues, acknowledge documents, pull extended reports, and ensure that all relevant contact information is up-to-date. In the post-COVID world, electronic Investigative Site Files (eISF) and remote monitoring will increasingly be harnessed as less costly and more effective approaches, offering the transparency that is key to successful ongoing oversight and compliance.
Improved contact quality management
Version 3.0 will deliver an improvement in our existing contact management process, with a built-in contact management module that guarantees contact quality via validation controls and error highlighting. The intuitive dashboard will trigger alerts if any area of data isn’t correct – for example, missing and incorrect data, duplication of data, and omitted approval or start dates – and proactively flag to the user anything that is likely to prevent safety document distribution to the central contact.
We’ve also incorporated fully automated email reply management, with automatic email address qualification that removes the need to manually review replies. For distribution lists that can number thousands of recipients, manually checking out of office replies and delivery failures creates a huge administrative burden. As part of our commitment to increasing efficiency and saving our customers time and resources, psiXchange version 3.0 will offer a fully actionable distribution report within the standard dashboard, making reply management quicker, cheaper and more streamlined.
Positioned for success: a single compliance engine, supported by global partners
Our roadmap for the future is for psiXchange to become the central site communication hub – not just for intelligent and aligned distribution of every clinical trial document, but also for required access and information requests from multiple sources. Our vision is for psiXchange to be the single regulatory compliance engine to transparently track both regulatory requirements and intelligence and distribution to contacts – from competent authorities and ethical committees to investigators.
Earlier this year, PharmaLex announced its merger with Phlexglobal, which now provides the wider PharmaLex Group – including pharmasol – with access to Phlexglobal’s industry-leading and innovative electronic Trial Master File platform (PhlexTMF). With pharmasol and the biggest TMF solution provider now playing on the same team, these mergers have created an unrivalled customer-focused solution offering for pharmaceutical organisations – marrying innovative technology with the specialist support and global workforce of PharmaLex.
The team here is incredibly excited to bring you psiXchange version 3.0. Look out for further major announcements soon…
“We’re confident we’re in good hands. We really trust the pharmasol team.”
Lynda Baxter, Vice President, Global Safety Operations, Drug Safety Navigator
For this edition of the newsletter, we spoke with our customer Lynda Baxter, Vice President of Global Safety Operations for pharmacovigilance-specific Clinical Research Organisation Drug Safety Navigator LLC. Lynda shared with us her ambitious plans for the business, and highlighted how DSN team has gained from implementing pharmasol’s accelerated system deployment for Oracle Argus Safety, rapidLIVE.
Based in North Carolina, Drug Safety Navigator provides pharmacovigilance solutions across the full spectrum of drug development and lifecycles – from first-in-human trials all the way through to post-marketing responsibilities and medical information. The company serves a global customer base, with broad reach into Europe, Australia, Japan, China and the wider Asia-Pacific region. DSN’s breadth of geographical reach and flexible service design model is the key to its proven ability to adjust to client needs for specialised drug development, including in the areas of orphan drugs and rare diseases – a major competitive advantage over larger CROs.
DSN works both directly with pharmaceutical clients and with CROs that don’t have safety in-house, as their virtual safety provider – delivering a full range of safety consultation services, including reviewing protocols and labelling, managing aggregate reports, producing GAP analysis audits for relevant SOPs, and ensuring that clients are fully inspection-ready.
Prior to joining DSN in 2016, Lynda worked as a registered nurse for more than twenty years –specialising in critical care and trauma. Lynda then transitioned into the pharmaceutical industry, with currently over 20 years’ experience at both pharmaceutical and CRO companies. A wealth of experience was gained specifically in pharmacovigilance, drug safety, and strategic and tactical safety operations, spanning database management, safety process planning, quality, compliance and training. Together with long-term colleague and Partner and President of DSN, Molly James – who also has an extensive background in nursing – Lynda is now the co-owner of the DSN business.
Q: How did you first come to work with pharmasol?
A: Prior to rapidLIVE, we had successfully implemented Oracle Argus in other companies. When I first joined DSN, the company was using the ArisGlobal safety platform, however, due to the nature of our clients, it was not flexible enough, proving difficult to make customisations and requiring a lot of validation work. So, we began exploring opportunities. My overriding objective was to implement Oracle Argus, since I felt that was the best system to meet our needs.
Molly and I had previously had a very positive experience working with the Quality Director of pharmasol, who had supported a client of ours when we were managing its safety department. So, we connected back with him, and were again impressed by pharmasol’s fundamental understanding of the requirements of the end-user, and the crucial importance of the validation and documentation. Our own quality group went over to Germany and visually inspected the pharmasol operation and were similarly impressed, so we agreed to a contract with pharmasol supporting our servers.
Quite simply, the rapidLIVE package was tremendously impressive. I am still impressed with the package. From my experience of implementing Oracle Argus in several other organisations, the minutiae of making key business decisions during implementation can be extremely inefficient, with those decisions often not made by the best people. What pharmasol was able to provide from their expertise and experience was sound recommendations within the rapidLIVE standard package, with standardised activities, workflows and user roles already pre-identified. The entire process was tremendously streamlined and, crucially, you still retain the ability to make customisations.
In our implementation, pharmasol hosts rapidLIVE for us but we manage the environment for 12 separate enterprises (and growing). Our team oversees the console activities and the end-user change controls, and we liaise with pharmasol to complement and assist with back-end server updates and integrations, which works really well.
Q: What benefits has rapidLIVE delivered within your organisation?
A: As a small CRO, rapidLIVE has significantly improved the efficiency and timelines for implementing upgrades and changes. Our bandwidth is limited, so the ability to minimise the decision-making and activities around those processes is really invaluable. The expertise of the pharmasol team is evident, which establishes trust. Whether it’s a minor dictionary update or a major version upgrade – it’s just much smoother and more efficient.
Q: What’s next for Drug Safety Navigator?
DSN is growing at an exponential rate, and pharmasol is supporting us in that by enabling us to expand into major markets such as China and Japan with competitive enhancements and additional capabilities. The pharmasol team is able to provide expert consultation and guidance on what the processes look like, anticipated timelines and so on, so that we can communicate this clearly to our clients, along with budgets and defined proposals. We definitely value our partnership with pharmasol, and they are continuing to play an important role in the development of our business. We have been through numerous audits and inspections with no safety findings at all. We’re confident that we’re in good hands and we really trust the pharmasol team.
“Quite simply, the rapidLIVE package was tremendously impressive. I am still impressed with the package.”
World Drug Safety Congress Europe 2022 is almost here!
Don't miss your chance to join 700+ thought-leaders as the industry's major players gather together next week to explore the key and emerging challenges within pharmacovigilance and drug safety.
pharmasol's Karin van Dort – Product Owner for psiXchange – will deliver a highlight presentation outlining how organisations can boost efficiency and compliance while lowering costs through safety reporting automation (12.25pm, Tuesday 27th September 2022).
If you'd like to pre-arrange a meeting with our senior team ahead of the show, please just email email@example.com.
See you in Amsterdam!
pharmasol will also be exhibiting and presenting this week at PIPA (Pharmaceutical Information and Pharmacovigilance Association) Conference 2022, from 28th – 29th September in Farnham, UK.
Our IT Director Iain Barnden will be presenting at the event on Thursday 29th September at 9am BST in a session talk entitled “Take control of Safety Reporting through Process Automation” (Track Two). The presentation will look at different approaches to automation, and how these approaches can make a huge difference to user acceptance, compliance and responsiveness.
Iain will be at the pharmasol stand throughout the two-day conference, and on-hand to share how our innovative software and specialist services are streamlining regulatory and operational responsibilities for pharmaceutical and life sciences companies worldwide – reducing costs, boosting efficiency and increasing compliance.
If you'd like to set a time to meet with Iain at the event, please email firstname.lastname@example.org.
We look forward to welcoming you at PIPA 2022!
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