19th July 2022
Welcome to the Summer 2022 edition of our quarterly customer newsletter.
In this issue, we shine a spotlight on the successful update of our rapidLIVE accelerated deployment solution to the latest Oracle Argus Release, plus take a look ahead to the major solution enhancements in store for psiXchange customers when version 2.4.1. is rolled out in the autumn.
Our customer success story this issue focuses on leading global research and development pharmaceutical company Eisai, and explores how psiXchange has transformed its regulatory intelligence management. Finally, we preview our presence at this year’s World Drug Safety Congress Europe 2022 (27-29 September 2022, Amsterdam), where Karin van Dort, pharmasol's Product Owner for psiXchange, will be an invited speaker.
We hope you enjoy reading and, as ever, please share your comments and questions with us here or via our social channels – we’d love to hear from you.
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, please just get in touch.
We look forward to connecting with you soon.
Chief Sales Officer
In this newsletter:
In January, PharmaLex Group announced the completion of its latest merger, having joined forces with leading technology and services organisation for clinical and regulatory solutions Phlexglobal.
Phlexglobal provides its industry-leading and innovative electronic Trial Master File platform (PhlexTMF) and services to hundreds of global life sciences companies, plus AI-enabled automation solutions that allow customers to benefit from existing clinical and regulatory training models.
Phlexglobal’s staff of more than 400 people – based in the UK, US, India, Poland and Germany – bring their highly valued technical skills and established market footprint to the wider PharmaLex Group, which includes pharmasol. 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.
“We are delighted to welcome the Phlexglobal team to the PharmaLex Group, and the opportunity to continue our commitment to innovation by further expanding our technology-enabled service solutions portfolio with the addition of Phlexglobal’s capabilities for eTMF technology and services, as well as their state-of-the-art regulatory operations and automation technologies. The merger enables us to further our goal of becoming a technology-enabled solution provider, and at the same time increasing operational excellence and efficiency through our global subject matter expertise.”
PharmaLex CEO Dr. Thomas Dobmeyer
Read the full press release here.
We’re delighted to share that our rapidLIVE accelerated deployment solution for Oracle Argus Safety has now been updated to Oracle Argus Release 22.214.171.124 (https://docs.oracle.com/en/industries/health-sciences/argus-safety/126.96.36.199/index.html) . All of our rapidLIVE Argus SaaS customers and the first of our dedicated Argus environment customers successfully moved to the new version over the past month. Alongside further dedicated customer upgrades over the summer, we are also fully supporting those hosted and on-premise customers who have chosen not to upgrade at this time, providing them with a solution that keeps them seamlessly supported.
This latest Argus release also takes advantage of the more modern browser functionality (including Chrome and Edge), moving away from the Internet Explorer dependency.
The new Oracle Argus release incorporates the new European Directorate for the Quality of Medicines & HealthCare (EDQM) terminologies for EudraVigilance – the EMA-operated system for managing and analysing information on suspected adverse reactions to medicines that have been authorised or are being studied in clinical trials in the European Economic Area. pharmasol is delivering additional value by providing an ongoing maintenance service to regularly update these terminology listings – including via a custom tool we have developed to retrieve the terms from EDQM.
Two key areas of interest within the EudraVigilance regulatory update – which came into force on 30^th June 2022 – and now reflected within the latest Oracle release include changes to:
From 30^th June, EudraVigilance will also no longer accept case reporting within the E2B(R2) format, moving to E2B(R3) only.
The move to Oracle Argus 188.8.131.52 represents a major technical as well as a functional upgrade for our rapidLIVE solution. With virtually every element updated – from the version of the servers that host the application and databases, through to an upgrade and validation of the entire database and application – we’re proud to be one of the very first Oracle Argus Safety pre-packaged solution suppliers to migrate to the new version, and to be able to bring its benefits to pharmasol customers.
Our very first customer to migrate to version 184.108.40.206 was North Carolina-based pharmacovigilance specialist Drug Safety Navigator, which successfully went live on 18^th June 2022. Lynda Baxter, Vice President, Global Safety Operations, Drug Safety Navigator, comments: “DSN is delighted to be one of the first pharmasol customers to go live with Oracle Argus version 220.127.116.11, which enables us to be continuously compliant with the latest EDQM terminologies and required formats.”
pharmasol’s unique deployment approach for Oracle Argus Safety is enabling companies around the world to deploy the leading global safety database quickly and efficiently. Combining faster time-to-go-live with reduced costs, rapidLIVE is currently hosted for many of the top global pharmaceutical companies and CROs. With this smooth and speedy upgrade to Oracle Argus Release 18.104.22.168, we are demonstrating, once again, our commitment to providing streamlined access to the industry-leading safety database in the most timely, flexible and convenient way possible.
Hot on the heels of psiXchange 2.4 – currently in roll-out – we’re already getting set to on-board customers to version 2.4.1, the next update of our industry-leading platform for the automated distribution of critical safety documents.
Development work on psiXchange version 2.4.1 is complete, and we plan to begin rolling out the new version to customers straight after the summer. Major solution enhancements in the new version will include:
Driving the psiXchange platform roadmap is our ambition to provide customers with the most user-friendly, easy to access reports possible – offering pre-filtered information, improved graphical data presentations and fully downloadable charts that provide a clear, comprehensive, at-a-glance overview of a site’s status and performance. Within the Clinical Trial Management module, version 2.4.1 offers a broad range of enhanced reports such as Regulatory Compliance, Site Responsiveness and Reporting Requirements, the ability to set “report view” preferences, tailored to the specific wishes of the clinical trial sponsor.
For end users, the 2.4 Site View has added the ability for everyone at the site to view the same message, providing ultimate transparency and real-time data sharing. CRAs are also able to access additional info, such as contact data and key information on how the site is performing, enabling CRAs to easily correct errors and follow-up remotely, without the need for a physical visit.
In our Safety Central smart portal, depending on the level of access privilege, users can download and acknowledge information, plus access historical data. In “CRA View”, users can pre-filter on “Planned Sites” or “Closed Sites”, check the Site Inbox, and seamlessly survey Distribution Reports, Sponsor Actions and Contact Overviews, enabling CRAs to immediately check whether the information for each site is correct.
psiXchange 2.4.1 also sees the inclusion of NREC standard local forms for Ireland, as well as the NRES form for the UK, and we have modified our Single Case Report and Aggregate Report forms to provide better guidance on what information needs to be entered where within each section.
Finally, our newest versions add standard, targeted distribution – allowing you to send any document irrespective of reporting requirements. So, if you have a one-off document or urgent safety issue that impacts everyone involved in the study, psiXchange users now have the ability to swiftly distribute a document to all investigators within a standardised format, requiring minimal manual adaptation.
With our psiXchange platform development programme, we are continuously innovating to meet the evolving needs of our customers – supporting the move towards increasing remote monitoring, and the standardisation and pre-formatting and validation of reports. Our mission is to deliver industry-standard templates for the distribution of every document type – from SUSAR to general safety distribution and beyond – and to save our customers time and money while measurably improving their compliance.
Version 2.4.1 represents another big delivery milestone on our roadmap, and we’re looking forward to sharing news of another big step – psiXchange version 3.0 – in our next issue.
“The way that the psiXchange system manages regulatory intelligence provides a level of detail that other vendors simply don’t offer.”
Valerie Bartlett, Associate Director – Clinical Safety Alert Reporting, Eisai
For this issue, we were pleased to speak with Valerie Bartlett, Associate Director, and Silvia Machado, Associate, of the Clinical Safety Alert Reporting team at our customer Eisai (https://www.eisai.com/) . We discussed the advantages that the Safety Alert Reporting team at Eisai has gained from using pharmasol’s psiXchange platform – the only software developed exclusively for the business-critical process of automated safety letter distribution.
Eisai is a leading global research and development pharmaceutical company headquartered in Japan. The company’s corporate mission is "giving first thought to patients and their families and to increasing the benefits health care provides”, which Eisai calls its “human health care (hhc) philosophy.” The company employs around 11,000 people working across its worldwide network of R&D facilities, manufacturing sites and marketing subsidiaries, globally tasked with delivering innovative products to address unmet medical needs, with a strategic focus on oncology and neurology.
Founded in 1941, Eisai now has regional offices and a network of best-of-breed global affiliates across Europe, the Americas and Asia and Oceania. Valerie and Silvia are based at Eisai Inc.’s office in New Jersey in the United States. Valerie, who holds an MBA from Thomas Edison State University, has been with the company for over 10 years. As Associate Director of Global Regulatory Clinical Service (Safety Alert Reporting), Valerie oversees and manages the Safety Alert Reporting team and processes, and is responsible for delivering the global SUSAR and IND Safety Alert Reporting, 6-Monthly Line Listings, DSURs, IND Aggregate Reports, and non-Clinical safety letters globally – ensuring high quality and timeliness while adhering to local reporting requirements.
Silvia Machado holds a BA in Justice Studies from Montclair State University and has worked in Eisai’s Global Regulatory Clinical Services team since 2019.
Q: How did you first come to work with pharmasol?
A: The decision to work with pharmasol was based on our regulatory intelligence needs. Previously, we had a home-grown database, which we tried to evolve, but it was always cumbersome – requiring a high degree of manual effort to maintain. So, we were looking for a solution that could automate as much of the relevant processes as possible, and efficiently manage distributions to our contacts.
I’d first been aware of pharmasol when the company was fairly new (in around 2014). At that time, we were staying with our internal system. When we came to look at the market again and conducted an industry scan, we were really impressed with the developments and enhancements that pharmasol had made to the psiXchange solution. We started migrating small studies to the platform, and then we worked to incorporate own business processes and needs. The pharmasol team was excellent throughout, addressing any issues swiftly and supporting us to programme our own needs on top of industry standards. We’ve appreciated the personalised and very responsive customer service from our pharmasol account team.
Q: What benefits has the psiXchange platform delivered within your organisation?
A: The way that the psiXchange system manages regulatory intelligence provides a level of detail that other vendors simply don’t offer. It’s important to our business to have granular details and psiXchange provides that granularity. It’s not a one-size-fits-all package, and we can fully customise our reports, telling the system exactly what output we want. Therefore, we can specify precisely what information we need to pull out and get the information quickly out of the system in an aggregated form. As a result, the manual effort required from my team has now been significantly reduced, and we’re confident that the system is pulling in the right recipients every time.
One of our key measures is productivity in our input. It’s important for our team to get a high volume of reports out, and any solution needs to manage and keep up with our demands, and deliver an improvement over what we were doing. psiXchange very much delivers that.
We’ve been getting great feedback from end-users and stakeholders, who similarly want the easiest solution possible. Continuing to ensure user satisfaction is my goal moving forward. This is an evolving industry with changing regulations, so keeping compliance up while making sure the end user is happy with their experience is an ongoing challenge that psiXchange is helping us to achieve.
pharmasol has a strong reputation for assessing customer needs and creating future upgrades that will meet those needs, so we’re looking ahead to implementing the 2.4.1 version.
SAVE THE DATE! Karin van Dort, pharmasol's Product Owner for psiXchange, will be an invited speaker at World Drug Safety Congress Europe 2022 (27-29 September 2022, Amsterdam).
Karin will be presenting her key session – 'Take Control of Safety Letter Distribution through Process Automation' – at 12.45 on Tuesday 27th September.
pharmasol is a key sponsor of the event, and will be exhibiting at stand 30 throughout the conference, so please do drop by to explore our specialist software and full-service solutions, and discover how pharmasol is successfully optimising business-critical pharmacovigilance processes for the life sciences industry.
If you'd like to pre-arrange a meeting with our senior team ahead of the show, please just email firstname.lastname@example.org.
We look forward to seeing you in Amsterdam in September!
For more information about the event and to register, please visit: http://ow.ly/apVi50JkL5f
Q: Are you being told that Oracle Argus is too complex, expensive and time-consuming to deploy?
Q: Have you been told that your minimum number of cases is too low to consider Argus?
Q: Does automating the distribution of safety documents to reduce manual activities sound too good to be true?
A: Think again. Think two words: think rapidLIVE, think psiXchange.
HEAR first-hand how pharmasol's rapidLIVE accelerated SaaS deployment for Oracle Argus Safety makes the industry-standard safety database accessible and cost-effective – whatever your company size or budget.
LEARN how you can successfully automate document distribution with pharmasol’s psiXchange, streamlining your costs and efforts and minimise the potential for human error.
EXPLORE the very latest features and updates in Oracle Argus Safety.
Our exclusive webinar – now available on demand – features authoritative insights from industry experts, including rapidLIVE customer Nimisha Kotecha (Managing Director of IntuVigilance), Cheryl James (Director of Safety for pharmasol) and Philip Sheridan (Business Development Director for Oracle Health Sciences).
Register to access this on-demand webinar today: On-Demand Webinar (oracle.com)
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