12th October 2023
PharmaLex newsletter: Autumn 2023
A warm welcome to our Autumn 2023 newsletter!
We begin this edition by setting out the internal vision that is driving the integrated capabilities now available to customers from our diverse and talented global team of sector experts. Find out why we believe our unified approach to services and technology is ushering in the next frontier in pharmacovigilance innovation.
New for this issue, we are very proud to be sharing a superb edition of the PharmaLex Talks podcast, which takes a fascinating look at the evolution and future capabilities of PV technology and features expert analysis from our very own Cheryl James – Director of Safety Analytics at PharmaLex – and Michael Braun-Boghos, who is Senior Director of Safety Strategy at Oracle. Catch up now with this must-listen episode, ‘Scaling Patient Safety Through Innovation’, at the PharmaLex Talks podcast show page.
You can also read about our latest deployments in our regular Customer Success feature and, in our Product Spotlight, we take a look at a brand-new hero function in psiXchange, psiQ, which offers up-to-date, continuously monitored regulatory intelligence at your team’s fingertips.
Finally, we review one of the highlights of the PV calendar, World Drug Safety Congress Europe, which saw the industry gather in Amsterdam last week for a fascinating few days of insights and discussions.
We hope you enjoy our newsletter. If you’d like to continue the discussion in a one-to-one meeting, or if you’re keen to explore the psiXchange or rapidLIVE solutions in action, just get in touch with us. We look forward to connecting soon.
Commercial Director, PV Digital Solutions
+44 7768 336 302
- Corporate Update
- New Podcast
- Customer Success
- Product Spotlight
- Event Review
CORPORATE UPDATE: Where expertise meets innovation
Tim Billington, Commercial Director of PV Digital Solutions, shares the PharmaLex vision behind the integrated capabilities now available to customers.
When excellence intersects across disciplines, big leaps in capability are possible. At PharmaLex, this integration of best-in-class services with leading technology is foundational to our customer offer. We call this “where expertise meets innovation”.
Innovation is truly in our DNA, and with advanced software and technology-elevated services now working together under our Digital Innovation strategy umbrella, we think PharmaLex is uniquely positioned to help our customers improve compliance, boost the quality of PV operations, and speed time to market.
Within our group, hundreds of experts across our technology and digital services team – from data specialists to IT strategy consultants – are actively collaborating to support our internal platforms and drive development of our SaaS solutions. It’s what differentiates our approach to innovation, and what ultimately drives our vision of revolutionising the life sciences industry – working collaboratively to identity and create transformative opportunities, and developing new ideas and applications based on state-of-the-art technology.
The sheer breadth and deep of core life sciences expertise that we hold in our global team, coupled with our innovative technologies, is delivering elevated business value to our customers today across the industry, wherever they are in the world. We’re committed to making this visible difference, and we hope that you’ll continue to let us know when we succeed.
Meet the PharmaLex management team:
Sébastien Schmitt, Chief Commercial Officer
Bringing over 20 years’ experience in sales, marketing and delivery, with a solid track record in providing tailored service solutions to multi-national clients, Sébastien Schmitt serves at Chief Commercial Officer for PharmaLex Group.
““PharmaLex has shown exceptional leadership in delivering end-to-end product commercialization solutions that span the entire pharma value chain – from discovery to market access. Our experienced global team, with their technical excellence and rich understanding of pharmaceutical lifecycle processes, are highly skilled at drawing together innovative services and technology-elevated solutions to support clients wherever they are in the product lifecycle.
Our unique combination of multidisciplinary expertise and cutting-edge technology-enabled services is enabling us to streamline time-to-market and speed time-to-revenue for clients across the world.”
LISTEN NOW: NEW PODCAST – SCALING PATIENT SAFETY THROUGH INNOVATION
NEW: We’ve very excited to be bringing you this fantastic edition of the ‘PharmaLex Talks’ podcast, ‘Scaling Patient Safety Through Innovation’.
We’ve brought together two leading experts – Cheryl James, Director of Safety Analytics at PharmaLex, and Michael Braun-Boghos, Senior Director of Safety Strategy at Oracle – to discuss the evolution of PV through the decades, and share their views on where innovation needs to focus in the future to ensure that the PV function continues to meet critical needs and also add value.
Cheryl and Michael bring their considerable expertise to bear on how new technology can help life science organisations effectively scale their PV functions to address the continuous rise in adverse event reporting volumes, plus navigate the ever-increasing regulatory requirements and the addition of new data streams.
It’s a fascinating topic, and an illuminating discussion. Listen to it online now.
CELEBRATING CUSTOMER SUCCESS
Recent rapidLIVE wins
- Since our last newsletter, our onboarding team has been busy rolling out our rapidLIVE accelerated deployment solution for Oracle Argus Safety for a raft of new customers. In a highlight project, we have been engaged by a CRO in Italy looking to migrate its entire portfolio of sponsors over to Argus. With the integration almost complete, the rapidLIVE solution is due to go live at the end of this month for our CRO’s first sponsor tenant, closely followed by a further five.
- In parallel, we have also been planning and implementing a 3000+ safety case migration for a major biotech company in the Netherlands. As part of the deployment, we delivered our first on-site training since COVID, which has helped to accelerate ramp-up for our customer. We look forward to a seamless production migration of 3000+ cases from two source systems by October!
- In other exciting developments, our rapidLIVE team has been working on a series of reporting configuration enhancements and product fixes that have now passed validation, so will be rolling out these improvements to our SaaS customer in the coming months.
- Finally, with the release of Argus Safety version 8.4.1 in recent weeks, we’re now hard at work planning the next major upgrade to rapidLIVE Oracle Argus. Do watch this space!
Optimised for Contract Research Organisations, pharmaceutical companies, biotechs and medical device businesses, rapidLIVE is available for the latest version of Oracle Argus – critical for E2B R3 readiness. Learn more.
Highlight psiXchange win
- A leading global CRO will be completing its validation of psiXchange in the coming weeks and will be live in Q4 with the latest system release. Another great win for PharmaLex, and for our customer!
- Hot off the press, another leading global CRO signed for psiXchange in September and will be starting the project in Q4 this year…
For more on our industry-leading psiXchange platform, head to our website and discover how your organisation can dramatically simplify and streamline safety document distribution to sites and relevant authorities.
PRODUCT SPOTLIGHT: psiQ – stay ahead with real-time regulatory intelligence
Did you know that psiXchange now offers real-time, in-platform regulatory intelligence monitoring?
psiQ is a brand-new feature of the psiXchange platform that enables PV teams to access up-to-date and accurate regulatory information for 40 key countries (soon to be expanded to over 130). Harnessing the PharmaLex global team’s expert knowledge of local laws on the ground, psiQ ensures that your PV submissions team are always fully up-to-speed with the current regulatory requirements.
While most databases rely on regular reviews at set intervals, psiQ’s suite of real-time automated monitoring tools rolls out immediate updates so that users always have access to the most current and detailed information on what needs to be reported where and to whom.
What’s more, psiQ doesn’t just provide the raw source data – it interprets the latest updates to deliver clear, actionable information every time. To find out more about the benefits of psiQ and to request a demo, just get in touch with our team.
EVENT REVIEW: World Drug Safety Congress Europe (4th – 5th October 2023, Amsterdam)
Cheryl James (Director of Safety Analytics for PharmaLex) and Iain Barnden (PV Business Partner - Digital Automation) pictured at the PharmaLex stand at World Drug Safety Congress Europe in Amsterdam.
We were delighted to join industry colleagues in Amsterdam last week for one of the highlights of the PV calendar – World Drug Safety Congress Europe.
Our stand was bustling throughout the event, as our senior team shared with delegates the gains of automating and optimising business-critical PV processes. Uptake of our live demos was high, with attendees keen to explore our industry-leading psiXchange solution for intelligent automated safety document distribution, plus enjoy an expert introduction to rapidLIVE - our accelerated pre-packaged implementation for Oracle Argus.
At the conference, discussion of AI and automation dominated the agenda on case processing topics. PharmaLex's Iain Barnden (PV Business Partner - Digital Automation) delivered a well-attended presentation that offered unique insights into how organisations can manage safety reporting complexity at scale through intelligent automation – including how even simple automations can lead to major efficiency gains in case processing, document distribution, literature surveillance and more.
Thanks to everyone who came by our booth and, if you missed us at the show, just email firstname.lastname@example.org to request a meeting or an online demo for your team.