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31st January 2023

pharmasol News: Winter 2023

Welcome to our first quarterly newsletter of 2023!

We hope that your year has started well, and we’re very much looking forward to connecting with you over the coming months, as we put the finishing touches on our industry event calendar for the year. More on that soon...

In this issue, we profile the very latest customers who are the reaping the rewards of implementing our psiXchange and Argus rapidLIVE solutions, including a Spanish clinical pharmacovigilance team that is gaining a major efficiency boost from an integrated PV solution delivered by pharmasol together with PharmaLex.

In our Product Spotlight, we explore two new capabilities recently added to our rapidLIVE solution - an E2B gateway for our SaaS customers, plus the integration of a new, highly-automated new vaccine workflow. Our Industry Deep Dive then takes an in-depth look at the Quest For Quality and how intelligently automating key processes can help to assure good clinical practice in clinical trials, and we round off this issue with a look ahead to the upcoming 31st Pharmacovigilance 2023 event in London next month.

We hope you enjoy our first issue of the new year and, as ever, if you’d like to meet with our experts to discuss optimising your business-critical PV processes, or if you’re interested in a live solution demo, delivered from our team to yours, just reach out to us.

Best regards,

Tim Billington
Chief Sales Officer
+44 118 328 2629

Twitter: @pharmasol
LinkedIn: https://www.linkedin.com/company/pharmasol 

Newsletter contents:

NEWS: AmeriSource Bergen Corporation completes acquisition of PharmaLex

Earlier this month, AmerisourceBergen Corporation (NYSE: ABC) announced the completion of its acquisition of PharmaLex Holding GmbH – pharmasol’s parent company and one of the world’s largest providers of specialised services for the pharma, biotech and medtech industries.

The acquisition of the PharmaLex Group enhances AmerisourceBergen’s growth strategy by advancing its leadership in specialty services and global platform of pharma manufacturer services capabilities. PharmaLex’s regulatory affairs, development consulting and scientific affairs, pharmacovigilance, and quality management and compliance services expand AmerisourceBergen’s role as partner of choice for biopharmaceutical partners across the pharmaceutical development and commercialisation journey.

We’ll be sharing more news about the enhanced capabilities this exciting industry move means for our customers over the coming months but, in the meantime, you can read the formal press announcement here.

Celebrating Customer Success 

Recent rapidLIVE wins

•    A US-based biotech working to help patients with genetic diseases is one of the newest additions to our rapidLIVE SaaS platform for Oracle Argus Safety. Our parent company PharmaLex will be providing additional expert pharmacovigilance support services in this exciting new partnership.

•    An EU Biotech, developing innovative vaccines, is now using pharmasol’s rapidLIVE Oracle Argus Safety SaaS platform to handle case processing for a major COVID-19 product launch. This is delivering significant automation and reporting efficiency gains compared to the customer’s legacy system.

Explore rapidLIVE, our unique deployment approach for Oracle Argus Safety – enabling companies to deploy the leading global safety database quickly and efficiently.
 

Recent psiXchange wins

•    A US-based biopharmaceutical company, with a focus on oncology, is now using our psiXchange system for the intelligent, automated distribution of its business-critical safety documents. This is seamlessly replacing our customer’s existing manual process for Safety Letter Distribution on its pivotal phase 3 Clinical Trials – ensuring streamlined compliance and full tracking oversight.

Discover more about our intelligent, automated business-critical document distribution solution.
 

INTEGRATED SOLUTIONS: pharmasol and PharmaLex partner to boost efficiency for Spanish clinical PV team 

A clinical pharmacovigilance team in Spain is reaping the benefits of an integrated PV solution being delivered in partnership by pharmasol and PharmaLex. The Spanish team – established customers of PharmaLex services – will now be using psiXchange for a customer that has approved psiXchange as its preferred tool to distribute safety letters.

In the long term, the Spanish clinical PV team plans to include psiXchange in all RFPs for new clients as its standard tool for safety letter distributions, having been quick to recognise psiXchange’s potential for saving time and freeing the team to focus instead on addressing potential safety concerns. This ability to measurably reduce the time burden is a crucial advantage, since the administration of safety distributions has historically taken up a significant amount of this team’s time, due to its cumbersome legacy processes involving Excel tables, manually prepared and sent emails, and iterative manual tracking of multiple distribution outcomes (delivered, read and acknowledged).

Following an on-site workshop in Spain in November, where pharmasol experts trained the team on the system and were able to gain a richer understanding of its support and configuration needs, pharmasol has now successfully set up the psiXchange system and it is currently undergoing validation with a view to formal go-live by the end of January.

The Spanish team is hugely excited about the many possibilities offered by the psiXchange platform – which is able to seamlessly manage multiple studies and multiple sponsors – and plans to expand its use across a wide range of customers in the future, sharing its learnings with other international teams within its organisation that have expressed interest in the system. When it comes to best-in-class, integrated PV solutions, teamwork certainly makes the dream work! 
 

PRODUCT SPOTLIGHT: rapidLive - full E2B Gateway integration in SaaS solution, plus new highly-automated vaccine workflow

E2B Gateway now connected in rapidLIVE SaaS

We’re delighted to share that an E2B gateway has now been fully integrated into our rapidLIVE accelerated, pre-packaged SaaS implementation solution for Oracle Argus Safety for this first time. Previously available only to our dedicated environment customers, the fully-compliant gateway is now being offered as standard to pharmasol’s new rapidLIVE SaaS customers. We’ll also be ensuring that our existing SaaS customers have the opportunity to take advantage of this key functionality.

The E2B gateway – a tool that allows direct submission of Individual Case Safety Reports (ICSRs) to regulatory authorities and partners without the need to manually log-in to regulatory agency websites – has been successfully connected in rapidLIVE SaaS, and can be easily set up as an automated process, continuing pharmasol’s drive to deliver greater automation, cost reductions and time savings throughout the pharmacovigilance pathway. As part of our comprehensive support services, and to ensure maximum cost-effectiveness, pharmasol is also able to license to individual endpoints, meaning that your organisation only ever pays for the endpoints that you really need.


rapidLIVE introduces new, highly-automated vaccine workflow  

We’ve also recently introduced into our rapidLIVE solution a new, highly-automated vaccine workflow, to help smooth and speed the reporting process for customers that need to track a high volume of data events, either at the development stage or in post-marketing environments.

This major enhancement was originally driven by the requirements of an existing rapidLIVE SaaS customer that was developing a COVID vaccine (now MAH-approved and in roll-out).  This new intelligent workflow simplifies the processing of data events – such as serious adverse events, lack of efficacy reports, and key post-marketing information – even at very high volumes (10,000+ cases a year).

For customers working in areas such as vaccine development and post-marketing situations with a high volume of safety data, case processing must be as efficient as possible, leveraging press-button automations and configurations that can effectively rationalise the process while ensure optimal compliance.

This intelligent workflow now incorporated into rapidLIVE has been optimised to ensure that individual case studies can be seamlessly moved through all relevant phases – fast-tracked, sent to medical review, reported and archived – at volumes that scale, even in the uniquely challenging situation of rapid global vaccination roll-out that we have seen in the wake of the COVID-19 public health crisis.

To talk to one of our expert team about rapidLIVE, our new high-automated workflow, and to find out more about our support services that can help you quickly register and seamlessly connect to the major reporting agencies – from the EMA, FDA and Health Canada to TGA and MHRA – simply contact info@pharmasol.de.
 

INDUSTRY DEEP DIVE: The Quest for Quality: Ensuring Good Clinical Practice in Clinical Trials 

In this Industry Deep Dive, Karin van Dort, Product Owner - psiXchange, takes an in-depth look at the issue of quality, and ensuring Good Clinical Practice (GCP) in clinical trial environments. Central to any commitment to maintaining data integrity and participant safety through quality guidelines should be a systematic approach to continuous process improvement. This is where intelligently automation and documented quality management across core business processes – such as for safety document distribution – can pay major dividends in terms of delivering valid and compliant outcomes.

Head to our website now for the full article.
 

UPCOMING EVENT: 31st Pharmacovigilance 2023 (1st - 2nd February 2023, London) 

The pharmasol team will be heading to Virtue Insight's 31st Pharmacovigilance 2023 in London next month (1st - 2nd February, Radisson RED London Heathrow). If you're planning on joining the event, drop us a line to set up a meeting.

Our Director of Safety Cheryl James and IT Director Iain Barnden will be attending both days of show, and our Chief Sales Officer Tim Billington will be on site on Day 1, with Director of Sales and Marketing David Judge on hand for Day 2.

To set up a pre-arranged meeting slot, please email info@pharmasol.de. We look forward to seeing you at the show!
 



 

News and events

On-demand Webinar Recording: Improving Safety Reporting Speed and Accuracy with Automation and Embedded Intelligence

22nd February 2024

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PharmaLex newsletter: Autumn 2023

12th October 2023

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PharmaLex Talks podcast - Scaling Patient Safety through Innovation

25th September 2023

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PharmaLex Talks podcast - Safety Reporting Requirements for Marketing in the EU

6th July 2023

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PharmaLex newsletter: Spring 2023

25th May 2023

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The Quest For Quality: Ensuring Good Clinical Practice in Clinical Trials

31st January 2023

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pharmasol News: Winter 2023

31st January 2023

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pharmasol News Round-Up: December 2022

12th December 2022

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Clinical Research Organisation Drug Safety Navigator gains from rapidLIVE’s streamlined flexibility

2nd November 2022

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Upcoming Event: pharmasol at PIPA Conference 2022

14th September 2022

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Upcoming Event: World Drug Safety Europe 2022

14th September 2022

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pharmasol News: Autumn 2022

14th September 2022

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pharmasol News: Summer 2022

19th July 2022

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WEBINAR: rapidLIVE and Oracle Argus – fast-track to the gold standard PV database for life science SMEs

17th May 2022

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RapidLIVE transforms case processing efficiency for award-winning PV service provider IntuVigilance

8th April 2022

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Newsletter – Spring 2022

29th March 2022

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Juggling the regulatory complexities of global clinical trials (pharmamanufacturing.com)

23rd February 2022

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pharmasol completes merger with PharmaLex Group

2nd February 2022

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Automating safety processes can benefit DCTs: Pharmasol (outsourcing-pharma.com)

1st December 2021

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Pharmacovigilance: Improving Public Health – Contract Pharma

23rd November 2021

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pharmasol Launches New psiXchange Capabilities to Enhance Delivery of Clinical Trial Safety Documentation

1st June 2021

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From Signature to Go-live in 6 weeks

10th July 2020

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pharmasol Achieves ISO 27001 Certification

21st April 2020

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Using Third Parties in Business Continuity Plans

6th April 2020

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Business as Usual (at This Unusual Time)

19th March 2020

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Oracle introduced Flexible Code Lists as part of the Argus 8 release

5th February 2020

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New whitepaper – Iterative implementation approach

20th September 2019

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Clarification regarding “Pharmasol Corporation”

1st July 2019

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What’s the most powerful phrase in System Implementation? Why?

22nd May 2019

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Another hosted Argus customer live in record time

8th February 2019

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Right-sizing for Safety Database Implementation

18th January 2019

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How psiXchange and CTM can make your safety reporting life easier!

7th December 2018

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12 months of success for the Argus team

22nd May 2018

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How automation is uncovering hidden insights

30th April 2018

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Coding Of Clinical Data In A World After dsNavigator

18th April 2018

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Release update – March 2018 – Important information for existing customers.

8th March 2018

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What’s a smart portal?

29th January 2018

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APEX success

27th October 2017

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New Strategic psiXchange Deployment with Leading CRO

16th November 2016

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pharmasol Launches Update to Business Process Automation System

16th February 2016

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Investigators’ Experience With Expedited Safety Reports

10th September 2014

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