29th March 2022
A very warm welcome to the launch edition of our brand-new quarterly customer newsletter.
Each issue we’ll be providing exclusive updates on all the latest exciting developments from pharmasol, including recent company news, must-read industry commentary from our experts, success stories from our customers, plus details of our upcoming events and when and where you can meet with our team.
In this first issue, we’ll be exploring proposed changes to UK Safety Reporting and the IRAS’s new feature for combined review, taking a deep dive into the localisation capabilities of our industry-leading automated Safety Document Distribution platform psiXchange, plus hearing from pharmasol customer IntuVigilance about the benefits its team is deriving from our rapidLIVE accelerated deployment solution for Oracle Argus Safety. We hope you enjoy reading.
If you’d like to book a meeting with the pharmasol team to discuss our solutions and how we can help you optimise your business-critical pharmacovigilance processes, please just contact us via the details below.
We look forward to connecting with you soon.
In this newsletter:
NEWS: pharmasol completes merger with PharmaLex
We’re delighted to have formally completed our merger with PharmaLex – one of the world’s largest providers of specialised services for the pharma, biotech and medtech industries. This strategic consolidation brings to the PharmaLex Group our industry-leading SUSAR distribution platform, psiXchange, plus our growing portfolio of full-service pharmacovigilance business support capabilities – extending the solution footprint of PharmaLex’s established Technology-Enabled Smart Services (TESS) division.
“This strategic partnership with PharmaLex is a key milestone in our mission to create a dominant market position and enhance our total solution portfolio offering to our clients. This landmark alliance empowers both organisations to offer greater depth and breadth of service in the fast-growing and highly competitive area of pharmacovigilance – from best-in-class IT solutions, hosting and business process automation to strategic consultancy services.”
pharmasol CEO Torsten Adam
Read the full press release here.
INDUSTRY COMMENTARY: IRAS’s new feature for combined review and consultation on proposed changes to Safety Reporting in UK
In this in-depth Industry Commentary, pharmasol’s Karin van Dort, Product Owner, psiXchange, explores the Integrated Research Application System’s new combined review capability, and its implications for submitting DSURs and Urgent Safety Measures. Karin also summarises the proposed UK changes to Safety Reporting within clinical trials, which are currently in open consultation. Click here to read Karin’s in-depth analysis.
REGULATORY MOVES: EU Clinical Trial Regulation – Ireland’s new NREC-CT form
On January 31st 2022, the EU’s Clinical Trial Regulation took effect, bringing into operation the EU portal and EU database that comprises the new Clinical Trials Information System (CTIS). Access to this new, unified online CTIS portal enables the harmonisation of the submission, assessment and supervision processes for clinical trials throughout the EU. The Regulation – which repeals the previous Clinical Trials Directive – applies directly in all EU Member States and the EEA, replacing the system of different national rules with a harmonised regime across the EU.
There is at least one area within EU clinical trials reporting, however, which leaves room for interpretation by individual countries, and that is in the realm of ethical committee reporting. The EU regulations state that every country can determine whether its local ethical committees deliver some form of reporting. Ireland, for example, has taken up this additional reporting requirement and has produced a new NREC-CT form that must be completed to satisfy its local requirement.
This interesting example of local divergence underlines the importance of having an automated safety document distribution platform that can smoothly accommodate localisation and which provides a transparent, controlled and audited process for regulatory reporting. For more information about how psiXchange’s dynamic reporting capabilities streamline processes, reduce cost and boost compliance, head to https://www.psixchange.com
PRODUCT SPOTLIGHT: psiXchange – multi-lingual capability
“Safety Central” is the account area where recipients can access the Safety Letters that are sent out via psiXchange – our industry-leading automated Safety Document distribution platform. As well as enabling recipients to receive distributions by email with attachment, fax, courier, or single click secure link, all documents are always available to users here, within a dedicated Study Inbox. In response to customer needs, we have now made this available in additional languages. Our application is built in Oracle APEX version 20.2 and the powerful APEX Translate functionality provides us with the ability to handle this request seamlessly.
A single Oracle database instance with Oracle APEX can support multiple database sessions running concurrently in different languages. This translation is not done ‘on the fly’, but instead stored on the database – hence absolutely no impact on performance. The translations can also be manually entered, allowing for a fully customised experience.
As you can see below, where a user is requesting their one-time passcode using their registered email address, it’s possible to allow for the selection of a preferred language.
Then, within the Study Inbox, the recipient can now see all labels in the nominated language.
This is a great collaborative solution for customers that will become a standard part of all future psiXchange releases.
ROADMAP UPDATE: future psiXchange release – next-generation capabilities
We’re currently hard at work developing cutting-edge functionality for the next release of psiXchange, which will build in over 10 years’ experience of industry-leading SUSAR distribution. The new version, planned to be available later this year, will incorporate enhanced capabilities driven by customer needs and our expert insight into future requirements, including:
We’ll be providing more information in our next newsletter – keep an eye out for further updates!
“rapidLIVE has improved our efficiency in case processing by miles.”
Nimisha Kotecha, Managing Director, IntuVigilance
We recently spoke with our customer Nimisha Kotecha, Managing Director of award-winning drug safety and pharmacovigilance service provider IntuVigilance Limited about the company’s work, and the benefits the IntuVigilance team is deriving from rapidLIVE – pharmasol’s accelerated system deployment for Oracle Argus Safety.
The company was established 8 years ago by Nimisha Kotecha, who has a background in radiology and over 20 years’ experience in the pharmaceutical industry. IntuVigilance now has offices in UK, Cyprus and Ireland, delivering drug safety and pharmacovigilance services to pharma and biotech companies, Clinical Research Organisations and small consultancies globally – offering expert support to any business that requires drug safety services for clinical trials, PV services for their marketed products, and support to meet QPPV requirements.
Q: How did you first come to work with pharmasol?
A: As a business that offers case processing services, we were formerly using an off-the-shelf safety database. Coming from the industry, however, I have always wanted to implement Argus, as it is the market leader in safety databases. During our ongoing discussions with Oracle, we realised that they had developed a Software-as-a-Service (SaaS) version of Argus that was being made available to SME businesses like ours, and so we immediately got in touch with pharmasol to discuss their rapidLIVE system and how it could support us.
Q: What benefits has rapidLIVE delivered within your organisation?
A: rapidLIVE has not only increased our capacity but has also made us more efficient in case processing. We are delighted to have been able to implement this version of Oracle Argus Safety SaaS ourselves and make it our own. From the beginning, pharmasol has made it incredibly easy to get up and running, providing us with a very strong team to support the implementation. We had very well-managed weekly meetings with a clear plan and schedule for what we could expect at every stage of getting set up. We were up and running within 4 months with a brand-new system, all of our cases migrated and a robust training programme to boot. The entire process was extremely efficient and well project-managed on pharmasol’s side, and we’ve been superbly supported by their team throughout.
Q: What’s next for IntuVigilance?
We’re continually expanding into new territories with our pharmacovigilance services on a regular basis. We are also about to release a software system that will support the industry with its regulatory intelligence collection which includes country-specific regulation to support global PV and drug safety. Our new system will be launched later this month, and we’re looking forward to providing the industry with ready-made, constantly updated information at their fingertips, so that they no longer have to hire dedicated resource or plough through Regulatory Authority websites to find it. So, it’s a very exciting time for us – watch this space!
WEBINAR: rapidLIVE and Oracle Argus – fast-track to the gold standard PV database for life science SMEs
SAVE THE DATE! pharmasol will be co-hosting an exclusive webinar with Oracle Health Sciences on Tuesday May 17th at 10am GMT/11am CET.
This online session will explore how pharmasol’s accelerated SaaS deployment for Oracle Argus Safety – rapidLIVE – can help small and mid-size pharmaceutical companies and CROs implement Oracle’s class-leading PV database in the most efficient and cost-effective way. With many SMEs keen to implement Argus as their PV database but concerned that it may be too complex, expensive and time-consuming to deploy in their organisations, this webinar will show how rapidLIVE makes Argus accessible to all businesses – whatever your company size or budget.
A pharmasol customer will be joining the session to talk about their experience with rapidLIVE and how it has allowed them to deploy Argus in their organisation, plus bust some of the myths and misconceptions about implementation.
Oracle will be providing a key update to webinar attendees on the most recent advances in Argus, and our pharmasol PV experts will outline developments with rapidLIVE itself, and showcase the very latest capabilities of our safety letter distribution application, psiXchange.
A full agenda and invitations will be issued soon, but if you have any questions or would like to pre-register and secure your attendance, please email email@example.com today.
We look forward to seeing you online in May!
IN THE NEWS: Recent press articles featuring pharmasol experts
Bylined article on managing regulatory complexity in global clinical trials by Karin van Dort, Product Owner, psiXchange for Pharma Manufacturing magazine:
Juggling the regulatory complexities of global clinical trials (pharmamanufacturing.com)
Interview in Outsourcing-Pharma with pharmasol’s Karin van Dort, exploring how to tackle the challenges of safety documentation in decentralised trials:
Automating safety processes can benefit DCTs: Pharmasol (outsourcing-pharma.com)
Pharmasol’s John Buchan takes a deep dive into modern pharmacovigilance, the regulatory role in drug safety, plus looks at public health and ADR reporting:
Pharmacovigilance: Improving Public Health – Contract Pharma
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