NEWS – New PrimeVigilance Learning Pharmacovigilance Webinar


In this webinar, our expert speakers Dr. Marcela Fialova and Dr. Jana Hyankova will aim to present and provide our listeners with a good understanding of Brexit’s impact on EU and UK pharmacovigilance processes, highlighting the challenges for the Pharmaceutical Industry and the critical requirements that could arise.  


This webinar will run in 2 sessions:

Session 1: 28 January, 10am EST / 3pm GMT / 4pm CET
Session 2: 28 January, 2pm EST / 7pm GMT / 8pm CET

Key learnings include:

Overview of the new pharmacovigilance post Brexit regulation  
•    What are the applicable impacts within the EU for the global pharma company
               • UK QPPV
               • UK PSMF
               • PV Procedures
               • Submission
               • Registering to make submissions to MHRA
•    How to maintain consistency

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

About our expert speakers:

Marcela Fialova, MD – PrimeVigilance, Senior Director, EU QPPV, UK QPPV

Marcela is a pharmacovigilance professional with more than 20 years of experience in the pharmaceutical business. She has spent the majority of this time in pharmacovigilance, as well as quality assurance, auditing and regulatory affairs. For more information, please visit Marcela’s profile on our website.


Jana Hyankova, MD – PrimeVigilance, Director, EU QPPV, UK QPPV

Jana is an expert in pharmacovigilance, with more than 15 years of experience at several global pharma companies. She has worked at PrimeVigilance since 2014, plus additionally serves as EU QPPV for several clients and conducts PV audits as requested by clients. For more information, please visit Jana’s profile on our website. 

If you have any questions  about our webinar please feel free to contact us 

PRESS RELEASE – Ergomed acquires MedSource, a US-based specialist oncology and rare disease CRO

ERGOMED PRESS RELEASE

 

  • Further expansion of Ergomed’s presence in the strategically important US market
  • MedSource’s complementary capabilities in oncology and rare disease build on Ergomed’s internationally recognised specialist expertise
  • Addition of over 20 new clients to the CRO business with over $41 million order book of future contracted revenue
  • MedSource recorded $19.3 million service fee revenue and $1.3 million adjusted EBITDA in 2019
  • Acquisition expected to be immediately accretive and earnings enhancing

Guildford, UK – 14 December 2020: Ergomed plc (LSE: ERGO) (“Ergomed” or the “Company”), a company focused on providing specialised services to the pharmaceutical industry, today announces the acquisition of MS Clinical Services, LLC (“MedSource”), a specialised clinical research organisation (CRO) based in Houston, Texas, USA.
Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: “We are delighted to have delivered on our strategic goals in 2020 with the expansion of our US footprint in both the CRO and PV businesses. The addition of MedSource and its complementary expertise in oncology and rare disease will further establish Ergomed as a specialised services provider in the strategically important US market, building on the successful acquisition and integration of Ashfield Pharmacovigilance (now PrimeVigilance USA) earlier this year. We look forward to developing the potential of this new business to offer truly global clinical research services to our international customer base. We are excited to welcome the MedSource team to Ergomed and are eager to work alongside our new colleagues to leverage our combined expertise in complex therapeutic areas for the benefit of our clients and patients worldwide. Looking ahead to 2021 we expect to see continued momentum across the business as we look to increase our footprint in key geographies, and firmly establish Ergomed as a leading global provider of specialist services to the pharmaceutical industry.”
Eric Lund, founder of MedSource who will continue in his current role as President of MedSource after the acquisition, said: “I am delighted to be joining the Ergomed Group and continuing my current role. We are confident that this is an important strategic step and natural fit for MedSource, as Ergomed is an exciting, fast-growing global company with a strong reputation in the CRO industry. Our own extensive experience in oncology and rare disease drug development and across product types, clinical trial phases and study designs will complement the services already offered to Ergomed’s international client base. The combined business will be of great benefit to our US clients and employees, providing a seamless service offering into Europe and globally.”

Acquisition benefits
MedSource is a full-service CRO with a focus on complex diseases and study designs. MedSource delivers high-quality clinical trials specialising in oncology and rare disease. With over 20 years’ experience, MedSource has participated in more than 200 oncology and rare disease clinical trials.
The acquisition aligns with Ergomed’s strategy to grow its existing profitable services business both organically and through acquisition and advances a number of important strategic objectives for Ergomed, including:
Complementary specialism in oncology and rare disease. The two businesses have core expertise in complex disease areas. The combined business will enable an even greater degree of specialist expertise in high growth sectors of the overall pharmaceutical services market in which Ergomed specialises.
Expanded US presence. The acquisition will further accelerate Ergomed’s growth in the North American market, with additional offices in Houston, Raleigh and Boston in the USA, and Newcastle upon Tyne in the UK. The increased US presence, with the addition of over 110 US-based employees, is expected to drive substantial new awards in the region and increase Ergomed’s pipeline in both the CRO and PV businesses.
Significantly increases Ergomed’s order book. MedSource joins Ergomed with an existing order book of over $41 million, adding to Ergomed’s £151.4 million order book as reported in September 2020 in its H1 2020 interim results, providing high forward visibility of contracted future revenue.
Acquisition terms and MedSource trading history
Under the terms of the equity purchase agreement (the “EPA”), Ergomed has acquired MedSource for an initial consideration comprising $16.2 million in cash paid at the closing of the transaction, up to $1.8 million in Ergomed shares to be issued at a price based on the average daily closing price for 30 days preceding the acquisition and within 15 months of the closing of the transaction, subject to reduction for breaches of representations and warranties, and up to a further $7.0 million payable 90% in cash and 10% in shares depending on MedSource’s financial results in the year to 31 December 2021. The EPA includes customary provisions relating to normalised working capital and representations, warranties and indemnities.
The acquisition will be funded using the Company’s existing cash resources without significant depletion of cash available to fund future organic and inorganic growth.
In its financial year ended 31 December 2019, MedSource recorded total revenues of $31.3 million, comprising service fee revenue of $19.3 million and pass-through revenue of $12.0 million. In 2019 adjusted EBITDA was $1.3 million and net assets were $2.6 million.
The transaction is expected to be immediately accretive and earnings enhancing, with further growth and strategic benefits expected in future years.
Webcast and conference call for analysts:
A webcast and conference call for analysts will be held at 1pm GMT on Monday 14th December.
Webcast link: https://edge.media-server.com/mmc/p/a9nxy8n4/
Conference call details
UK Participant Local Dial-In: 0800 279 6619
US Participant International Dial-In: +1 6467 413167
International Dial-In: +44 (0) 2071 928338
Event Plus Passcode: 3755635
A copy of the presentation will be made available on the Ergomed website before the webcast, under Reports and Presentations, here: www.ergomedplc.com/investor-relations/reports-and-presentations/
Enquiries:

Ergomed plc Tel: +44 (0) 1483 402 975
Miroslav Reljanović (Executive Chairman)
Richard Barfield (Chief Financial Officer)
Numis Securities Limited Tel: +44 (0) 20 7260 1000
Freddie Barnfield / Huw Jeremy (Nominated Adviser)
James Black (Broker)
Consilium Strategic Communications – for UK enquiries Tel: +44 (0) 20 3709 5700
Chris Gardner / Sue Stuart ergomed@consilium-comms.com
Matthew Neal / Olivia Manser

 
About Ergomed plc
Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, a full range of high-quality clinical research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR. For further information, visit: www.ergomedplc.com For further information on MedSource, visit: www.medsource.com.

NEWS – New PrimeVigilance Educational Pharmacovigilance Webinar


In this webinar, our expert speakers Dr. Marcela Fialova and Dr. Jana Hyankova, will aim to present and provide our listeners with a good understanding of the Pharmacovigilance System Master File (PSMF), within and outside the EU, highlighting the challenges for the Pharmaceutical Industry and the critical requirements that could arise.


This webinar will run in 2 sessions:

Session 1: 15 September, 10am EDT / 3pm BST / 4pm CEST
Session 2: 15 September, 2pm EDT / 7pm BST / 8pm CEST

Key learnings include:

• Overview of the different aspects of PSMF set-up and maintenance in a global pharma company
• What types of PSMFs are applicable within the EU
• Descriptions of PV systems in non-EU regions
• How to maintain consistency between individual PSMFs/Descriptions of PV systems required in respective regions

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

About our expert speakers:

Marcela Fialova, MD – PrimeVigilance, Senior Director, EEA QPPV

Marcela is a pharmacovigilance professional with more than 20 years of experience in the pharmaceutical business. She has spent the majority of this time in pharmacovigilance, as well as quality assurance, auditing, and regulatory affairs. For more information, please visit Marcela’s profile on our website.


Jana Hyankova, MD – PrimeVigilance, Director, EEA QPPV

Jana is an expert in pharmacovigilance, with more than 15 years of experience at several global pharma companies. She has worked at PrimeVigilance since 2014, plus additionally serves as EU QPPV for several clients and conducts PV audits as requested by clients. For more information, please visit Jana’s profile on our website. 

If you have any questions  about our webinar please feel free to contact us 

Press Release – Ergomed plc Interim results for the six months ended 30 June 2020

ERGOMED PRESS RELEASE

 
Services strategy drives revenue and profit growth
Order book growth underpins high forward visibility

  • Total revenue growth of 14.8%
  • Service fee revenue growth of 25.9% (18.0% on a like-for-like basis)
  • Adjusted EBITDA £9.1 million up 40.0%
  • Order book up 22.0% since 1 January 2020 providing high visibility into H2 2020 and beyond
  • Strong net cash balance of £14.1 million

Guildford, UK – 22 September 2020: Ergomed plc, (LSE: ERGO) (‘Ergomed’ or the ‘Company’), a company focused on providing specialised services to the global pharmaceutical industry, announces its interim results for the six months ended 30 June 2020.
Financial Summary

First Half 2020 First Half 2019 % change
Figures in £ millions, unless otherwise stated
Total Revenue 40.4 35.2 14.8
Service Fee Revenue  36.9 29.3 25.9
Like-for-like Service Fee Revenue (Note 1) 32.7   27.7   18.0
Gross Profit 18.5 14.5 27.6
Gross Margin (%) 45.8% 41.2%
Adjusted EBITDA (Note 2) 9.1 6.5 40.0
Net cash at 30 June 14.1 8.1 74.1
Order book at 30 June 151.4 118.3 28.0
Basic adjusted earnings per share (pence) (Note 3) 11.3p 9.6p 17.7

Notes:
(1) Like-for-like Service Fee revenue excludes H1 2020 revenues of £4.2m in PrimeVigilance USA Inc acquired on 10 January 2020 and H1 2019 revenues of £1.6m arising from exceptional change orders.
(2) Adjusted EBITDA is defined as operating profit for the period plus depreciation and amortisation, share-based payment charge, acquisition related consideration and costs and exceptional items, less one-off receipts in the period comprising a prior year R&D tax credit and COVID-19 grants (Note 7 to the financial statements).
(3) Basic adjusted earnings per share is defined as earnings per share after adjustment for items referred to in Note 3 to the financial statements.
Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: “Ergomed has delivered exceptional progress both operationally and financially during the first half of the year, continuing to demonstrate our ability to drive sustained growth through a clear focus on our service model strategy. We responded robustly to the challenges of the COVID-19 pandemic with strong revenue and profit growth, a growing order book and sales momentum across the business. We will continue to invest for organic growth and efficiency, with a disciplined approach to strategic acquisition opportunities, and are firmly positioned to realise our potential as a leading global provider of specialist services to the pharmaceutical industry.”
Key Financial Highlights

  • Revenue of £4 million, up 14.8% (H1 2019: £35.2 million)
  • Adjusted EBITDA of £1 million, up 40.0% (H1 2019: £6.5 million)
  • Basic adjusted earnings per share of 11.3p (H1 2019: 9.6p)
  • Net cash of £1 million after £8.1 million acquisition costs paid in cash in H1 2020 (30 June 2019: £8.1 million)

Operational Highlights

  • Robust sales performance with net new awards up 22.9%
  • Order book of future contracted revenue up 28.0% to £4 million (30 June 2019: £118.3 million)
  • PrimeVigilance revenues up 62.1% including major new awards and renewals
    • PrimeVigilance USA business now fully integrated
  • Significant new clinical trial awards including COVID-19 related studies
  • North America revenues up 79.3%
  • Overall resilient response to COVID-19 challenges

Webcast and conference call for analysts:
A webcast and conference call for analysts will be held at 9.00am BST on 22 September 2020.
Webcast link: https://www.lsegissuerservices.com/spark/Ergomed/events/c9f781ec-c803-4029-87ac-1e0a87289ac9
Conference call details
UK Participant Local Dial-In: (0) 20 3107 0289
US Participant International Dial-In: +1 (918) 922-6506
International Dial-In: +44 (0) 80 0028 8438
Conference ID: 7053179
Enquiries:

Ergomed plc  Tel: +44 (0) 1483 402 975
Miroslav Reljanović (Executive Chairman)
Richard Barfield (Chief Financial Officer)
Numis Securities Limited Tel: +44 (0) 20 7260 1000
Freddie Barnfield / Huw Jeremy (Nominated Adviser)
James Black (Broker)
Consilium Strategic Communications – for UK enquiries Tel: +44 (0) 20 3709 5700
Chris Gardner / Sue Stuart ergomed@consilium-comms.com
Olivia Manser / Lizzie Seeley

 
Please find the rest of the interim results on Investors – Reports and Presentations page.
About Ergomed plc
Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing, profitable services business includes an industry leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, a full range of high-quality clinical research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR. For further information, visit: https://ergomedplc.com.
Forward-looking Statements
Certain statements contained within the announcement are forward-looking statements and are based on current expectations, estimates and projections about the potential results of Ergomed plc (“Ergomed”) and the industry and markets in which Ergomed operates, the Directors’ beliefs and assumptions made by the Directors. Words such as “expects”, “anticipates”, “should”, “intends”, “plans”, “believes”, “seeks”, “estimates”, “projects”, “pipeline” and variations of such words and similar expressions are intended to identify such forward-looking statements and expectations. These statements are not guarantees of future performance or the ability to identify and consummate investments and involve certain risks, uncertainties, outcomes of negotiations and due diligence and assumptions that are difficult to predict, qualify or quantify. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements or expectations. Among the factors that could cause actual results to differ materially are: the general economic climate, competition, interest rate levels, loss of key personnel, the result of legal and commercial due diligence, the availability of financing on acceptable terms and changes in the legal or regulatory environment.
These forward-looking statements speak only as of the date of this announcement. Ergomed expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in Ergomed’s expectations with regard thereto, any new information or any change in events, conditions or circumstances on which any such statements are based, unless required to do so by law or any appropriate regulatory authority.

News – Our experts invited to speak at PIPA Conference 2020

The event will take place on Monday, September 28th – Thursday, October 1st
The Venue is an Online Virtual Conference.

Jana Hyankova, PrimeVigilance Head of PV Systems & Regulatory Intelligence Department/PV Director, will have a workshop titled: “Pharmacovigilance Systems Master File Within and Outside the EU”, taking place on Thursday, October 1st from 1.30 – 3.30 PM

Her workshop will cover:
• A short presentation on the legislative background
• A discussion on how to compile PV system description in different regions
• A workshop on the compilation of Central PSMF vs. Country/Region-specific PSMF

Seema Patel, PrimeVigilance Associate Director of Medical Information, will have her speaking session on the topic: “Medical Information for Patients” on October 1st from 4.00 – 5.00 PM.

Her topic will cover:

• With the vast array of information available to patients in this digital era, how can we help bridge gaps in understanding and improve patient literacy.

• This presentation will explore the role which Medical Information teams can play in empowering patients with the right information, using the right tools from a US and UK patient perspective.

If you have any questions please write to us at info@primevigilance.com 

About the PIPA event:

The 2020 PIPA Virtual Conference provides a comprehensive and cost-effective learning and training opportunity for Medical Information, Pharmacovigilance and Code & Compliance professionals of all levels, including managers.
PIPA (Pharmaceutical Information & Pharmacovigilance Association) is a membership association for professionals working within the fields of medical information, pharmacovigilance and related functions in the pharmaceutical industry. PIPA provides training, events, guidance, resources and networking opportunities to assist our members in their roles.
For more information on PIPA, the conference itself, to register and to see the programme, please visit their website: https://pipaonline.org/

#MedicalInformation, #Pharmacovigilance a #Code&Compliance #drugsafety

NEWS – COVID-19 Pharmacovigilance Support Webinar: How to Adapt Hosting, Conduction of Remote Audits and Inspections

 

In this webinar, our expert Ejaz Butt, PrimeVigilance Director of Audit Management, will share his experience on how PrimeVigilance has been adapting audits and inspections during the challenging period of COVID-19 with its pitfalls, perils and possibilities.

This webinar will run in 2 sessions:

Session 1: 30 June, 10am EDT / 3pm BST / 4pm CET

Session 2: 30 June, 2pm EDT / 7pm BST / 8pm CET

Remote audits and inspections have always played an important role in Quality Assurance and Pharmacovigilance. In the past few months of the pandemic, remote work has become a key consideration; audits and inspections have taken on more importance than ever before.

In this webinar Ejaz will be covering some of the following topics:

  • The various legislative and regulatory thoughts around this practice, discussing the challenges of either conducting or hosting remote audits and inspections
  • How does PrimeVigilance prepare?
  • What considerations need to be taken into account?
  • How does PrimeVigilance ensure a successful experience to the best of their capabilities?


About our presenter Ejaz Butt:

Ejaz Butt is the Director of Audit Management at PrimeVigilance, bringing a wealth of Pharmacovigilance and Quality Assurance experience from his Pharmaceutical and Consultancy background. He has over 20 years’ experience in the scientific and healthcare industry, commencing with the UK National Health Service (NHS), through to Academic Research before moving into the pharmaceutical industry and specializing in Pharmacovigilance, working for companies such as 3M Healthcare, Johnson & Johnson and Novartis.

Ejaz has been heavily involved in PV Quality Assurance over the last seven years, focusing on Auditing and has conducted almost 100 audits over this period – around a quarter of which were remotely conducted. Ejaz is also a member of the Research Quality Association (RQA) and is the current President of the Pharmaceutical Information Pharmacovigilance Association.

Press Release – Ergomed H1 2020 Trading Update

ERGOMED PRESS RELEASE

  • EBITDA for FY 2020 expected to be materially ahead of market expectations
  • Integrated pharmaceutical services business demonstrates resilience during Covid-19
  • Total revenue growth of 14.8% over H1 2019; like for like service fee revenue up 18.0% over H1 2019
  • Order book up 22.0% since 1 January 2020 provides high visibility into H2 2020 and beyond
  • Strong cash balance of £14.1 million and debt free

Guildford, UK – 21 July 2020: Ergomed plc, (LSE: ERGO) (“Ergomed” or the “Company”), a company focused on providing specialised services to the pharmaceutical industry, today announces a trading update for the first half of 2020. The Company will provide further details of the first half performance with the publication of its audited interim results in September 2020.
Trading materially ahead of expectations
Building on the robust performance reported at the beginning of the year, Ergomed had an excellent first half, with overall growth in revenue driven by continued demand for its services across the integrated business, despite the global Covid-19 pandemic. Ergomed now expects EBITDA for the year ending 31 December 2020 to be materially ahead of current market expectations.
Total revenues for H1 2020 increased by 14.8% to £40.4 million (H1 2019: £35.2 million). Service fee revenues, excluding revenue from the recently acquired PrimeVigilance USA, pass-through revenues and H1 2019 one-off revenues of £1.6 million relating to change orders and the implementation of IFRS 15, increased by 18.0% over H1 2019.
Revenues in PrimeVigilance, the pharmacovigilance (PV) business, increased by 62.1% to £26.1 million from £16.1 million in H1 2019. The underlying increase was 36.0%, excluding £4.2 million revenues from the now fully integrated PrimeVigilance USA business.
The Contract Research Outsourcing (CRO) business saw its underlying service fee revenue decline 6.7% from £11.9 million in H1 2019 to £11.1 million. Total CRO revenues decreased from £19.0 million in H1 2019 to £14.3 million due to the Covid-19 impact on pass-through revenues and the inclusion in H1 2019 of the £1.6 million one-off revenue uplift referred to above.
Positioned for further growth; high visibility into H2 2020 and beyond
Sales of new business for H1 2020 increased by 22.9% to £60.2 million (H1 2019: £49.0 million), including significant levels of new business from effective cross-selling activities between the CRO and PV businesses. Ergomed won major new contracts for both its CRO and PV services drawing on its expanded geographic territory, including within its newly acquired PrimeVigilance USA client base.
Ergomed’s order book remains healthy at £151.4 million at the end of H1 2020, up 22.0% from £124.1 million at 31 December 2019 and up 28.0% on the prior year (H1 2019: £118.3 million), providing excellent visibility of contracted revenues for the second half of 2020 and beyond.
Cash balances at 30 June 2020 were £14.1 million and the Company continues to be debt free with additional facilities of £30 million available to support expansion.
The continuing sales growth, healthy order book and financing capability position Ergomed firmly for further growth.
Covid-19 update
Ergomed is contributing to the global fight against the Covid-19 virus, becoming a recognised provider of Covid-19 research support and facilitating a number of projects through both its CRO and PV businesses in Europe, North America and Asia. This included the SISCO study at the Papa Giovanni XXIII Hospital in Bergamo, Italy, one of the first major Covid-19 projects globally, which demonstrated Ergomed’s specialist capabilities in successfully managing complex clinical programmes.
At the beginning of the pandemic Ergomed implemented a range of employee safety measures and successfully transferred to a fully remote working operation with no disruption to the business and no redundancies or furloughed staff. The trading results for H1 2020 confirm that despite the Covid-19 crisis, the business maintained its momentum over the second quarter lockdown period, and continued to grow strongly, achieve its sales targets, build its order book and bolster its robust financial platform.
Dr Miroslav Reljanović, Executive Chairman of Ergomed, commented: “Ergomed has delivered exceptional progress both operationally and financially during the first half of the year. We have responded strongly to the challenges of the Covid-19 pandemic, maintaining momentum and improving margins with EBITDA expected to be materially ahead of market expectations for the full year. This excellent performance has strengthened the platform from which to deliver on our strategy to provide specialist services in key market sectors, to invest for organic growth and efficiency, and to make disciplined acquisitions to achieve geographic expansion and drive increased sales and enhanced profitability.”

ENDS

 
Enquiries:

Ergomed plc  Tel: +44 (0) 1483 402 975
Miroslav Reljanović (Executive Chairman)
Richard Barfield (Chief Financial Officer)
Numis Securities Limited Tel: +44 (0) 20 7260 1000
Freddie Barnfield / Huw Jeremy (Nominated Adviser)
James Black (Broker)
Consilium Strategic Communications – for UK enquiries Tel: +44 (0) 20 3709 5700
Chris Gardner / Sue Stuart ergomed@consilium-comms.com
Matthew Neal / Olivia Manser

 
About Ergomed plc
Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing, profitable services business includes an industry leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, a full range of high-quality contract research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR. For further information, visit: http://ergomedplc.com.
 

Press Release – Strategic Collaboration to Drive Pharmacovigilance Leadership in Intelligent Automation

Ergomed plc Press Release

Guildford, UK – 18 May 2020: Ergomed plc (LSE: ERGO) (‘Ergomed’ or the ‘Company’), a company focused on providing specialised services to the pharmaceutical industry, is pleased to announce PrimeVigilance’s strategic collaboration with Automation Anywhere, a global leader in Robotic Process Automation (RPA) and DataRobot, the leader in enterprise artificial intelligence (AI), to accelerate the Company’s Intelligent Automation strategy.

PrimeVigilance, a division of Ergomed, is the leading global specialized provider of full pharmacovigilance (PV) services, and currently employs over 750 people. By empowering its clients and colleagues with the application of RPA and Machine Learning (ML), PrimeVigilance will enable clients to improve quality and consistency within safety databases, as well as productivity.

A successful proof of concept has been completed, and PrimeVigilance will now implement a cloud software solution to automate specific pharmacovigilance processes. The productivity gains made possible by working with Automation Anywhere and DataRobot, are expected to deliver organic growth more efficiently, with the automation of manual, repetitive processes. Automation Anywhere’s cloud-based RPA on its digital workforce platform combined with DataRobot’s enterprise AI platform will bring new levels of speed and intelligence to a crucial component of the business, freeing up valuable hours for highly trained pharmacovigilance professionals to focus on value creation and problem solving that only humans can address.

This strategic partnership will be part of Ergomed’s wider strategy as it transforms the relationship between its people and technology, enhancing the Company’s creativity, agility and skills for the benefit of its clients and shareholders. It will enhance Ergomed’s existing skills and expertise by combining human insight and knowledge with the intelligent application of technology to enhance the speed and precision of analysis and decision making.

Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: “Adoption of the latest available technologies, including automation and robotic technology across our pharmacovigilance business, ensures we are able to continue to offer cutting edge services to our customers. This collaboration provides the foundation to rapidly identify and automate a wide range of business processes, enabling clients to maximise quality and consistency within safety databases as well as increasing productivity.”

Prince Kohli, Chief Technology Officer at Automation Anywhere, commented: “Intelligent Automation can help to unlock valuable human capacity to focus on innovation-led projects, while reducing costs and shortening the time to market. Ergomed understands this opportunity, and we’re excited to be working with them and DataRobot to unleash the potential of Intelligent Automation to enable a better customer experience and faster time to value.”

Automation Anywhere Enterprise A2019, was designed from the ground up as a cloud-native and web-based RPA platform offering lower total cost of ownership (TCO), increased performance and scalability. It combines advanced RPA, artificial intelligence (AI) and embedded analytics, enabling enterprises to digitize business operations, driving scalability, reusability and lowering operating costs. The company’s software bots, which are delivered via the cloud, work side-by-side with human workers to automate repetitive, mundane tasks, freeing up valuable human resources to focus on more meaningful work.
“Companies across all sectors and geographies have learned that they can transform their business by embracing Intelligent Automation,” said Dan Wright, President and COO, DataRobot. “By implementing this technology, companies can combine the best of human and machine intelligence, drive rapid automation and enhanced operational efficiency, and experience exponential returns on their investment. We’re excited to have teamed up with Automation Anywhere to help Ergomed push the boundaries of what’s possible.”

DataRobot is the leader in enterprise AI, delivering trusted AI technology and return on investment (ROI) enablement services to global enterprises competing in today’s Intelligence Revolution. DataRobot’s enterprise AI platform democratizes data science with end-to-end automation for building, deploying, and managing machine learning models.

ENDS

Enquiries:

Ergomed plc Tel: +44 (0) 1483 402 975
Miroslav Reljanović (Executive Chairman)
Richard Barfield (Chief Financial Officer)

Numis Securities Limited Tel: +44 (0) 20 7260 1000
Freddie Barnfield / Huw Jeremy (Nominated Adviser)
James Black (Broker)

Consilium Strategic Communications – for UK enquiries Tel: +44 (0) 20 3709 5700
Chris Gardner / Sue Stuart ergomed@consilium-comms.com
Matthew Neal / Olivia Manser

Automation Anywhere Tel: +44 79 32552473
Kerry Davis Kerry.davis@automationanywhere.com

DataRobot Tel: +1-617-765-4500
Libby Botsford Elizabeth.botsford@datarobot.com

About Ergomed plc

Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing, profitable services business includes an industry leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand, a full range of high-quality contract research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR. For further information, visit: http://ergomedplc.com.

About Automation Anywhere

Automation Anywhere is a global leader in Robotic Process Automation (RPA), empowering customers to automate end-to-end business processes with software bots – digital workers that perform repetitive and manual tasks, resulting in dramatic productivity gains, optimized customer experience and more engaged employees. The company offers the world’s only web-based and cloud-native intelligent automation platform combining RPA, artificial intelligence, machine learning, and analytics right out of the box, to help organizations rapidly start and scale their process automation journey. Its Bot Store is the world’s first and largest marketplace with more than 850 pre-built, intelligent automation solutions. With offices in more than 40 countries and a global network of 1,500 partners, Automation Anywhere has deployed over 1.8 million bots to support some of the world’s largest enterprises across all industries. For additional information, visit www.automationanywhere.com.

About DataRobot

DataRobot is the leader in enterprise AI, delivering trusted AI technology and enablement services to global enterprises competing in today’s Intelligence Revolution. DataRobot’s enterprise AI platform democratizes data science with end-to-end automation for building, deploying, and managing machine learning models. This platform maximizes business value by delivering AI at scale and continuously optimizing performance over time. The company’s proven combination of cutting-edge software and world-class AI implementation, training, and support services, empowers any organization – regardless of size, industry, or resources – to drive better business outcomes with AI.

With a singular focus on AI since its inception, DataRobot has a proven track record of delivering AI with ROI. DataRobot has offices across the globe and $431 million in funding from top-tier firms, including New Enterprise Associates, Sapphire Ventures, Meritech, and DFJ Growth. For more information, visit https://www.datarobot.com, and join the conversation on Twitter and LinkedIn.

Press Release – PrimeVigilance Announces Provision of Clinical Safety Services for COVID-19 Clinical Trial Program

Guildford, UK – 30 March 2020: Ergomed plc (LSE: ERGO) (‘Ergomed’ or the ‘Company’), a company focused on providing specialised services to the pharmaceutical industry, today announces that it will provide drug safety services through its specialist pharmacovigilance provider, PrimeVigilance, for an ongoing US clinical trial to assess the effect of a rheumatoid arthritis treatment on patients with severe COVID-19 infection.

Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: “COVID-19 represents a severe and pressing challenge for all involved in the development of new medicines and we are proud to be expanding our involvement in the field by bringing our expertise in drug safety and pharmacovigilance to this program. The rapid initiation of clinical trials and establishment of appropriate safety monitoring will be critical to providing new treatments which may improve outcomes for patients.”

NEWS – PrimeVigilance response to Zagreb earthquake


Dear Valued Clients, Partners and Industry Colleagues,

In these unprecedented times, all of us have been following, with natural concern, the earthquake that occurred in Zagreb, Croatia early in the morning of 22 March 2020. This is over and above the escalating situation as a result of the Covid-19 global pandemic.
 
PrimeVigilance would like to keep you informed on the necessary steps we are taking to protect the health and safety of our employees and their families, our customers, patients and communities.
 
First of all, we are pleased to say that we have been in contact with our employees and confirmed that they and their families are safe and well.

The vast majority have logged on to their work accounts this morning and are continuing their daily activities. All systems are running within normal parameters, so clients should be reassured that their PrimeVigilance colleagues are safe and that the work continues as normal.
 
The international nature of our business means where necessary we can maintain continuity of our business with support from other offices and regions. These offices, which are based in Europe and the USA, have already begun home working due to Covid – 19, with more than 90% of our employees working remotely with tested, robust technologies in place. This way we ensure the safety of our staff as much as possible, while effectively providing our services to all our clients. As stated, these measures were implemented in response to the COVID-19 pandemic but also serve us in the current situation in Zagreb.

Our offices in Belgrade, Guildford, Prague, Frankfurt, Krakow, Boston and Raleigh, as well as Zagreb, are all standing ready, with spare capacity, to support each other as the need arises. The data center is fully functional and working well, with back-up and recovery plans in place. All our offices work under the PrimeVigilance Business Continuity Plan.

Should you have specific questions, please reach out to your business contact or project manager or via info@primevigilance.com
 
If there are any significant changes to the approach we have taken, we will inform you as appropriate.
 
Thank you for your continued support.

Warm regards,
Jonathan West
President
PrimeVigilance

Contact us:
Global Headquarters
PrimeVigilance Ltd – Head Office
1 Occam Court
Surrey Research Park
Guildford, Surrey
GU2 7HJ
Phone:  +44 (0)1483 307920

USA, Cary, NC Office
100 Regency Forest Drive
Suite 160
Cary, NC 27518 USA
Phone:  (+1) 919-401-8003

info@primevigilance.com
 


 
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