Author: devadmin2

Sally has a proven track record in driving transformational changes and delivering business results in highly regulated environments across Pharma, Biotech, and CRO industries. She is a people-first leader, with an unwavering commitment to quality and innovation. She is adept at building diverse and inclusive, high-performing teams. Her strength of leadership places PrimeVigilance in a commanding position to further augment its market share.
Sally shared:” I am delighted to be part of PrimeVigilance’s continued success during this dynamic period of growth. I look forward to strengthening our client partnership in our endeavour to remain the leading pharmacovigilance service provider.”
Sally is always thinking about our customers and innovative solutions that will exceed their expectations today and in the future. This combination of a growth mindset and strength of leadership will help lead PrimeVigilance forward.
Please, join us in wishing Sally the very best in her new role!
 

This webinar series aims for our experts to present and provide our listeners with a good understanding of the overall Pharmacovigilance System. Our first webinar will guide you through Pharmacovigilance Agreements (PVAs), helping our listeners have the knowledge and support they would need to avoid any challenges that could arise.

Choose between one of 2 sessions available for this webinar:

• Session 1: 21 July, 10am EST / 3pm GMT / 4pm CET
• Session 2: 21 July, 2pm EST / 7pm GMT / 8pm CET

Key learnings include:

• Introduction of the legislative background
• Description of the PV agreement life cycle
• Overview of different types of PV agreements
• An in-depth look into the responsibilities in the PV agreement
• PV agreements in PSMF

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. She has broad experience in many pharmacovigilance areas (e.g., risk management, PV systems, medical writing) and currently acts as EU/UK QPPV for several clients. Click here for more details.

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

 

Jana is an expert in pharmacovigilance with more than 15 years of working experience from several global pharma companies. She joined PrimeVigilance in 2014 and she currently holds the position of PV Director. She serves as EU QPPV for several clients and conducts PV audits as requested by clients. Click here for more details.

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

Ergomed plc Press Release
Guildford, UK – 26 April 2021: Ergomed plc (LSE: ERGO) (“Ergomed” or the “Company”), a company focused on providing specialised services to the pharmaceutical industry, announces that its PrimeVigilance business, a global leader in the provision of pharmacovigilance and medical information services, has established its new legal entity and regional office in Japan and is fully operational from 26 April 2021.
The new subsidiary company, trading as PrimeVigilance Japan KK, is based in Tokyo and offers a comprehensive range of pharmacovigilance services, including a dedicated Japanese safety database. Full Japanese language Medical Information services are also provided.
This expansion provides existing and prospective international PrimeVigilance clients the opportunity to extend their product coverage into the strategically important Japanese pharmaceutical market, the fourth largest globally after the US, the EU and China. It also provides PrimeVigilance and Ergomed the opportunity to provide high quality specialist services to domestic Japanese companies, opening up a new market.
PrimeVigilance has a strong operational presence in Europe and the recent acquisitions of Ashfield PV and MedSource, as well as significant organic growth in the US, have elevated PrimeVigilance into a market leading position in North America. The new facility in Japan adds Asia to Ergomed’s global footprint, enabling PrimeVigilance to offer operational services in all major regions, with pharmacovigilance and medical information professionals based in each territory, providing both local and global expertise.
Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: “Ergomed has provided a breadth of services and expertise in Asia both as a CRO and as a pharmacovigilance specialist through its outsourcing model for many years. With a solid base of international clients in Japan, Ergomed is establishing its own pharmacovigilance and medical information infrastructure to serve current and future clients and further strengthen our global operational and commercial footprint in the strategically important Asia region. Following the two US acquisitions in 2020 of Ashfield Pharmacovigilance (now PrimeVigilance USA) and MedSource, this marks another major step in our strategy to establish Ergomed as a leading international pharmaceutical services specialist.”
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 / Matthew O’Dowd (Nominated Adviser)
James Black (Broker)
Consilium Strategic Communications	Tel: +44 (0) 20 3709 5700
Chris Gardner / Matthew Neal	ergomed@consilium-comms.com
Olivia Manser / Angela Gray

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

 

In this new webinar, our expert speakers Dr. Marcela Fialova and Dr. Jana Hyankova will give their insight into Covid-19’s impact on the EU and the UK pharmacovigilance processes, highlighting the challenges that the Pharmaceutical Industry has had to face and how they adapted.

Choose between one of 2 sessions available for this webinar:

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

Key learnings include:

• Impacts of the COVID-19 pandemic for global pharma companies
• Updates of EU PV legislation with respect to COVID-19
  • COVID-19 terms to MedDRA
    • Pharmacovigilance activities with respect to COVID-19 vaccines
      • RMP, Periodic Safety Report, Signal Management, etc.

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. She has broad experience in many pharmacovigilance areas (e.g., risk management, PV systems, medical writing) and currently acts as EU/UK QPPV for several clients.
Click here for more details. 

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

Jana is an expert in pharmacovigilance with more than 15 years of working experience from several global pharma companies. She joined PrimeVigilance in 2014 and she currently holds the position of PV Director. She serves as EU QPPV for several clients and conducts PV audits as requested by clients.
Click here for more details. 

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

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 

 

• 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.

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 

 
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.

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