Big picture - Why invest in Ergomed PLC
Ergomed PLC Snapshot
With over 20 years of experience, we offer custom made development solutions in every stage of development from proof of concept to late stage programmes.
Founded in 1997, Ergomed plc is dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs. Operating with a global footprint in over 55 countries, Ergomed enables our clients to access solutions even for their toughest clinical development and trial management challenges from early phase to complex late stage programmes. Ergomed has provided and managed clinical development, trial management and pharmacovigilance services for over 100 clients: these ranging from top 10 pharmaceutical and generics organizations to small and mid-sized drug development companies.
Orphan Drug Development
Orphan drug trials are not just smaller versions of large trials and have specific requirements. We focus on the rare disease patient, and how to make a positive impact on their lives.
Our orphan team is led by PSR Orphan Experts (PSR), Ergomed’s rare disease subsidiary. PSR is one of the few companies exclusively focused in orphan disease drug development and recognised as a leading expert in assisting biotech and pharma companies in the rare disease niche. Through our Site Management model and Study Physician Team Support, we find the hard to locate patients around the globe and work with the investigative sites to create the best designs to maximise clinical programs and registries.
Contact PSR - The Orphan Experts
Orphan drug development is Ergomed’s core strength, and we are committed to helping those in need. Our expert team allows our clients to implement patient driven solutions in their clinical trials, and we believe that patients will define our future landscape, including the rise of both precision and preventative medicine.
Following are the key factors that set Ergomed and PSR’s joint expertise apart:
. Unique insight into orphan drug programs to accurately address the specific challenges and project needs that rare disease trials require in order to provide an innovative and solid infrastructure
. Extensive experience in innovative regulatory & clinical development (Pharma, biotech, CRO, Academia)
. Global access to hard-to-find patients in under-served regions
. A regulatory consultancy service to provide complete support for orphan drug related interactions with the EMA and FDA (e.g. Orphan Drug designations, PIP, Protocol Assistance/Scientific Advice)
. A unique site management model that allows for faster recruitment of quality patients and site coordination
. Expertise in Natural History Studies to better understand the etiology and progression of the disease, which allows for the setting up of crucial endpoints in the development process.
. Complete staffing solutions specialising in placing team members with orphan drug experience
. Unique access to patients in the Middle East and North African regions, which has the highest prevalence of genetic disorders in the world
Study experience is at the heart of what makes a CRO successful.
As a full-service CRO, we offer complete solutions in all therapeutic areas, but we specialize in:
. Orphan Drug Development
. Oncology / Haematology
. Allergy / Respiratory
. Neurology / CNS
Clinical Expertise: Phase I–IV
Complete solutions for all phases of drug development.
Through our 20 years of successful history, Ergomed has acquired significant experience in both pre-approval and post-approval trials. Our proven service offering ensures that we can provide custom solutions to assist in recruiting patients enrolled on-time and on budget. For Late Phase studies we have a dedicated team to support Real-World Evidence and Observational studies.
As a full-service provider, we offer a complete solution for trials of nearly any size, location, type or phase. Our experienced team has years of knowledge in the unique aspects of the most difficult of projects. We are proud that our full-time staff, of which approximately 25% has a doctorate degree, can provide unique insight into your ongoing and upcoming projects.
We proudly differentiate our Pre-Approval services through:
. A unique site management model designed to maximise site effectiveness and timelines
. Study Physician Support to increase communications and improve compliance
. Extensive development expertise through our dedicated medical teams and expert network
. A full-service offering to ensure a unified approach to your trial
Site Support Services
Our unique approach to Site Management ensures effective patient recruitment reducing time and cost of clinical trials.
Being a full-service provider, Ergomed is able to offer a complete solution for your studies unique needs. Our Project Management and CRA teams form the core of the organization, many of whom are MDs, PhDs or have other medical-related backgrounds and they assist in leading the organization to ensure success on all of the projects that we are involved in.
Ergomed uses a unique approach to ensure that we maximse the management of the site relationship. Our approach as established over 20 years ago by our company’s founder, Dr Miroslav Reljanovic, who was previously a Principal Investigator. Ergomed’s assessment and knowledge of the experience of physicians and nurses, investigator facilities, pharmacy and laboratory services significantly improves the access to and the availability of appropriate patients. Our Site Management model is an integrated part of our approach to the management of clinical trials.
Through a network of Site Coordinators serving sites across the globe, this enables us to offer higher ‘patient-per-site’ ratios in comparison to other CROs. Our team provides continuous and ongoing site support that allows us to achieve enhanced patient recruitment rates whilst maintaining high quality data. Early and meticulous site evaluation in the feasibility process is critical in ensuring accelerated recruitment.
Our unique Site Management Support Solution allows us to offer:
. Faster recruitment
. More patients per site
. Enhanced data quality
. More timely data entry
. Fewer data queries
. Better compliance to GCP
Board of Directors
Peter George joined Ergomed as a non-executive director in May 2014 and has over 20 years’ experience in the pharmaceutical services industry. Peter stepped down as Chief Executive Ofﬁcer of Clinigen Group plc (AIM: CLIN) at the end of 2016. He started Clinigen in 2010 as a global specialty pharmaceuticals and pharmaceutical services business and by 2016 it had a c.£1bn market cap, being one of the most successful recent floats on AIM.
Prior to Clinigen, he was CEO at Penn Pharma, having led a £67m management buy-out in 2007. Before this, Peter was executive Vice President for Wolters Kluwer Health with responsibility for Europe and Asia Paciﬁc regions.
Peter has also held roles as the Chief Operating Ofﬁcer of Unilabs Clinical Trials International Limited, and Head of Clinical Pathology NHS.
Peter is also Chairman of Wichtig International, Mitre Group Limited, XPG Ltd, Marco Polo Events Limited, and Benchmark Holdings PLC, companies he owns or has significant holdings in.
Peter is the Chair of Ergomed’s Nomination Committee and is a member of the Audit and Risk, AIM Compliance and Remuneration Committees.
Dr Miroslav Reljanović
Founder and Executive Vice-Chairman
Dr Miroslav Reljanović is a medical doctor and a board-certified neurologist. Whilst practicing as a physician in a large WHO Collaborating Centre in Zagreb, he was the clinical investigator in numerous Phase II and III studies in the field of neurology and a consultant to various pharmaceutical companies. In 1997 Miro founded Ergomed and he introduced the novel Study Site Coordination model as an intrinsic part of the conduct of clinical studies. This model became a landmark of the Ergomed approach to clinical research, which is paramount to provide high quality.
Miro successfully introduced the first European innovative co-development business model and he has completed several partnerships with European and North American listed biopharmaceutical companies. Together with co-founder Elliot Brown, MB, MRCGP, FFPM, a well-known international expert in drug safety, Miro started PrimeVigilance in 2008, which soon became a leading specialist vendor of contracted pharmacovigilance services to the pharmaceutical industry.
Miro led Ergomed through a successful IPO on the AIM market of the London Stock Exchange in July 2014 and the subsequent completion of five acquisitions and a secondary offering.
Miro transitioned to Executive Vice-Chairman in July 2017 in order to support the Board in growing and developing Ergomed’s CRO offering and to provide strategic guidance on Ergomed’s co-development business and wholly-owned pipeline.
Miro is a member of Ergomed’s Nomination Committee.
Chief Executive Officer
Stephen Stamp joined Ergomed in January 2016 as Chief Financial Officer and in December 2017 he was appointed Chief Executive Officer. Stephen brings to Ergomed more than 30 years of experience in corporate finance and general management in both public and private companies in the UK and the USA. Stephen joined Ergomed from US-based AssureRx Health, Inc, a personalised medicine and bio-informatics company, where he was CFO. Prior to this he was CFO of EZCORP, Inc. (NASDAQ:EZPW), a consumer financial services company and Chief Operating Officer and CFO at Xanodyne Pharmaceuticals, Inc, a specialty pharmaceutical company.
Before leaving for the US, Stephen was Group Finance Director at Shire Pharmaceuticals (LSE:SHP, NASDAQ:SHPG) where he led the IPO on the London Stock Exchange as well as a number of major acquisitions and financings. During his time at the Company, Shire’s market capitalisation increased from GBP20 million to GBP3.1 billion. He was also Group Finance Director at Regus Plc (LSE:RGU) where he successfully listed the Company on London Stock Exchange Main Market and NASDAQ. Earlier in his career, Stephen was an investment banker with Lazard in London, advising mainly public companies on cross-border M&A and corporate finance. Prior to Lazard, he worked for KPMG in London where he qualified as a Chartered Accountant.
Stephen is a member of Ergomed’s Remuneration Committee.
Chief Financial Officer
Bringing over 20 years’ experience at the Chief Financial Officer level, Stuart has managed companies on the London, NASDAQ and Oslo Stock Exchanges. He has significant international experience in early stage and growth companies as well as managing significant and complex change projects. Stuart’s experience has been gained primarily in the energy and technology/telecommunications sectors where consistent project service delivery across a number of geographies has been a key feature of business success.
To expand on some of Stuart’s achievements; he was CFO at Acergy SA responsible for the financial restructuring of the business and implementation of the new business strategy which took Acergy from $0.1bn to $6.0bn market capitalisation over a four year period. Recently he was CFO at CEONA, where he was responsible for the early stage set-up and growth of the business. He was also CFO at Bibby Offshore Holdings Limited where he also managed the strategic development and M&A activities and oversaw its recent recapitalisation.
Dr Jan Petracek
Chief Operating Officer
Dr Jan Petracek is an internationally recognised entrepreneur and expert in pharmacovigilance, leading critical developments in the field and implementing the latest technology and science. He has proven his entrepreneurship skills by establishing multiple successful organisations in non-profit (medical student union – TRIMED), government (new pharmacovigilance and risk management departments of national (SUKL) and European (EMA) regulators), as well as private profitable businesses (PharmInvent).
Jan is a medical doctor (Charles University in Prague) and holds an MSc with distinction (Imperial College London) in Quality and Safety in Healthcare. He is on the Board of the International Society of Pharmacovigilance, leading development of the Global Standard for Career Framework in Pharmacovigilance. He is a popular international speaker at pharmacovigilance conferences and training seminars.
While being the Head of Risk Management at the European Medicines Agency (until 2010), Jan was leading development of the guidelines for risk management of Advanced Therapies, ICH guidelines, and contributed to the foundation of EU Good Pharmacovigilance Practice. In his consulting career (since 2010), he has worked as an EU QPPV, auditor, system architect, and strategic advisor for global, mostly US based companies.
Jan joined Ergomed in November 2016 and serves as CEO of PrimeVigilance and PharmInvent. In December 2017 he was appointed Chief Operating Officer of Ergomed Plc.
Christopher was the CEO and a founding partner of Code Securities, a healthcare focused advisory and broking ﬁrm, which was formed in 2003, acquired by Nomura in 2005 and continued as Nomura Code Securities until late 2013.
Chris was previously head of the Life Sciences Group at WestLBPanmure, having founded that ﬁrm’s activities in the sector in 1993. He has advised companies at all stages of development on transactions including private ﬁnancings, IPOs, secondary offerings and mergers and acquisitions.
Prior to WestLBPanmure, Chris was Managing Director of Corporate Finance at Panmure Gordon, after eight years as a Director of Corporate Finance at Hoare Govett and nine years in Corporate Finance at Charterhouse Japhet. He has an MBA and read biology at Sussex University.
Chris is the Chair of Ergomed’s Audit and Risk, AIM Compliance and Remuneration Committees and is a member of the Nomination Committee.
General Counsel and Company Secretary
Sanja Juric joined Ergomed in 2016 after more than 30 years’ career in international law and after having assisted Ergomed as its outside advisor for more than 15 years. As Ergomed’s counsel, Sanja has been on Ergomed core co-development team since the first deal and helped close several co-development transactions.
Sanja holds degrees from the University of Zagreb (LLB, 1985) and the University of Fordham, School of Law, New York City (LLM in International Trade and Business Law, 1992). She has been admitted to the Bar of the State of New York since May 1993 and is listed as an arbitrator with the Chamber of Commerce in Croatia.
Sanja’s experience encompasses both in-house positions, including that of the head of legal affairs of the largest Croatian private company, during the period of its intense expansion via acquisitions and law firm positions. Prior to joining Ergomed, Sanja provided consulting to international businesses and organizations (including IFC, DEG, Avon, Kleeman, Herbalife) and cooperated with multinational law firms (Baker & McKenzie) focusing on cross-border transactions, primarily M&A. Sanja wrote extensively for several international M&A handbooks and participated for many years as an author in the World Bank series of “Doing Business”.
Executive Management Team
Dr Gordana Tonković
Head of Clinical Development
Dr Gordana Tonkovic has been with Ergomed since 2000, and she is Ergomed’s Head of Clinical Development. In this position Gordana provides leadership and vision for the entire organization and she plays a critical role in providing medical, scientific input to our clients. Gordana is a graduate of the University of Zagreb, where she obtained her Doctor of Medicine specialised in Neurology.
Head of Clinical Operations
Sladana Sturlic currently serves as Ergomed’s Head of Clinical Operations. Sladana is one of Ergomed’s earliest employees and has been with the organization since September 1999 and has nearly 20 years of experience in clinical research, focusing on neurology, oncology, haematology, endocrinology, rheumatoid arthritis psychiatry and immunotherapy. She has worked in multiple roles within the organization each of which were within the clinical operations department. Prior to starting at Ergomed, Sladana was a Nurse for over seven years at the Clinical Hospital Center Zagreb and she has a BSc Degree in Entrepreneurship Economics from Vern’ University of Applied Sciences.
Dr Roger Legtenberg
Chief Executive Officer - PSR
Dr Roger Legtenberg is the Chief Executive Officer of PSR Orphan Experts and PSR Pharma Resource, which is Ergomed’s orphan drug subsidiary. Roger has nearly twenty years of CRO experience with the last eight years CEO establishing significant progress and growth focusing on the ‘why’ in Rare Diseases. Roger is a frequent speaker and event organizer on rare disease focused events and he is also a member of the board for ACRON, the Advice Center Orphan Drugs and Rare Diseases and also served as member of the board for Biofarmind. Roger has a PhD in Medical Sciences from University Medical Center Nijmegen.
Dr Hans-Peter Hucke
Global Head of Data Management and Biostatistics
Hans-Peter Hucke holds a PhD in Statistics from the University of North Carolina at Chapel Hill. Since 1989 he has served as a statistician in different leading positions in clinical research and contributed to more than 150 clinical studies in various phases and indications. He joined Ergomed in 2016 and currently serves as Global Head of Data Management and Biostatistics.
Dr Alex Artyomenko
Head of RWE and Late Phase Division
Dr. Alex Artyomenko currently serves as the Head of Real-World Evidence and Late Phase department for Ergomed, and has been in this position since February 2017. Initially trained as a cardiologist, Alex managed acute care for ICU patients prior to joining the research field. Alex has over 15 years of clinical research experience, and has been involved in developing and implementing study designs and operational strategies for global studies and programs, involving many types of observational studies and therapeutic indications. He is an active member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), focusing on improving standards for observational research, and helping the companies to strengthen the value of their products through Real-World Evidence.
Dr Thomas Portele
Head of Global Project Management and Monitoring
Dr Thomas Portele is the Head of Global Project Management and Monitoring, a position that he has held since January 2017 and is the Head of our Frankfurt office. Thomas has over 20 years of experience in the clinical research space, including pre-clinical development through Phase IV trials with special emphasis on phase II and III trials. Thomas has experience in various indications, but has focused on Neurology and Oncology, while acting as a Global Project Director/Manager in Europe, South America, North America, Africa and Asia Pacific/Australia. Thomas obtained his PhD in Cell Biology from Humboldt University Berlin (Germany), a diploma in Oncology from Max Delbruck Center for Molecular Medicine (MDC) and a Master’s degree in Biochemistry from Humbolt-Universitat zu Berlin.
Dr Iwona Kmicikiewicz
Head of Pharmacovigilance Department / Office Director
Dr. Iwona Kmicikiewicz, of Kraków Poland obtained her PhD in Biology from Jagiellonian University (Kraków), with specialization in endocrinology. She served in the capacity of a Pharmacovigilance Department Safety Officer and as a local QPPV in a pharmaceutical company with portfolio of over 100 different products registered in over 40 markets for over nine years. She was engaged in the set-up and maintenance of the safety system with SOP development, preparation, training of staff, processing and reporting activities. Since 2000 she has worked as Project Manager mainly responsible for bioequivalence studies.
Since 2004, Dr. Kmicikiewicz has worked in the capacity of Safety Manager and Project Manager in Ergomed. With 18 years of clinical trial experience she has participated in or led a wide variety of phase II – III multi-centre / multi-national clinical research programmes and large scale trials. Starting in 2008, Dr. Kmicikiewicz was key in the set-up of Primevigilance providing for both clinical and post-registration safety services. Since 2011, she has taken the role of Manager of Clinical Operations in Ergomed Krakow office, with responsibility for leading clinical operations in Poland and the related countries. Beginning in 2013, she has served in the capacity of a Head of the Clinical Safety Department, Project Director and Office Director in Ergomed Polish office.
Dr Shazia Rahman
Head of HR and Resourcing
Dr Shazia Rahman is Ergomed’s Head of HR and Resourcing and she has been with the organization since September 2016. With over 20 years of clinical research experience in clinical operations and resource management, Shazia’s background and insight allows for Ergomed to attract the most qualified team members the industry has to offer. Shazia obtained her Doctorate of Philosophy, Medicinal Chemistry from the University of Sussex, UK.
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ERGOMED Istrazivanja Zagreb d.o.o.
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Phone: +49 69 3487288-0
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ERGOMED sp. z o.o.
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ERGOMED PLC I 20.
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1601 Trapelo Rd
Waltham, MA 02451 USA
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PSR – The Orphan Experts
Crown Business Center Schiphol
Planetenweg 5, 2132
Ergomed Center for Data Management and Statistics GmbH (CDS)
Im Mediapark 2
Herriotstraße 1, 60528
Phone: +49 69 3487288-0
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