Outsourcing in Clinical Trials: Medical Devices (EU)
Munich, February 6-7, 2019
Optimapharm’s CBDO, Maxime Stevens, will be attending the The 6th Annual Outsourcing in Clinical Trials Medical Devices Europe Conference 2019, in Munich. This conference will bring together clinical trial sponsors from across Europe, providing engaging presentations. Join Max in exploring the latest regulatory challenges for medical device manufacturers and the opportunities for greater efficiency in trials.Contact Us
6TH CLINICAL OPERATIONS & 7TH ONCOLOGY STRATEGY MEETINGS
NOV 6 & 12, 2018, Boston
OptimaPharm is proud to be sponsoring both the 6 th Clin Ops and 7 th Oncology B2B Strategy Conferences in Boston. Our experts will be attending both conferences, and we invite you to join us for f2f meetings to discuss the latest strategic trends in clinical research, and learn more about our expert delivery of clinical trials in today’s challenging environs.Contact Us
14TH ALIMS SYMPOSIUM
OCT 5-6, 2018, Serbia
Optimapharm is attending the 14th traditional international symposium ALIMS, in Kragujevac.
Meet with our Serbian team to discuss how to transform vision into practice in the regulation of medicines and medical devices.
CLINICAL TRIALS QUALITY & COMPLIANCE CONFERENCE
VIENNA SEP 13-14, 2018
Optimapharm is attending the 3rd annual Clinical Trials Quality & Compliance Conference in Vienna,
Meet us to exchange ideas on achieving inspection readiness and compliance in clinical quality and to discuss our services and support in running clinical trials.
With the new acquisition Optimapharm expands its presence into core European markets by strengthening service offerings to biotech and medical device companies
Optimapharm, a leading independent clinical research organization (CRO) in Europe, acquired Denothex Ltd., significantly strengthening its presence in key European markets particularly in France, Germany, Switzerland, Spain and Italy and thus broadening its customer base.
Denothex is a boutique CRO headquartered in Switzerland, managing clinical trials of all phases across Europe and Israel, with particular focus on biotechnology and medical devices in oncology.
By consolidating Denothex, Optimapharm is becoming one of the leading mid-size CRO companies in Europe. Optimapharm was established in Zagreb, Croatia, and operates through offices in 14 European countries. It covers markets with a total population of over 500 million people and has the expertise to conduct phase I – IV clinical research across Europe with a very strong footprint in Central and Eastern Europe.
“The clinical research market is experiencing a continued rise, and our goals grow with it. With the combination of continuous organic growth and targeted investments into complementary organizations, we have very successfully established ourselves as one of the leading players in the field of clinical research in Europe. We have a proven track record and continue to identify market opportunities and realize acquisitions with a successful integration in order to create more value for our clients, employees and shareholders. “We are enthusiastic about the acquisition of Denothex, which further strengthens our oncology and medical device expertise” said Gordana Gregurić Čičak, CEO of Optimapharm.
In late 2017 Optimapharm successfully acquired and consolidated the Czech company MKS Research, and in November of 2018 attracted a EUR 10 million investment by the Accession Mezzanine Capital fund.
“We have become part of an ambitious fast-growing company with well-structured study operations support and services. The integration with Optimapharm provides our customers with broader access to clinical study centers and patients. We very much look forward to becoming part of such a prosperous organization“, said Dr. Marc Salzberg, Chairman of Denothex.
Since it was founded, Optimapharm has conducted more than 280 clinical studies in 20 countries across Europe and Israel. Demand for CRO services continues to grow steadily, and substantially exceeds the growth rates of the economy globally. According to the 2017 New Market Research Report, the value of the global market for conducting clinical research by 2021 will reach nearly USD 50 billion. The largest market is the US, which accounts for 40 percent, whilst Europe remains the second largest market.
We are proud to announce that OPTIMAPHARM has been recognized in Pharma Tech Outlook
special edition on CRO Europe 2018, wherein we are named one of the Top 10 CRO’s in Europe.
As the CRO industry continues to experience change and adaption, it is without a doubt that clinical trials are becoming increasingly complex and costly. Several emerging trends indicate that there are numerous factors that will continue to define and redefine the role of CRO’s. Pharma Tech Outlook’s distinguished panel has selected the Top 10 CRO’s in Europe 2018, evaluating and recognizing competency to provide efficient plus cost-effective solutions and services to the industry.
Both the Founders of OPTIMAPHARM and their Chief BD Officer discuss OPTIMAPHARM’s in-depth understanding of the regions where they operate, and recognize that the strength of the company stems from its career pathway and culture of teamwork that focuses on high performance.
To read the full article follow this link: https://cro- europe.pharmatechoutlook.com/vendor/optimapharm-customerfocused-approach-to-drug- development-cid-229-mid-30.html
Optimapharm are proud to announce the promotion of Ms Maxime Stevens to the position
of Chief Business Development Officer. Max joined Optimapharm in June 2018, and during
these five months has proven her successful commitment to developing new markets and
clients, and has been a key driver in developing our sales and marketing strategies to a
In her new role, Max will have overall responsibility for delivery of Optimapharm Business Development, and will oversee the sales, communication and marketing strategies of the company. Max brings to the role over 25 years of leadership experience and expertise in global commercial organisations, impacting growth and expansion of new geographic and channel opportunities for significant industry leaders.
We are delighted to announce this promotion which further strengthens our Executive Leadership Team; together bringing decades of experience in the commercial, clinical research and financial sectors, as well as a deep understanding of Optimapharm's business, supporting the next stage of our ambitious growth plans.
Please join us in congratulating Maxime on her new position.
We are pleased to announce that OPTIMAPHARM has become the Associate Member of the
European CRO Federation (EUCROF).
EUCROF (the European CRO Federation), is a non-profit organization founded in 2005 with the objective to promote Clinical Research by improving the knowledge, competence/expertise and skills of Contract/Clinical Research Organizations (CROs) in Europe.
The Federation represents and supports the interests of CROs in Europe towards regulatory bodies, the pharmaceutical, biotech, medical device and other healthcare-related industry within the field of clinical research, as well as the medical and affiliated research community. EUCROF organizes and supports training and education programs to increase the quality of clinical research and to improve collaboration and interaction amongst all stakeholders in the field of Clinical Research in Europe. Active participation in international congresses and meetings further underlines the significant role of CROs in Clinical Research in Europe.
Regulatory Authorities recognize EUCROF as the representative for European-based CROs, regularly calling upon EUCROF to contribute to the never-ending debate on the improvement of rules and regulations.
This is an excellent opportunity for OPTIMAPHARM to actively participate in various EUCROF working groups, share and contribute to the know-how on management of clinical trials, further develop clinical trials expertise, and extend the professional network amongst fellow clinical research experts.
OPTIMAPHARM’s CEO, Gordana Gregurić Čičak, and Sr. Vice President Business Development, Maxime Stevens, will present OPTIMAPHARM at the EUCROF General Assembly in London on 06 and 07 December 2018.
For more details follow: https://www.eucrof.eu/
Mezzanine Management-advised fund AMC IV has committed €10m to support the
growth of OPTIMAPHARM, a leading European full-service clinical research
organization (CRO). The funds are earmarked for organic as well as acquisitive growth
and give the fund a minority stake in the business. The deal marks Mezzanine
Management’s first in Croatia.
OPTIMAPHARM organises, monitors and controls clinical trials of new drugs for clients in the pharmaceutical, biotech and medical device sectors. Founded in 2006 by Gordana Gregurić Čičak and Igor Čičak, the business has developed a market leading position in the Adriatic region and has gone on to conduct over 250 trials across 20 countries in Europe and Israel. It has done this through its 13 offices including in Cambridge, UK and Antwerp, Belgium. This extensive European coverage is complemented by its network of preferred partners in the US and Israel.
Global pharmaceutical companies are drawn to OPTIMAPHARM’s ability to offer high quality professional services at Western European standards but at a more competitive cost. OPTIMAPHARM also demonstrates fast start-up timelines, attractive patient recruitment rates and high-quality data capture. OPTIMAPHARM’s client-focused approach has seen it enjoy strong client recruitment and retention and achieve a repeat business rate of 95%.
With the backing of Mezzanine Management, OPTIMAPHARM is looking to grow through acquiring complementary CROs in CEE to consolidate the regional market and also to expand its presence in Western Europe. One acquisition in the Czech Republic has already taken place and has been fully integrated, with a number of additional opportunities in the pipeline.
The company employs over 120 people, 60% of which have more than eight years’ relevant clinical research experience and 30% of which have medical degrees or a PhD. The management team was recently strengthened with the appointment of a Senior VP of Business Development, who brings with her 25 years’ experience in executive leadership, including seven years with the World Health Organization.
Chris Buckle, Managing Partner at Mezzanine Management, has joined OPTIMAPHARM’s Supervisory Board as part of the deal. He said: “OPTIMAPHARM is a perfect fit for AMC’s tried and tested growth capital investment strategy. Run by an ambitious team of highly accomplished professionals, the business has grown rapidly to become the market leader in its core Adriatic region with an increasing footprint across the wider CEE and Western European regions. We have been in discussions with management for some time and already devised an exciting pipeline of accretive add- on opportunities, which we look forward to supporting, to help transform OPTIMAPHARM into a major independent European player.”
The OPTIMAPHARM deal is the fourth to be funded from AMC IV, with ATM, Netrisk and Nettle already in the portfolio.
Mezzanine Management was advised by KPMG Croatia (financial and tax due diligence) and Wolf Theiss (Vienna and Zagreb, legal, documentation). OPTIMAPHARM was advised by M&A advisors Provectus Capital (M&A) and Buterin & Posavec (Zagreb, legal).
Mezzanine Management is the exclusive advisor to the Accession Mezzanine Capital group of funds, whose total investments exceed €600m. Mezzanine Management has been operating in Central and Eastern Europe since 2001 through its offices in Vienna, Warsaw, Bucharest, Budapest and Prague. The funds’ investment portfolio is diverse with 50 transactions over 12 countries in CEE. The funds are backed by reputable institutional investors, including the European Bank for Reconstruction and Development, the European Investment Fund and a number of banks, funds of funds, pension funds and insurance companies.
Maxime Stevens has an excess of 25 years’ experience in executive leadership and has impacted long-term
growth, operational excellence, and the expansion of new geographic and channel opportunities for
significant companies in industry. Her extensive international experience has been gained particularly in
EMEA, Israel, South Africa, Europe and the US.
Maxime ran Operations Southern Africa for W.H.O (World Health Organization) for seven years, developing medical programs, charities and NGO’s across several countries. She then returned to the UK, moving across into clinical research and accelerating from International Head of Business Development through to CEO of a global CRO within five years. In addition to building, restructuring and growing sales and operational teams, she has been instrumental in managing M&A’s, and led the disaster management of a failing global company with 24 offices and 800 staff, which then became SIX listed 18 months later under her management.
Maxime has dual nationality with South Africa and the UK. She received the W.H.O award for Outstanding Contribution to Ethics in Business and Humanity and was an Honored Member of International WHO’s WHO of Professionals in both 2013 and 2014.
With this appointment, Optimapharm is further strengthening its Business Development team with a strong focus on expertise and capability to offer good-quality and time-focused tailor-made solutions to the most diverse demands of clinical research for both pharma and biotech companies.
Chris is a seasoned financial professional with over 20 years’ experience in providing structured finance and equity capital to companies in both Western and Central & Eastern Europe. Chris is British and lives in Prague. He holds a Bachelor of Science degree from Loughborough University and a Diploma in Marketing.
Since 2005 Chris has been a partner at Mezzanine Management, the first dedicated mezzanine fund manager for Central and Eastern Europe. It manages four funds with total funds raised of over EUR 650 million. The latest fund, AMC Capital Capital IV ScSP was established in mid-2017. The four funds have made 49 investments in 12 countries of the central and eastern European region to date.
BBetween 2000 and 2005 Chris was head of Acquisition Finance, Central and Eastern Europe at Erste Bank where he was a pioneer in the region’s fledgling acquisition finance market.
Before joining Erste Bank in 1997, he was an Investment Manager at HSBC Ventures, a private equity operation focusing on small buy-outs in the UK.
We are extremely pleased to have Chris joining our Board.
For further information please contact:
Human Resources Manager
Phone: +385 1 5553 600
Optimapharm is a leading regional clinical research organization (CRO) in the SEE markets. Over the next three years,
Optimapharm plans to double its revenues via organic growth and add on acquisitions to become the largest
independent CRO in the whole of CEE
Following the global trend of consolidating market positions of clinical research organizations (CROs), Optimapharm, the leading CRO in SEE, acquired the Czech CRO company MKS Research.
By acquiring MKS Research, Optimapharm will enter the Czech market, and further strengthen its portfolio of clients in the pharmaceutical and biotech industries and its market position in Central Europe. The move is in line with Optimapharm’s medium-term strategic objective of becoming the largest independent CRO in CEE, with business operations across Europe and the U.S.
“The clinical research market is experiencing a continued rise, and we have the knowhow, references and strong financial position enabling us to lead the consolidation in the region. Moreover, our ambition is to double our revenues over the next three years, and continue acquiring good-quality companies such as MKS Research,” Optimapharm CEO Gordana Gregurić Čičak said.
By consolidating MKS Research, Optimapharm will have a total of 120 full-time employees and annual revenues over EUR 12 million. Optimapharm is headquartered in Zagreb, Croatia, and has offices in more than ten European countries. It covers markets with over 200 million people and has the expertise to conduct phase I – IV clinical research across Europe and through partners in the U.S.
“We are becoming a part of a much larger company with structured operational support. This means that we will be even better able to focus on projects and growth in the Czech and Slovak markets, while our employees will get new opportunities to develop their careers within an international group and work on more complex projects,” MKS Research executive director Veronika Sebkova stated.
The value of the global clinical research market has been growing in the last several years at annual rates of more than 10 percent. In 2016, it reached USD 31.4 billion. It is expected to reach USD 49.26 billion in the 2017 – 2021 period (New Market Research Report, December 2017). The biggest market is the U.S., accounting for 40 percent of the global market, with Europe being the second biggest one.
Optimapharm is the biggest independent clinical research organization in Southeast Europe. It was founded in 2005 in Zagreb, and has since built up a professional multidisciplinary team with expertise in clinical research in the pharmaceutical, biotech and medical device industries. More than 60 percent of employees have more than six years of experience in relevant clinical research, while more than a third of all employees are doctors in various fields of medicine and life sciences.
Optimapharm has taken part in many international clinical programs that resulted in commercialization of new drugs in the segments of oncology, cardiovascular diseases, metabolic diseases, pulmonology, psychiatry and neurology. Optimapharm has a strong track record in conducting pediatric clinical trials in various indications. The company has the most expertise in clinical research in the field of oncology, cardiovascular and metabolic diseases.
For more information, visit www.optimapharm.eu.
Recognizing needs for further expansion to meet the specific requirements of our customers,
OPTIMAPHARM, the largest Central and South-Eastern European Clinical Research Organisation,
established legal entity and office - in Tbilisi, Georgia and Sofia, Bulgaria.
A significant effort has been made to improve Georgia’s healthcare policy and system in recent years, offering a great potential for running clinical trials in this region and at the same time creating a huge opportunity for the patients to have access to the latest treatments. Therefore, OPTIMAPHARM decided to be a part of these positive developments and to facilitate trial acquisition and execution upon the request of clients. Bulgaria’s presence reinforces OPTIMAPHARM’s intention to increase the capacity of Clinical Operations and to strengthen the presence in Central and South-Eastern Europe.
Having operations across 10 leading countries in the region and offering a full range of clinical trial services from fast patient recruitment, clinical trial design, management and monitoring, to regulatory affairs and data management and analysis, OPTIMAPHARM is recognized as an excellent partner for conducting trials within Emerging regions in Europe.
'We want to support our clients with their plans to conduct cost-efficient and fast enrolling trials and we pay close attention to a more personalized approach to trial execution. By opening new sites with additional resources, we believe this will significantly help in our efforts to provide fast and high quality services for our clients', says Gordana Greguric Cicak, CEO at OPTIMAPHARM.
Business Development Officer
OPTIMAPHARM continues to expand the Clinical Operations team by appointing Ivaylo Yordanov as Country Manager in Bulgaria.
Ivaylo is a skilled Clinical Research professional with over 10 years of experience in one of the top global pharmaceutical companies. Working as a Clinical Research Associate, specializing in Diabetes, Hemophilia, Obesity and Non-alcoholic steatohepatitis, Ivaylo demonstrated exceptional leadership skills and motivation thus advancing initially to Local and later becoming the Regional Trial Manager and finally to the position of Clinical Research Manager at Novo Nordisk, Bulgaria. Ivaylo will supervise and coordinate the complex and challenging activities related to the clinical trial execution where the combination of both clinical research expertise and effective management skills are needed.
A strong and experienced team is key to reaching our ambitions and fulfilling high expectations from our clients. Ivaylo brings a strong know-how in managing clinical research projects making him a great addition to our team as we accelerate the growth of OPTIMAPHARM.
For further information please contact:
Human Resources Manager
Phone:+385 1 5553 600
As a part of the growing strategy, OPTIMAPHARM announced the expansion of its senior
management team through appointment of Goran Vesov, MD as Director of the Quality
assurance and training department.
Goran brings over 17 years of experience in research and pharmaceutical industry. He has a medical background and is a specialist in Paediatrics. His career in drug development started in Novo Nordisk, where he moved from CRA to various leadership positions - such as Clinical Quality and Training Manager, Clinical Research Manager and Head of Clinical Europe East. In 2013 he started working in the Novo Nordisk European HQ in Zurich as a Senior Quality and Education Manager, the position he held until he joined Optimapharm. During his career, Goran has provided quality control/support and training around the globe, acquiring thorough insight in these processes. To develop his leadership skills, Goran has graduated at the prestigious Scandinavian International Management Institute in Copenhagen.
With his experience and knowledge, he is the right person to accelerate the development of Optimapharm by strongly contributing to the advancement of our quality and training systems.
For further information please contact:
Human Resources Manager
Optimapharm, the largest Central and South-Eastern European Clinical Research provider,
continues to offer broad and high quality services to accelerate ambitious clinical
development programs for their Clients. As a result of growing demand for emerging
markets, an office has been opened in Ljubljana, Slovenia in June 2017 and a new, larger
office has been acquired in Skopje, Macedonia in May 2017.
With the increasing capacity of Clinical Operations and strengthening of presence in Central and South-Eastern Europe, Optimapharm has gained considerable strategic value to support the Clients’ growing demand. Optimapharm currently employs over 100 experienced clinical trial professionals covering 12 countries throughout Europe . Optimapharm offers wide range of services across all functional areas including Clinical Operations, Regulatory & Ethics, Clinical Project Management, Quality Assurance, Data Management, Bio-Statistics, Medical Writing and Pharmacovigilance for clinical trials Phases I-IV and non-interventional studies.
Commenting on the investment, Gordana Greguric Cicak, CEO at Optimapharm said: ‘This is a valuable strategic investment for Optimapharm as there is a high demand for conducting clinical research in our region because pharma and biotech companies continue to recognise value of emerging regions.’
Josipa Bello, PhD
Business Development Officer
Mobile: +32 473 51 83 70
Apart from being key regional partner in cutting edge medical research we do not forget to engage as a responsible corporate citizen of the global community. This year again we will be supporting Motovun Film Festival. As primarily dedicated to the films from small cinematographers and independent productions, films that have a hard time fighting their way to theaters and wide audiences, this festival celebrates the authors sticking to their artistic stubbornness, unconventionality and originality. It will take place in small and beautiful medieval town Motovun in Istria, end of July