On 19 September 2019, Mithra blew its twentieth candle after 20 years of hard work and unwavering passion with one goal: becoming a global leader in women’s health. Comac Medical was officially invited and was honored to attend the exclusive event, which took place at Mithra CDMO, Belgium.
Comac Medical takes pride in having contributed over the past several years to Mithra’s successful clinical development programs.
On 1st October 2019, the biotech company signed a License and Supply Agreement (LSA) with Mayne Pharma Group Limited, a leading Women’s Health player in oral contraceptives in the United States (US), for an exclusive license to commercialize Estelle® in the US. This is the largest contract in the history of the company.
Building on the success of its long-running US-based counterpart, the SCOPE Summit for Clinical Ops Executives this year took place in Barcelona, Spain, on 17-18 September, 2019. The Conference topics deep dived into the challenges and opportunities for clinical research in Europe and beyond.
Comac Medical’s team took the opportunity to connect with experts and clients, and to keep a finger on the pulse of the industry. The two-day event gathered clinical innovation leaders, clinical ops execs, functional heads, category managers, and those responsible for the planning and management of clinical trials in Europe and the rest of the world.
The SCOPE Summit covered important issues in clinical trial operations including protocol development, global site selection, feasibility, site management, patient engagement, enrollment planning, patient recruitment, patient retention, improving site-study activation and performance, functional/full-service outsourcing and partnerships, new regulations and guidelines, Risk-Based Monitoring (RBM), clinical technology, big data and analytics, Real-World Data (RWD), Artificial Intelligence (AI), resource management, trial forecasting, and improving overall quality and speed of clinical trials. Comac Medical’s team seized the occasion to share best practices and discuss the new era of analytics-driven and patient-centric trials with leaders from pharma, specialty pharma, biotech, vendor companies, and academic research centers.
Comac Medical proudly announces that the Bulgarian Memory Foundation has received the Special Award from the Economic Policy Institute and Sofia Municipality, Program “Europe” for sustainable European perspective for its project: “Youth Employment through Modern Education based on Digital Technology and Entrepreneurship” (BE – educated, employed and entrepreneurial), implemented by the Bulgarian Memory Foundation in 2017 in partnership with “Lozenets”region. Bulgarian Memory Foundation is an integral part of Comac Medical’s corporate social responsibility policy. Believing that our country still has unfulfilled innovative potential, for 12 years now, the Foundation has been investing in young people to believe in themselves and find their way to prosperous future.
The successful project has contributed to the integration of digital technology, innovation and entrepreneurship into the educational process of a more modern education in the capital.
During the event, held at the new BTA Multimedia Center, the Chairman of the Bulgarian Memory Foundation and Comac Medical’s Executive Director Dr. Milen Vrabevski presented the Honorary sign of the Bulgarian Memory Foundation to the Mayor of Sofia Mrs. Yordanka Fandakova for high public service and contribution to the civil society. The sign represents a bronze statuette of Tsar Simeon the Great, who is associated with the “Golden Age” of the Bulgarian culture, spirituality and prosperity. In her address, Mrs. Fandakova thanked for the insignia and for everything that Bulgarian Memory Foundation does for the young people of Sofia and mostly for the preservation of spirituality in the capital.
Comac Medical executive team was part of the 6th edition of the Tech Tour Growth Summit in Geneva & Lausanne.
The event brought together 50+ of Europe’s boldest CEOs – the entrepreneurs with the vision and drive to build game changing businesses.
“Our repeat business rate is above 70 %, because our full-service capabilities resulting in cost and process effectiveness. For over 22 years we are maintaining expertise in various therapeutic fields such as oncology, cardiology, neurology, rheumatology, and endocrinology is our key drive,” said Dr. Milen Vrabevski, CEO of Comac Medical.
At Tech Tour Growth Summit our executive team discussed and presented our high-tech integrated system for collecting, managing and analyzing clinical data. The innovative vision of Comac Medical was recently acknowledged with by the President of Republic of Bulgaria Rumen Radev, who delivered the prestigious mark “Excellence in Innovation”.
The President of the Republic of Bulgaria Rumen Radev delivered the prestigious mark “Excellence in Innovation” to the owner and CEO of Comac Medical Dr. Milen Vrabevski as a finalist in the “Innovative Enterprise of the Year” competition for 2016, 2017 and 2018. The award is given for the first time for high quality and originality of the innovations of the Bulgarian companies, their impact on the national and world market, on the environment and the society, for the efficiency of the business model.
Comac Medical received the prestigious award for the development of a hi-tech, integrated system for collecting, managing and analyzing clinical data. The innovation enables greater accuracy and precision in relevant analyzes and studies within the framework of ongoing clinical trials.
This is not the first prize of such kind for Comac Medical. In 2016, the company was nominated for “Most Innovative Enterprise”. In its detailed IMP³rove Benchmarking report for assessment of the innovative potential of the companies in Europe, the European Commission placed Comac Medical among the so-called Growth Champions, awarding it with its Seal of Excellence. In addition, Comac Medical placed Bulgaria on the map of Horizon 2020 with an innovative approach to early diagnosis of inflammatory and degenerative lung processes such as asthma, COPD, tuberculosis, lung cancer, etc.
The brand “Excellence in Innovation” is given to the finalists in the “Innovative Enterprise of the Year” competition. It is organized by the Applied Research and Communications Foundation and Enterprise Europe Network – Bulgaria and under the patronage of the President of the Republic of Bulgaria Rumen Radev.
Milen Vrabevski, MD, owner and CEO of the biggest clinical research organization in Southeastern Europe was invited as an honorary speaker at the 2nd International Governance Summit in Lyon, France. He was the only representative from Eastern Europe at the international forum which gathered over 30 visionary speakers – diplomats, economists, innovators, entrepreneurs, philosophers and political leaders.
Dr. Vrabevski took part in one of the key debates of the event with the promising topic: “21st century: Towards a more human capitalism? Can we think of more inclusive models that are more cooperative?”. He gave his business perspective to the new generations, in order to promote cultural inclusion across Europe.
“My decision as the owner of the largest CRO in the region to invest back into society is based on my willingness to facilitate its own move and growth and practically to enable successful and capable people to bring that same society to progress”, said Dr. Milen Vrabevski, CEO of Comac Medical, during the debate.
Being an essential part of the prestigious casting of international speakers Dr. Milen Vrabevski shared his experience and good CSR practices as an innovator and entrepreneur who has been successfully growing his business for 22 years in 25 countries across Europe and beyond. Dr. Vrabevski answered to the numerous questions from the students and the French media. Comac Medical’s Executive Team was also present at the event in order to expand their cooperation with French companies.
The ambition of HAPPY GOVDAY is to reflect, imagine and explore a positive, responsible and efficient governance through the perspectives of people like Dr. Milen Vrabevski. Throughout the day, key topics like sustainable and responsible governance, eco-citizenship, more human capitalism, transmission and trust were discussed.
For Virginie Nogueras, creator of the event and CEO of the company Ex’Pairs Training, “the 2nd edition of Happy GovDay has governance as its main theme inclusive with the intention of reconciling business and social issues.”
The authoritative magazine Pharma Tech Outlook made a special interview with Dr. Milen Vrabevski, CEO of Comac Medical whose company is among the Top 10 CROs in Europe for 2018.
“We have full-service capabilities resulting in cost and process effectiveness, which is why our repeat business rate is above 70 percent. Maintaining extensive expertise in various therapeutic fields such as oncology, cardiology, neurology, rheumatology, and endocrinology is our key drive,” says Dr. Milen Vrabevski in the interview.
Read the full material in Pharma Tech Outlook Magazine (p.19) and see what are the key factors and overcame challanges that lead Comac Medical to the success of being the biggest clinical research organization in Southeastern Europe.
We are proud to announce that Pharma Tech Outlook Magazine placed Comac Medical among the “Top 10 CROs in Europe – 2018”. In the selection process Pharma Tech Outlook’s distinguished panel comprising CEOs, CIOs, VCs, industry analysts and the editorial board has evaluated the Comac Medical’s competency to provide efficient as well as cost-effective retail solutions and services.
“The greatest challenge of being a niche service provider is to remain resourceful when in parallel ensuring quality, excellence, and timely milestone delivery. In order to achieve that, we are maintaining expertise in abroad spectrum of Therapeutic Areas for delivering innovative solutions,” commented Dr. Milen Vrabevski, CEO of Comac Medical.
Take a look at the full publication in Pharma Tech Outlook Magazine about Comac Medical’s top ranking in Europe and the special interview with Dr. Milen Vrabevski.
Comac Medical Quality Group has contributed in a global quality initiatives as Research Quality Organization Volunteer Programme. Our team contribution is related to the auditing techniques. RQA Volunteer Programme received Bronze at the recent Association Excellence Awards 2018.
In the judges’ view, the RQA Volunteer Programme is, “A great initiative. The importance of volunteers to many associations cannot be overstated.”
Durham, North Carolina and Sofia, Bulgaria. Health Decisions, Inc., the leading US full-service women’s health specialty CRO and Comac Medical, a full-service CRO/SMO operating in 24 European countries, today announced an expansion of their strategic alliance to conduct women’s health clinical trials in the United States, Western and Central and Eastern Europe.
“Health Decisions is pleased to strengthen its strategic women’s health alliance with our colleagues at Comac Medical,” stated Health Decisions’ Chief Executive Officer Patrick Phillips, BSc (Hons), D.Phil. “The Health Decisions/Comac Medical alliance provides sponsors of women’s health trials with extensive therapeutic and operational expertise and access to hundreds of investigational women’s health sites in the United States and Europe. These regions provide care for hundreds of millions of women and generate approximately two-thirds of the revenues of the global biopharmaceutical industry. This strategic alliance will enable Health Decisions to fulfill its mission of improving healthcare outcomes for women worldwide and assisting sponsors who share that goal.”
“Comac Medical is delighted at the expansion of our strategic alliance with Health Decisions for the conduct of clinical trials in women’s health,” stated Milen Vrabevski, MD, Comac’s founder and Chief Executive Officer. “Our strategic alliance provides US and European biopharma companies with comprehensive clinical development services for women’s health products in Europe and the US. These regions offer advanced regulatory environments and both the funding and the investigational sites for most of the world’s clinical trials.”
Benefits of the Health Decisions-Comac Strategic Alliance for Women’s Health Trials
Drs. Phillips and Vrabevski summarized the benefits of the Health Decisions-Comac Medical strategic alliance as follows:
- Provides unrivalled therapeutic and operational capabilities to better enable our clients to deliver medicines of value in a wide range of areas related to Women’s Health
- Provides global access to Key Opinion Leaders and a site network of outstanding investigational sites in both the US and Europe.
- Will provide women who want to participate in clinical trials with broader access to experimental medicines across key areas of need
- Provides benefits to clients who need to perform global Phase 2 and 3 trials but who are also looking to partner with a specialty full service CRO focused in the Women’s Health arena
- Provides services for phase 1-4 clinical trials in both OB/GYN indications and high-female-prevalence indications like osteoporosis, migraine and immune-mediated disorders
About Health Decisions
Health Decisions is a full-service CRO offering therapeutic, operational and regulatory excellence for clinical development of drugs, diagnostics, medical devices and combination drug/devices in all areas of women’s health. Based on therapeutic and operational experience and investigator relationships developed in studies conducted over the past 28 years, Health Decisions successfully addresses the challenges of developing drugs and devices in areas including reproductive and sexual health, menopause, pain management, osteoporosis/osteoarthritis, reproductive psychiatry, and gynecologic oncology. In addition, Health Decisions conducts studies of diagnostics in women’s health and related areas, including oncology and infectious disease. Health Decisions is headquartered in Durham, NC.
About Comac Medical
Comac Medical is a full-service, boutique CRO/ SMO operating in 24 European countries offering clinical development in early phases in own University-based Clinical Pharmacology Unit, as well as excellence in late phase trials of medications and medical devices. Through a network of Key Opinion Leaders and dedicated healthcare institutions, Comac Medical has been managing and monitoring clinical studies in all therapeutic areas (oncology, cardiology, respiratory, rheumatology, renal and hepatic, vaccines, etc.) throughout Europe for the last 20 years. Comac Medical has strong Biometrics and Bioanalytical capabilities adding value to its full-service expertise. The unique relationship with Academia in research and development of innovative products has resulted in winning a Horizon 2020 grant and a recognition of Comac Medical by the European Commission as an innovative company. Comac Medical is based in Sofia, Bulgaria.
Media Inquiries Media Inquiries
Health Decisions Comac Medical
Leslie Hammill Communications Department
Marketing Manager
+1 919.967.1111 ext. 520 +359 888 0882 07
lhammill @ healthdec.com press@comac-medical.com
