Comac Medical

Continuous Investigator Education, Training and Support

admin — Fri, 18 Jun 2010 07:05:26 +0000

COMAC MEDICAL‘s commitment to improving the clinical research environment includes education, study specific and ethical training to investigators and regulators from the entire Balkan region. We believe that sharing expertise and experience with our investigators’ network contributes to the long term perspective for sustainable development of clinical research enterprise in the region.

Active Academia – Business Cooperation

admin — Fri, 18 Jun 2010 07:04:55 +0000

In recent years, we are continuously developing a framework for cooperation with the major Bulgarian university hospitals in order to encourage medical students’ awareness and interest in clinical research projects. Our strategic goal is building a National Clinical Research and Coordination Center. The successful completion of this project will provide succession and sustainability of the good clinical and ethical practices by continuously educating and providing opportunities for professional development to all medical students with interests in the field of clinical research.

Scholarship opportunities

admin — Fri, 18 Jun 2010 07:03:00 +0000

We have an ongoing tradition to grant scholarships to distinguished students in their last year of education, interested in gaining knowledge and experience in clinical research projects. The scholarship allows students in Medicine and Pharmacy to be trained in the company’s headquarters in Sofia and to work with professionals in all phases of clinical research: from I – IV, BA/BE studies.

Patient brochure distributed to the public for free in 5 European languages

admin — Fri, 18 Jun 2010 07:01:21 +0000

Following our commitment to educate and inform the public and the research professionals we have created a patients brochure – “Inside Clinical Trials”. It provides essential information and insight about clinical research participation; what it means to be an active participant in all phases of the process, patient protections and key questions for patients. The educational brochure contributes to a greater awareness, credibility and understanding of the importance clinical research projects.

COMAC MEDICAL sponsors the First Educational Seminar in Eastern Europe – CDISC Sofia 2009

admin — Mon, 09 Feb 2009 16:13:14 +0000

The Association for Good Clinical Practice and Clinical Research Development, chaired by Milen Vrabevski, MD - is a sponsor and organizer of the first educational workshop in Eastern Europe – CDISC European Educational Roadshow, Sofia/Bulgaria. The seminar was opened by Mrs. Yordanka Fndakova, Deputy Mayor of Sofia – at the Grand Hotel Sofia on Thursday 19th February 2009. The event, organized in association with the Clinical Data Interchange Standards Consortium (CDISC), aims to provide to clinical research specialists and regulatory authorities from the Balkan countries good adoption and compliance with the global standards for acquisition, exchange, submission and archive of clinical research data and metadata. The main objective is to raise delegates’ awareness of the purposes of each standard of how they might positively impact their own research and development operations. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The European Medicines Agency (EMEA) recognizes the leading role of CDISC in Europe and regularly requires CDISC participation in technical advisory committees.

COMAC MEDICAL covers Lithuania, Latvia and Estonia with the opening of fully operational structure in Vilnius

admin — Mon, 12 Jan 2009 16:19:47 +0000

COMAC MEDICAL announces the start of fully operational office in Vilnius, Lithuania since the beginning of 2009. Our new expanded capabilities provide us the opportunity to cover additionaly the clinical research sites and local scientific societies in Lithuania, Latvia and Estonia.If you consider the prospect for conducting clinical trials in the Baltic region we shall be glad to kindly present to your attention the advantages and the potential of our new branch in terms of: highly experienced team, predictable regulatory environment, competitive submission /recruitment timelines and good recruitment.

Our Lithuanian branch meets the internal COMAC MEDICAL standarts and quality requirements proven in more than 100 clinical studies (phases I to IV) and by more than 200 audits/ inspections and co-monitoring visits (including 2 on site FDA inspections with NAI letters outcome). We guarantee consistency of performance and level of expertise under the supervision of our upper managerial staff and internal QC/QA procedures, developed and proved on the territory of 7 East European countries with a population of around 52 mln with common habits and medication therapy: Bulgaria, Romania, Serbia, Macedonia, Bosnia and Herzegovina (incl. Republic of Srpska), Montenegro