Comac Medical Ltd. is a Full Service CRO providing a broad network of clinical research sites across South East Europe. Maintaining offices in Sofia, Bucharest, Beograd and Skopje, we have developed successful partnership with the most eminent leaders of the local scientific societies.

Our specific regional knowledge and extensive experience with the best clinical institutions in Bulgaria, Romania, Serbia, Montenegro, Bosnia and Herzegovina, Macedonia and Republic of Srpska offers a strong synergy in clinical research enterprise.

The key drivers of our investments in clinical research and development are our creativity, our incessant striving for learning and challenge, as well as the excellent performance of our associates at all levels.

Our creative team spirit entangles more than forty core staff members: 24 CRAs, 14 Project Assistants, 1 CEO, 1 COO, 1 CFO and 1 QA Manager. Among them: 19 M.D. and 5 M.Sc in Pharmacy.

Comac Medical is also a pioneer in the field of Quality of Life projects in Bulgaria.

The enlargement of our enterprise has brought to the establishment of a 60-bed Clinical Research Unit for Phase I, BA/BE Studies, the biggest one in South-East Europe, located in the center of Sofia, Bulgaria.

Comac Medical’s continuous and dynamic endeavor towards sophistication of trial management is based on strict adherence to the ICH-GCP Guidelines, Bulgarian Law, EU and global regulatory requirements, as well as to the medical ethics.

Our successful development is best represented by the following outline of 10-year experience and expertise:

FDA Inspected Sites
NIH, US Certificate of Recognition
Phase I Clinical Research Unit
1 FDA Pre-IND meeting
ISO 9001:2000

Please visit our company web site: www.comac-medical.com

• Conduct and monitoring of clinical trials (all phases and indications)
• Conduct of BA/BE studies in our own Clinical Research Unit for Phase I, or at selected sites
• Medical writing (Protocol, CRF, ICF design)
• Development and validation of analytical assays
• Biostatistics and data management
• Central pharmacy (drug handling, storage, distribution and destruction)
• GCP training, co-monitoring and independent external QA audits
• Consultancy in regulatory environment for the conduct of clinical trials in Bulgaria, Macedonia, Romania, Serbia and Montenegro
• Quality of Life Projects: translation, pilot testing, proofreading

1. Bioequivalence 2. Cardiology 3. Diabetology 4. Dermatology 5. Endocrinology 6. Gastroenterology 7. Haemodialysis 8. Haematology 9. Infectious Diseases

10. Neurology 11. Nephrology 12. Oncology 13. Obstetrics and Gynaecology 14. Paediatrics 15. Pulmology 16. Rheumatology 17. Urology 18. Vaccine

(up to 1^st September 2007)

• 4 offices on the Balkan Peninsula, covering Bulgaria, Romania, Serbia and Montenegro, Bosnia and Herzegovina, Republic of Srpska and Macedonia
• 10 years experience
• 88 clinical trials
• 68 quality of life projects
• 163 feasibility studies
• 185 principal investigators database
• 177 audits/inspections/co-monitoring visits
• 166 certificates of quality/attendance/recognition and training
• 1 FDA Pre-IND meeting (proof of concept, PoC)
• 2 FDA inspected sites, NIH letters issued
• 6002 patients enrolled
• 2620 monitoring visits (incl. QV, IV and TV)

• Ongoing Company Staff Education and Training

  In order to maintain a high level of clinical research excellence we put a stress on constant staff development initiatives and programs:

  Training Sessions during Internal and External Independent Audits, Internal and External GCP Trainings, Site/Protocol Specific Trainings, Regulatory Compliance and Investigator Seminars, Sponsor SOP Trainings, Investigator Meetings, QMS trainings and daily supervision, as per company SOPs.

  Comac Medical has been the promoter of numerous events related to GCP and regulatory educational initiatives for Bulgarian and Macedonian investigators and independent, regulatory ethics committees.

• Rapid Company Growth and Significant Experience

  Comac Medical is a privately owned Full Service CRO, founded in 1997 by Milen Vrabevski, MD. Due to the successful development of the company and the clinical research enterprise in general, for the region, during the last 10 years our strategic horizon exceeded the boundaries of our country. Bulgaria's strategic position on the Balkans gives opportunity for expanding access towards our neighbour countries.

• Clear Working Procedures

  Comac Medical Ltd. has developed its own SOPs to ensure the accurate performance of study procedures. The upper management is also capable to organize the clinical research process per Sponsor’s or partner’s SOPs, if required. Our competence and flexibility are certified by the positive results of all system and site audits, since the beginning of 2001.

  Comac Medical undertook introduction of Quality Assurance program. The successful development of the QA program achieved a better study performance, featured by good quality practices. It is a proven guarantee for the successful trial accomplishment and reliability of clinical data.

• Strict adherence to ICH GCP
• Regulatory approvals in short terms
• Large number of potential patients with all types of pathology (incl. drug-naive patient population)
• One step to the opinion leaders
• Targeted selection of professional and motivated investigators
• Smooth Import Procedure
• Efficient recruitment strategies
• Quality and reliability of the data
• Adequate data flow within required time frames
• Experienced and trained company staff
• Hi tech office facilities
• Comparatively low costs

Contact Information

Comac Medical Ltd.
Dr. Milen Vrabevski, CEO
131 Odrin St., apt.22
Sofia 1303 Bulgaria
Phone: +359 2 921 19 10
Fax: +359 2 921 19 11
E-mail:

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