Dr. Milen Vrabevski, CEO
Comac Medical, with an experience of over two decades, is a premier provider of clinical trials to pharmaceutical and medical device industries fostering the development of new medical therapies. The company has built a vast network of investigator sites and secure access to specific patient pools, as well as a large healthy volunteer database. Together with Comac’s motivated and experienced team, the company provides clients with fast recruitment and quality data. “We have full-service capabilities resulting in cost and process effectiveness, which is why our repeat business rate is above 70 percent,” says Dr. Milen Vrabevski, CEO of Comac Medical.
Comac provides a broad range of clinical research services from the conduct of clinical trials phase I-IV BA/BE, central laboratory services, interventional Phase I/II/III & IIIb/IV and non-interventional trials, patient recruitment, project management, and medical writing. In addition to having a full-service offering, Comac operates a fully equipped unit for Phase I, BA/BE Studies in Sofia with 42 hospital beds and 24-hour emergency care along with clinical and bioanalytical laboratory. The unit is powered by a highly dedicated medical and operational team to carry out clinical trials effectively and efficiently. “Our local CRA can communicate and conduct activities by minimizing local cultural and administrative hurdles. In addition, we can easily reallocate additional support of CRAs, project leaders, regulatory advisers, and many other clinical research specialists, as our business model is flexible and adaptive to the client’s needs,” explains Dr. Vrabevski.
Boasting of a sustained reputation of quality and timely delivery, Comac has clients across Europe, U.S., Japan, and Canada. In an instance, Comac recently carried out a challenging study in pediatric asthma with an objective to demonstrate the therapeutic non-inferiority of the bronchodilator responses over 12 hours.
We have full-service capabilities resulting in cost and process effectiveness, which is why our repeat business rate is above 70 percent
Comac leveraged its intensive pre-screening activities focused on the eligibility requirements as well as on the PFT data during the last 12 months. The company helped with the selection of PI with a significant pool of patients and experience in pediatric early phase clinical trials. In addition, the company offers extensive expertise in hepatic and renal impairment trails with six and 12 trials respectively over the last few years. “Maintaining extensive expertise in various therapeutic fields such as oncology, cardiology, neurology, rheumatology, and endocrinology is our key driver,” says Vrabevski.
To strengthen its CRO services, Comac recently collaborated with Health Decisions, Inc., a leading full-service women’s health specialty CRO. “We were delighted at the expansion of our strategic alliance with Health Decisions for the conduct of clinical trials in women’s health.” With this strategic alliance, the company will provide biopharma companies with comprehensive clinical development services for women’s health products in Europe and the U.S. “These regions offer advanced regulatory environments and both the funding and the investigational sites for most of the world’s clinical trials,” extols Vrabevski.
Comac has also formed a spin-off branded International Research Network (IRN) which is less than three years old with an aim to address the high need for implementing efficient patient sourcing techniques and speed up recruitment of patients and subjects. “IRN manages the clinical trial sites to ensure faster recruitment, rapid start-up, and quality of the study data and offers tailored solutions wrapped around the study requirements,” quips Dr. Vrabevski. In keeping with its spirit of innovation, Comac will continue to provide specialized services for clinical researches with its highly talented resource pool. “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,” he concludes.