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Early Phase Clinical Research Unit

Early Phase Clinical Research Unit

CRO Services SMO Services Early Phase Clinical Research Unit Functional Service Provider (FSP)

Introducing Comac Medical’s Early Phase Clinical Research Unit (CRU), where over 18 years of expertise in Phase I, Bioavailability and Bioequivalence (BA/BE) studies meet state-of-the-art facilities. Strategically located in Sofia, Bulgaria, our Phase I Unit is the finest in Europe and largest in Southeastern Europe.

Advanced Facilities for Early Phase Clinical Trials

Our early phase CRU at the University and Medical Center in Sofia provides us with direct access to Principal Investigators, enabling us to expand our patient pool through their patient referrals to Comac Medical.

Our Phase I Clinical Trial Unit includes a skilled team of physicians, nurses, and specialists, enabling efficient management of clinical trials, including a 24-hour service and weekend PK sampling. Our skilled team of professionals are highly dedicated and prioritize patient safety and care. The unit’s expertise in structured processes allows for parallel studies without compromising procedures, ensuring dedicated resources and seamless execution.

Our fully integrated early phase clinical trial development services drive the success of your early phase trials with faster study initiation and competitive pricing.

With over 300 successful studies, Comac Medical is your trusted partner for clinical research excellence!

DOWNLOAD EARLY PHASE CRU BROCHURE

Strategic Advantages of Our Phase I Clinical Trial Unit

Expertise & Specialization

Our clinical trial unit’s sole focus on early-phase trials equips us with deep expertise to address the unique challenges of Phase I, Bioavailability and Bioequivalence (BA/BE) studies. This specialized knowledge enables us to optimize trial design, ensure flawless execution, and rapidly troubleshoot any issues. Sponsors benefit from quicker trial outcomes and confident, data-driven decisions, accelerating the path to clinical success.

Accelerated Timelines

At Comac Medical, the swift activation of trials is a top priority. Our unit’s internal processes eliminate the need for time-consuming site contract negotiations, allowing us to streamline study setup and start patient enrollment immediately after approval. This integrated approach ensures sponsors can kick off trials faster, minimizing delays and shortening the journey to market.

Rapid Patient Enrollment

Leveraging our extensive clinical trial network and dedicated SMO capabilities, Comac Medical delivers industry-leading patient enrollment speed. Our direct access to a vast patient pool through Principal Investigators allows us to quickly recruit the necessary participants, ensuring your study achieves its enrollment targets faster than competitors, thus accelerating the trial’s progress and reducing delays.

Collaborative Support

While our Phase I Unit operates independently, it is backed by cross-functional teams across Comac Medical. This collaboration ensures seamless communication between departments, such as regulatory affairs, biostatistics, and medical writing, to provide sponsors with comprehensive study oversight and cohesive reporting. The result is a more informed, efficient, and successful trial process.

Independent Structure

Our clinical trial unit maintains operational independence from our CRO team, ensuring that decisions are made with the utmost scientific integrity. This clear separation eliminates any potential conflicts of interest and allows our unit to prioritize the success of each trial based solely on clinical objectives and sponsor needs.

Parallel Conduct of Trials

With a highly skilled and well-resourced team, our Phase I unit is fully equipped to run parallel studies without compromising quality or study outcomes. This operational flexibility ensures that trials, whether overlapping or complex, are conducted smoothly with dedicated teams, 24/7 monitoring, and meticulous resource allocation—guaranteeing uninterrupted progress and precision.