As a genuine full-service CRO and SMO, we specialize in Phase I and Bioavailability/Bioequivalence (BA/BE) studies, providing comprehensive and efficient clinical trials management.
To succeed in the early stages of clinical development, a perfectly coordinated effort is essential. This involves anticipating potential challenges, recruiting the right patients and volunteers, engaging top investigators, and designing trials that set a good foundation for success in later stages.
Our strategically located Early Phase Clinical Research Unit and extensive subject database provide us with exceptional patients and healthy volunteers access.
The Clinical Research Unit (CRU) is located in the University and Medical Center in Sofia and offers unparalleled direct access to a network of esteemed Principal Investigators. This strategic location not only facilitates seamless collaboration but also allows us to significantly expand our patient pool. By leveraging these investigators’ patient referrals, Comac Medical is able to accelerate recruitment and enhance the diversity of participants in our clinical trials.
This great advantage has enabled us to consistently achieve top recruitment and retention rates in Europe, where efficiency and speed are crucial in the clinical trials recruitment process.
Our specialized early-phase resources, including clinical pharmacology, Phase I unit, site alliances, bioanalytical laboratories, biometrics, therapeutic and drug development expertise, ensure a comprehensive clinical trials strategy for success.
What We Do
- First-in-Human (incl. patients)
- Proof of Concept
- Dose Escalation (SAD, MAD)
- Bioavailability
- Bioequivalence (incl. patients)
- Biosimilars
- Thorough QT (TQT) Study
- Food Effect
- Drug-drug Interaction
- Microdosing
- ADME
- Pediatric Trials
- Elderly Population Studies
- Hepatic and Renal Impairment Trial
CASE STUDY
Refractory Solid Tumors
A phase I open-label dose-escalating study to determine the safety, tolerability, maximum tolerated dose, and pharmacokinetics of an oral solution in subjects with refractory solid tumors
CHALLENGES:
- Patient recruitment: Finding eligible patients for the trial was a significant challenge. The patient population was limited due to the rarity of the disease and the strict inclusion criteria for the study.
- Data analysis: The trial generated a large amount of complex data that required specialised expertise to analyse, which could have delayed the trial’s completion.
SOLUTIONS:
- Patient identification: Comac Medical partnered with advocacy groups and clinical sites to identify eligible patients for the trial. The company has also introduced an extensive pre-screening procedure to verify that patients align with the study’s inclusion criteria and reduce the screen failure rate.
- Patient safety monitoring: A safety monitoring committee was established to oversee patient safety throughout the trial. The committee reviewed adverse events, provided guidance on dose modifications, and made recommendations on the continuation or discontinuation of the study.
- Data analysis solutions: To analyse the complex data generated by the trial, Comac Medical engaged a team of specialised team composed by Medical Monitors and PK experts combining their expertise to identify trends and data patterns.
RESULTS:
The trial successfully enrolled 36 patients within the targeted timeline. The safety monitoring committee ensured safety dose escalation process based on the observed data. There was not any patients’ datasets exclusion based on the important PD. The maximum tolerated dose of the oral solution was established, providing valuable information for future clinical trials and commercial development.
and Medical Progress
At Comac Medical, we stand as your reliable and committed partner, ready to embrace new projects with enthusiasm, driving innovation within the healthcare industry.
Join forces with us to gain access to top scientists, dedicated medical experts and clinical trial professionals, and benefit from our nearly three decades of global experience, ensuring high-quality service delivery.