With over two decades of experience as a CRO and SMO company, Comac Medical is well-versed in the complexities of Phase II and Phase III clinical trials. We understand the increasing demands for clinical data, the proliferation of protocols, and the challenges in patient enrollment.
Our extensive expertise allows us to swiftly identify the well-suited investigators and patient population, ensuring enrollment goals are achieved efficiently. We prioritize effective communication, providing continuous updates on your project’s status while diligently adhering to deadlines and budgets.
We offer tailored late phase clinical development solutions and services for new investigational drugs and biologics across various therapeutic areas. Whether you need stand-alone services or a comprehensive full-service solution, we are committed to meeting your specific needs and driving your project’s success.
As your trusted partner, we help you develop the right clinical trial strategy for late phase trials to reduce costs, mitigate risks, and ensure your protocol meets global regulatory requirements.
Recruitment and Retention
We focus on patient inclusiveness by leveraging our access to a diverse population due to our convenient location, which is considered the best in the CEE region. Our strategies help us meet your enrollment targets through prioritizing, which increases trial awareness and maintains engagement.
Managing Your Late Phase Trials
Our well-rounded trial management and design are achieved through a detailed approach, ensuring the timely delivery of your project milestones. We develop and manage a comprehensive Project Management Plan, maintaining control of study execution and risk management with fast identification and communication of potential issues.
CASE STUDY
Clostridium Difficile Infection
A Phase III, randomized, double-blind, active controlled study to compare the efficacy and safety of XXXX for 10 Days With YYYY for 10 Days in the treatment of Clostridium Difficile Infection
CHALLENGES:
- Patient recruitment: Competitive recruitment, in 133 sites from 20 countries with a global target of over 680 patients randomized.Finding sufficient patient population.
- Data analysis: Collecting, properly packaging, and dispatching multiple stool samples. Maintaining specimen stability and preventing degradation of C. Difficile toxin
SOLUTIONS:
- Patient identification: Faced with a challenging indication, we selected only major hospitals in each of the 4 countries falling within our scope, guided by the insight that they are the main source of patients with C. difficile infection.
Based on performing a previous study with a vaccine for the prevention of C. difficile infection where the presence of it was an exclusion criteria, our recruitment specialists had gained valuable epidemiological insights and managed to accurately map the prevalence of the disease, such that we knew exactly where to find the required patient population.
- Data analysis: C. difficile toxin is very unstable. It degrades at room temperature and may be undetectable within 2 hours after collection of a stool specimen. We achieved proper maintenance of stability by deploying a highly competent team of nurses and lab technicians who ensured the speedy and proper processing of samples within the designated time windows.
RESULTS:
Results were also achieved through close collaboration with the sites, CRA permanent availability and level of education, and close interaction of the sites with the patients.
Our expertise and full-service offering, coordinated with our experienced teams of specialists and reliable lab partner with global coverage, provided a winning combination of services that resulted in the recruitment of 252 CDI patients from 20 active sites (best in the study) with average of 12.6 pts. per site vs site projections of 5-6 pts. per site. The study endpoints were met due to the diligent work of our site teams who ensured that samples were processed rapidly and testing was performed within specimen stability time windows.
and Medical Progress
At Comac Medical, efficiency is one of our core values, reflecting our commitment to maximizing productivity and minimizing waste.
We focus on achieving optimal outcomes with minimal time, effort, and resources, ensuring that your projects are completed smoothly and to the highest standards.