At Comac Medical, we offer comprehensive services for the development and clinical evaluation of medical devices and nutraceuticals. Our team provides end-to-end support, from regulatory consulting and clinical trial design to data management and post-market surveillance.
We ensure rigorous testing and validation to meet global safety and efficacy standards. Our bioanalytical laboratory services and robust quality assurance processes guarantee reliable results.
Partnering with us means leveraging our expertise to navigate complex regulatory landscapes and bring your innovative products to market efficiently and successfully.
What We Do:
- Regulatory Consulting
- Clinical Trial Design and Management
- Data Management and Analysis
- Bioanalytical Laboratory Services
- Quality Assurance
- Post-Market Surveillance
CASE STUDY
Medical Device for Women’s Health
Sponsor was a medical device company seeking approval of the Italian Medicines Agency (AIFA) for a Lactobacillus strain present as a medical device formulation for vaginal use. The study represented a full-service solution that spanned protocol design strategy through preparation and submission of the final report.
CHALLENGES:
The device itself posed a unique challenge because it was a novel device that investigated the effect of a bacterial strain on the concentration of IL-6 in vaginal fluid. Investigators had to make sure that the aspiration procedure for collecting vaginal fluid is executed with extreme precision. Also, an appropriate analytical method had to be developed to capture the concentrations of IL-6.
SOLUTIONS:
- The study was conducted in Bulgaria, at 4 sites, involving 210 subjects.
- Comac Medical ensured the deployment of qualified study coordinators at all sites in order to keep strict oversight of the procedure for vaginal fluid collection.
- Through extensive literature review and repeated lab tests, the Comac Medical BioAnalytical Lab developed a sensitive method for detecting even the smallest concentrations of IL-6.
RESULTS:
The study was 7 months in duration from initial discussions to final submission. Comac Medical achieved the full recruitment for the study within 2 months. Due to the meticulous collection of vaginal fluid samples by experienced gynecologists and the sensitivity of the analytical method developed, efficacy of the medical device was successfully demonstrated.
and Medical Progress
At Comac Medical, we prioritize precision and progress in all our clinical trial services. Our commitment to meticulous execution and continuous improvement ensures that your projects achieve their full potential.
Collaborate with us to harness innovative solutions and drive forward the success of your medical research.