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Clinical Trials and Regulatory Expertise

At Cmbio, we understand the complexities of conducting clinical trials, especially when it comes to microbiome research. Our regulatory expertise and commitment to high-quality standards ensure that we provide reliable and compliant data to support your clinical trials - from early-phase studies to post-market follow-ups. Whether you are conducting trials in Europe or the U.S., we have the infrastructure, expertise, and certifications to meet the most stringent regulatory requirements.

 

Clinical Trials and Regulatory Expertise

At Cmbio, we understand the complexities of conducting clinical trials, especially when it comes to microbiome research. Our regulatory expertise and commitment to high-quality standards ensure that we provide reliable and compliant data to support your clinical trials - from early-phase studies to post-market follow-ups. Whether you are conducting trials in Europe or the U.S., we have the infrastructure, expertise, and certifications to meet the most stringent regulatory requirements.

 

Our Expertise in Clinical Trials and Regulatory Compliance

We offer a range of regulatory-compliant services designed to support clinical trials in the microbiome space, ensuring that your data is robust, reliable, and compliant with regulatory standards.
 

CLIA-Certified Metagenomics Pipeline

 Our U.S. lab is CLIA-certified, meaning we can deliver high-quality metagenomic data for clinical trials with the certification needed for regulatory submissions. This certification ensures that our processes meet the rigorous standards required for clinical laboratory testing.

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ISO 17025 Audited Lab and QMS

In Denmark, our lab and Quality Management System (QMS) are ISO 17025 audited, providing an additional layer of quality assurance for our microbiome analysis services. This standard ensures that we maintain a high level of accuracy, reliability, and consistency in all laboratory processes, making our data suitable for regulatory submissions in Europe, US, and beyond.

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Qualified Labs and Computational Platforms

We to generate data in a qualified lab and analyze that data on a qualified computational platform. This process fully complies with GxP requirements, providing the highest level of assurance for data integrity and quality. In addition, we can conduct study-specific method validationtailored to your clinical trial needs, ensuring compliance with regulatory standards at every step of the process.

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Experience in Phase 1, 2, and 3 Clinical Trials

We have extensive experience working on clinical trials, including phase 1, 2, and 3 trials. Our team has supported trials in both Europe and the U.S., providing microbiome data and analyses that have been critical in shaping study outcomes. With several ongoing and upcoming trials, we are equipped to handle the unique challenges that arise in microbiome-related clinical research.

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Study-Specific Method Development

We offer customized method development and validation tailored to the specific needs of your clinical trial. Whether you're developing microbiome-based therapies and probiotics or investigating the role of the microbiome in disease, we ensure that our methods meet the regulatory requirements for your specific study.

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Bacterial Isolate Characterization for Regulatory Compliance (EFSA, FDA, and Global)

We offer whole-genome sequencing (WGS) of bacterial isolates, providing detailed characterization of antimicrobial resistance (AMR) genes, virulence factors, and metabolic pathways. This service supports regulatory compliance with global bodies such as the European Food Safety Authority (EFSA), the U.S. Food and Drug Administration (FDA), and other international regulatory agencies. Our comprehensive reports include genomic data required for safety assessments, regulatory submissions, and market approvals for probiotics, human therapeutics, and feed additives. This service ensures that your products meet the rigorous safety regulations required for global market entry.

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