Bioanalysis to Support Clinical Research
CMIC US Clinical Bioanalysis
Bioanalysis Solutions to Support Clinical Research
At CMIC Inc., we understand the critical importance of the clinical research phase in drug development. This phase is pivotal in determining the safety and efficacy of pharmaceutical products before they can be brought to market.
What Happens During the Clinical Research Phase?
The clinical research phase involves rigorous testing of investigational drugs or medical devices in human subjects. It is typically divided into three main stages:
Phase I: This phase involves testing the investigational product in a small group of healthy volunteers to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics. The primary goal is to establish the initial safety profile and determine the appropriate dosage range for further testing.
Phase II: In this phase, the investigational product is administered to a larger group of patients with the target disease or condition. The focus is on assessing the product’s efficacy and further evaluating its safety profile. This phase helps researchers gather preliminary data on the product’s effectiveness and potential side effects.
Phase III: Phase III trials are large-scale studies involving hundreds to thousands of patients. The primary objective is to confirm the efficacy and safety of the investigational product compared to existing treatments or a placebo. Data from these trials is crucial for regulatory approval and informing clinical practice.
How CMIC Inc. can support your clinical phase projects
At CMIC Inc., we offer comprehensive bioanalytical support services to streamline your clinical phase and ensure the success of your drug development program. Our bioanalytical services include:
- Assay Development and Validation: We develop and validate bioanalytical methods tailored to your specific drug compound, ensuring accurate and reliable measurement of drug concentrations in biological samples. For large molecules, we can develop and validate assays for detection of anti-drug antibodies and neutralizing antibodies.
- Sample Analysis: Our state-of-the-art laboratories and experienced scientists perform sample analysis with precision and efficiency, meeting the highest quality standards.
- Data Management and Reporting: We provide comprehensive data management solutions, including data analysis, interpretation, and reporting, to support your regulatory submissions and decision-making processes.
- Regulatory Compliance: Our team is well-versed in regulatory requirements and guidelines, ensuring that your bioanalytical studies meet the necessary compliance standards for regulatory submission. We can assist in responding to feedback from regulators based on our extensive experience with programs that went the distance to drug approval and beyond, to post-marketing commitments.
