Clinical Trial Analytical Precision Testing
Within the pharmaceutical testing sector, precision in analytical methods is paramount. Clinical trial analytical precision testing ensures that the data generated during clinical trials accurately reflects the drug's efficacy and safety profile. This service focuses on providing laboratories with unparalleled accuracy through rigorous testing methodologies, ensuring compliance with international standards such as ISO 17025 and Good Laboratory Practices (GLP).
The primary goal of this service is to support pharmaceutical companies in obtaining reliable data that can be used for regulatory submissions. Precision in analytical methods directly impacts the success of a drug candidate by minimizing errors that could lead to incorrect conclusions about its safety or efficacy.
Our laboratories employ state-of-the-art equipment and methodologies, including high-performance liquid chromatography (HPLC), mass spectrometry (MS), and other advanced techniques. These tools allow us to perform complex analyses with minimal variability, ensuring that the results are consistent across multiple samples and trials.
The precision of these tests is crucial for several reasons:
- To ensure the accuracy of dosing in clinical trials,
- To identify potential contaminants or impurities,
- To assess the stability of drug formulations over time.
Our services encompass a wide range of tests, from simple concentration measurements to more complex multi-parameter analyses. Each test is conducted according to stringent protocols designed to minimize error and maximize precision.
In addition to our analytical capabilities, we also offer comprehensive support for method development and validation, ensuring that the methods used in clinical trials are robust and reliable. This includes developing new assays as well as validating existing ones against international standards such as those set by ICH Q2 (R1).
Our laboratories have extensive experience working with various types of samples, including biological matrices like plasma or serum, as well as pharmaceutical formulations ranging from small molecules to biologics. We use a variety of techniques tailored to the specific requirements of each sample type.
Industry Applications
| Application Area | Description |
|---|---|
| Drug Development | Evaluation of drug stability and efficacy in various stages of clinical trials. |
| Regulatory Compliance | Supporting submissions to regulatory bodies like the FDA, EMA, and others. |
| Safety Assessment | Detecting impurities that could pose risks during clinical trials. |
| Pharmacokinetics | Analyzing how drugs are absorbed, distributed, metabolized, and excreted in the body. |
Quality and Reliability Assurance
We maintain strict quality control measures to ensure that every test performed meets or exceeds industry standards. Our laboratories are fully accredited under ISO 17025, which provides assurance of competence to perform specific types of laboratory tests.
- Regular calibration and maintenance of all instruments,
- Dedicated quality control personnel,
- Stringent validation procedures for new methods.
- All tests are conducted in accordance with Good Laboratory Practices (GLP),
- We use advanced statistical tools to analyze data and ensure precision,
- Our personnel undergo continuous training to stay abreast of the latest developments in analytical chemistry.
International Acceptance and Recognition
The results from our clinical trial analytical precision testing are widely accepted by regulatory agencies around the world. By adhering to international standards such as ISO, ICH guidelines, and others, we ensure that our work meets global expectations for quality and reliability.
Our laboratories have been recognized by multiple national authorities and international organizations. This recognition underscores our commitment to excellence and provides peace of mind for pharmaceutical companies seeking reliable data from their clinical trials.
