Genzyme Analytical Services is dedicated to providing specialized platforms to the pharmaceutical and biotechnology industries that enable the innovation and development of the next generation of therapeutics and diagnostics.
Through our core capabilities in preclinical studies and assay development, we offer the key elements critical to new product development - from preclinical trial development through Phase IV. In addition, we can partner in the development of products from early development and validation through regulatory approval and launch.
- Diagnostic assay development
- Cross-reactivity testing
- Eligibility criteria for clinical trials
- Validation of existing tests to meet your clinical trial requirements
- Transfer of technologies for implementation during your clinical trials
To learn more about Clinical Trials & Test Development, please call 866-447-4409 or
email Genzyme Analytical Services.
Technologies & Capabilities
As part of Genzyme Genetics, Genzyme Analytical Services has access to the technologies and services of the largest independent provider of genetic testing in the United States.
Clinical Trials
Our clinical trials unit serves the clinical trial pathology needs - handling both large and small trials - for the pharmaceutical and biotechnology industries.
We develop new assays, validate existing ones for clinical trial use, and assist in the development of companion diagnostics.
Providing each client with high quality services and results is of the utmost importance. We take great care in supporting the logistics of each clinical trial, including:
- customizing each trial for the needs of a specific client
- collecting data to answer key questions
- tracking the status of each sample
- assisting in the final analysis
All work is done in compliance with GLP/GCP, CLIA and CAP regulations.
Preclinical Development
Our preclinical development unit serves the preclinical needs of the pharmaceutical and biotechnology industries.
We develop and validate tests using novel & commercially available markers for possible clinical trial testing or for research purposes.
In addition, we oversee protocol development, assess technological resources and, when necessary, support the regulatory approval process.
We ensure that our studies are fully validated and of the highest quality. All work is done in compliance with GLP/GCP, CLIA and CAP regulations.