Advinus has an outstanding history of bioanalytical method development, validation and sample analysis. We have extended our service platform from discovery and preclinical services to provide clinical bioanalysis of human samples.
The Advinus Bioanalytical team has a proven track record of serving Large Pharma and Biotech for their non-clinical and clinical bioanalytical needs. Data can also be turned-around within 72 hours of receipt of samples (along with preliminary PK analysis, if required) to support exposure-guided dose escalation studies. All logistics are project-managed and we assure you hassle-free service of importing clinical trial samples into India. Studies are performed in accordance with USFDA and EMEA bioanalytical guidelines.
We Can:
- Develop and validate new analytical methods for NCEs using state-of-the-art LC-MS/MS & HPLC instrumentation and achieve sensitivity up to pg/mL levels.
- Validate an existing method already developed in another lab for application to study sample analysis.
- Quantify clinical trial samples for analyte and or metabolite(s) for Phase-I through Phase-III trials.
Case Study: Clinical Bioanalysis support for US based Industry Leader
Challenge:
- Trials were managed by a US based CRO; study performed in continental US
Solution:
- Sensitive method was developed suitable to the low doses in the initial cohorts
- All logistics were worked out. Samples were received at Advinus within 72 hours of sample collection
- Data were reported within 72 hours to enable exposure-guided dose escalation. Interim PK calculations were also provided with the bioanalytical data
