Services
Biostudy Services
Clinical
147/F, 8th Main, 3rd Block,
Koramangala, Bangalore – 560034,
INDIA
State-of-the-art facility
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Our Clinical And Bioanalytical Facilities have been inspected/audited by:
FDA, CDSCO (DCGI) India, ANVISA (Brazil), MoH (Turkey), EMA, and WHO.
Studies conducted
Therapeutic Classes
Antibiotics, Anti-diabetics, Anti-hypertensive, Anti-virals, Anti-epileptics, Lipid lowering agents, Diuretics, Muscle relaxants, NSAIDs, Platelet inhibitors, Vasodilators, Phosphodiesterase inhibitors, Anti-Parkinson, Immunosuppressant, Anti-psychotic, Corticosteroids.
Bioanalytical
Our bioanalytical facility is approximately 10,000 sq. ft.
- Qualified, trained & experienced team of bioanalytical professionals
- Method development/validation for proprietary (NCE) and non-proprietary assays
- Bioanalysis of drug and metabolites in a variety of biological matrices
- Ability to develop and validate highly sensitive assays in low pg/ml range
- Ability to accommodate projects with rapid turn-around times
We have the latest 5500 LCMS/MS Bio analytical instrument offering very high sensitivity and the ability to conduct hormone studies etc.
Instrument details:
- 3 LCMS/MS – API 4000 with WATERS UPLC
- 3 LCMS/MS - 5500 Triple QUAD and 5500+
Software:
- Analyst 1.7.2 and 1.7.3 for data processing & Instrument control
- Fully validated and 21 CFR (part 11) compliant
General Aspects:
- Dedicated Archival facility
- Pharmacy with special license to handle restricted drugs
- Access to special population
- Experience in patient biostudies
- Access to multiple trial sites to conduct clinical end point studies
Pharmacokinetics & Biostatistics
We offer:
- Statistical input into the protocol - Sample size estimation, design and analysis plan
- Pharmacokinetics – Planning & execution
- CRF review
- Randomization - Block, stratified, and/or blinded depending upon study design
- Statistical Analysis Plan (SAP) - Preparation in a globally acceptable format
- Statistical analysis – For Biostudies and Clinical Trials (Phase I, II, III and IV) based on pre-defined objective and hypothesis.