Services > Central Reference Laboratory & Biomarkers

Capabilities to handle

• Safety Testing
• Biomarkers
• Pharmacokinetics of Biosimilars including LMWH
• Immunogenicity Testing
• Microbiology testing for Hygiene Studies employing ASTM guidelines
• Project Management for all analytical services with high level of customisation

Experience

• Handling of Phase Trials: Central lab at Lambda has vast experience in supporting late phase clinical trials involving specialties like COPD, CVS, Oncology, Diabetes, CNS, and Orthopedics for Safety and Efficacy
• Pharmacokinetic analysis of Biosimilars, e.g., EPO, Peg GCSF, INF alpha, Bivalirudin, etc.
• Immunogenicity testing for rH EPO
• Validation and analysis of 20+ biomarkers for phase I trials
• Hygiene Studies for antibacterial activities of products from MNC

Services

• Central laboratory Services for Phase trials: Customisation, Investigator Support, Strong Logistical Support and Web based access to reports to Investigators
• Biomarker analysis for Phase I - III trials: Consultancy on selection and analytical services
• Assay Development and Validation using cell based, ELISA and flow cytometry based assays

Accreditations