Services

Biostudy Services

Clinical

147/F, 8th Main, 3rd Block,
Koramangala, Bangalore – 560034,
INDIA

State-of-the-art facility

  • 72 beds
  • Screening Area
  • Subject Housing Area
  • Blood Draw & Sample Processing Area
      
  • Dining / Recreation Area
  • 2 bed ICU
  • Deep Freezer and Sample Storage Area
  • Dedicated Pharmacy
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
  • 1 LCMS/MS -  5500 Triple QUAD
Software:
  • Analyst 1.6.2 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.

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