Services

Phase I

Clinsys® provides a variety of services within the Phase I stage of testing. These include, but are not limited to, bioanalytical method development; bioavailability (BA), bioequivalence (BE) and pharmacokinetic (PK) studies; food effect studies; and toxicology analysis.

Clinsys Clinical Research, Ltd., located in Noida, India, has a modern, GCP/GLP compliant, 62-bed Clinical Pharmacology Unit and Bioanalytical Facility that performs clinical PK studies and bioanalysis of human biological samples for sponsors making regulatory filings to the FDA, the EMEA, the DCGI and Health Canada. Additionally, Clinsys provides services for Phase I clinical and healthy volunteer studies.

Clinsys provides its sponsors with services for Phase I studies of all types, combining our in-house expertise with selected Phase I units throughout the United States and Canada.

Bioanalytical Capability

Clinsys provides bioanalytical method development, validation and transfer from its Good Laboratory Practice (GLP) facility.

  • LC-MS/MS, HPLC and dark labs
  • Wet lab equipped with refrigerated centrifuges, airshaft free micro and analytical balance areas, Milli Q water system, fume hoods
  • Sample storage with -80° C deep freezers
  • 21 CFR Part 11 compliant software
  • Uninterrupted power supply
  • PK and statistical capability
  • WinNonlin® and SAS®

BA / BE / PK Studies

Clinsys Clinical Research, Ltd., undertakes BA and BE studies per ICH-GCP and FDA guidelines. Clinsys specializes in conducting BA/BE studies under fed or fasting conditions, as well as steady-state PK studies. Clinsys' state-of-the-art 62-bed facility in Noida, India, has its own path lab, clinical, bioanalytical, PK, statistical and quality assurance units under one roof. We provide single or multiple dose BA/BE studies for generic and new drug delivery systems, from protocol development through final clinical report.

Good Clinical Practice (GCP) Compliant Facility

Our GCP compliant facility provides:
  • 62 beds and intensive care unit
  • Calibrated and synchronized clocks
  • Pharmacy with humidity chambers and refrigerators
  • 24-hour ambulance and doctor availability
  • Multi-specialty hospital nearby for emergency care
  • Secure IT infrastructure with BCP and disaster recovery
  • Experienced internal Quality Assurance team
  • External Quality Assurance programs for path lab
  • ISO15189 Certified clinical path lab