Piramal Clinical Research (formerly known as Wellquest Clinical Research) has a state-of-the-art facility spread over 30, 000 sq ft at Hyderabad, India.

Clinical

Piramal Clinical Research has three clinical pharmacology units (CPUs) that house 103 beds with monitoring stations and phlebotomy stations, separate dining areas, and recreation areas.

Salient Features

  • 103-bed state-of-the-art facility
  • Equipped with nurse calling system
  • Equipped with sodium vapor lamps (for light-sensitive drugs)
  • 4-bed ICU
  • Tie-up with multi-specialty hospital
  • State-of-the-art pharmacy
    • Restricted biometric access
    • Equipped with normal and walk-in humidity chambers
    • Refrigerators with temperature controllers and 21 CFR compliant data logger
    • Strict monitoring of environmental conditions (temperature and humidity)

Piramal Clinical Research uses WinNonlin (version 5.2.1) and SAS (version 9.2) for pharmacokinetic and statistical analysis. Piramal Clinical Research has a dedicated team with capabilities to prepare study reports in ICH-E3 format as well as has capabilities for e-CTD submission.

Piramal Clinical Research Advantage

  • Database of over 4300 healthy human volunteers
  • Biometric-based software for volunteer registration
  • Protocols reviewed by OHRP (Office for Human Research Protections) registered Independent Ethics Committee
  • Principal Investigators trained in Advanced Cardiovascular Life Support course certified by American Heart Association
  • Nutritionally standardized meals for study participants

Bioanalytical

The bioanalytical team at Piramal Clinical Research has developed and validated over 125 bioanalytical methods. Piramal Clinical Research has expertise in method development, validation and bioanalysis of generic molecules as well as new chemical entities (Phase I-III).

Highlights

  • Equipped with analytical equipment including API 4000 LC-MS/MS, API 3000 LC-MS/MS, API 2000 LC-MS/MS and Shimadzu HPLC Systems
  • Equipped with sodium vapor lamps (analysis of light-sensitive drugs) and fume hoods
  • Deep freezers (–70ºC and –20ºC) for sample storage
    • Fitted with an alarm system for detecting temperature deviations
    • Connected with on-line data monitoring system i.e. data loggers with 21 CFR Part 11 compliant software

Click here for a list of validated methods.

Facility

Facility

Piramal Clinical Research has a state-of-the-art facility spread over 30, 000 sq ft at Hyderabad, India...

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