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CLINICAL & PRE-CLINICAL

Our dedicated Clinical department is responsible for carrying various phases of Clinical trials for our research molecules including medical devices to ensure the safety and efficacy of our products. For this purpose, we have a team of professionals with rich experience and in-depth knowledge to successfully conduct the clinical trials as per GCP guidelines in approved centers.

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The studies are conducted at well equipped centers following study initiation visits prior to patient recruitment. Our study coordinators schedule monitoring visits during the study period and continually supervise the trial until the study report is finalized.

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As a part of post marketing surveillance, Virchow collects and evaluates safety information on specialized products to safeguard the safety of patients.

Animal Facility:

Virchow is a CPCSEA registered body with an animal facility of 2500 sq.ft. built across 10 acres. The animal house has been designed as per the latest GLP guidelines.

 

The key features of the facility are as follows:

  • Differential pressure zones

  • Air conditioned and filtered air through animal-specific air handling units

  • Clean & dirty corridors with different entry and exit points

  • Separate access for maintenance personnel

  • Seamless flooring and walls

  • Light change control

  • Quarantine room, Fumigation room, Pathology lab & Clinical lab

  • Air Shower, Change Rooms, Wash Rooms, Store Rooms, etc.

 

Equipment:

The major equipment that enables easier conformance to GLPs include:

  • Alfa Biotech Auto Analyzers for haematology & Biochemistry (Wipro Biomed)

  • Dual Door Autoclave

  • ELISA Reader

  • Centrifuges

  • Radix multichannel Scanner

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SOPs & Validation:

The GLP compliance maintained with various standard operating procedures (SOPs) and validation procedures that ensure systematic operations include:

  • SOPs for Transport; Quarantine; and handling; maintenance and disposal (carcass) of animals.

  • SOPs for experimentation and generation & recording of data.

  • Validation procedures for compliance monitoring Temperature, Humidity, No. of air changes, Sterility, Particle counts, Filter integrity, Light intensity, etc.

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