Email : info@gen-biosis.com

Infrastructure Overview

Overview

Infrastructure

  • The facility comprises of 27000 sq. ft. dedicated areas for Clinical, Bioanalytical, QA, Regulatory, PK & Biostatistics.
  • Air-conditioned facility with restricted biometric access control systems.
  • The facility has UPS backup for critical operations and generator power backup for the entire facility.
  • The facility is situated next to Manipal Multispecialty Hospital.

Key Departments

  • Clinical
  • Bioanalytical
  • Quality Assurance
  • Regulatory Affairs
  • Medical Writing
  • Project Management
  • Pharmacokinetics & Biostatistics

Types of Studies

  • Fasting, Fed and Food-effect studies
  • Parallel, crossover, partial replicate and full replicate design studies
  • Long housing studies
  • Multiple dose studies
  • SAD (Single Ascending Dose) studies
  • MAD (Multiple Ascending Dose) studies
  • Proof-of-concept studies
  • Drug-drug interaction studies
  • First in Human studies

Clinical Facility

Volunteer Management:

  • Volunteer registration and management are performed using VPMS (Volunteer Project Management System) software with biometric identification.
  • OVIS (Online Volunteer Information System) software is used for tracking volunteers’ cross-participation across various CROs.
  • Provides real-time tracking of volunteer availability, demographics, and participation history.
  • Maintains secure, audit-ready volunteer records compliant with applicable regulatory requirements.

Clinical facility has a total capacity of 180 beds equipped with bedside alarm systems, distributed across five independent clinics, designed to separately accommodate multiple studies at one point of time, can accommodate male and female studies simultaneously.

  • Clinic I – 34 beds
  • Clinic II – 22 beds
  • Clinic III – 16 beds
  • Clinic IV – 60 beds
  • Clinic V – 48 beds

Intensive Care Unit (ICU):

Fully equipped intensive monitoring facility comprising three ICUs, each having two beds, equipped with cardiac monitors, ECG machines, crash carts, laryngoscopes, defibrillators, nebulizers, suction machines, oxygen cylinders, stretchers, fowler beds and emergency medicines for handling medical emergencies.

Phlebotomy stations connected to the sample processing area with refrigerated centrifuge machines and -80°C deep freezers.

Separate physician rooms for vital signs, physical and clinical examination.

Dining area

Entertainment area equipped with indoor games including carrom board, chess and Ludo etc.

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Pharmacy Unit

 

  • Pharmacy with access control and a temperature alarm system.
  • Walk-in chamber for storage of IPs at 23 ± 2°C and 65 ± 5% RH.
  • Pharmaceutical refrigerator for storage of IPs between 2–8°C.
  • High-sensitive analytical balance for weighing dosage forms such as powders.
  • Laminar air flow for dispensing.

Emergency Services

Associated with Manipal Hospital situated next to GenBiosis Bioresearch, which provide round-the-clock ambulance services for emergency situations.

Bioanalytical Facility

Total 10 LC-MS/MS systems:

  • 7 LC-MS/MS Systems of AB SCIEX Triple Quad – 4500
  • 2 LC-MS/MS Systems of AB SCIEX API – 3200
  • 1 LC-MS/MS System of AB SCIEX Triple Quad – 6500+
  • All of the above instruments are coupled with UHPLC/HPLC systems (Agilent / Shimadzu)

Archival Facility

  • Secure, access-controlled archival facility.
  • A dedicated archivist for retrieval and re-storage of documents.

Important links

About Us

Corporate Social Responsibility

Careers

Contact Us

Services

Bioavailability

Clinical Trial Services

Medical Writing Services

Regulatory Services

Contact

info@gen-biosis.com

Corporate office and BA/BE Centre, Majestic Plaza, Sr. No. 21/5, Near Manipal Hospital, Kharadi, Pune – 411 014, Maharashtra.

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