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Infrastructure
The Synapse Facility is located in Pune a growing IT & Biotech centre of India. The clinical facility is designed to meet world-class specifications and diverse client requirements. All studies are conducted in strict compliance with regulatory standards such as GCP, GLP & global regulatory requirements. Best in class peoples are selected to handle these activities.
 
 
42-beds spread across two independent clinical units with separate phlebotomy, dining, recreation and clinical investigation areas.
 
Specialized 2 bedded ICU (Intensive Care Unit) facility with MAC1200 ECG machine, pulse oximeter, defibrillator with monitor for handling emergencies during study.
  GMP Humidity chamber in access controlled pharmacy for the storage of investigational products.
  Bioanalytical lab equipped with HPLC and LC-MS/MS for estimation of drugs and metabolites.
  Deep freezers (- 400C & -800C)
 
21 CFR part 11 compliant temperature and humidity data logger connected with all deep freezers having audiovisual alarm for immediate action.
  GLP compliant facility.
  SAS base SAS /GRAPH, SAS /STAT version 9.1.3 software for statistical analysis.
  WinNonlin for PK analysis.
  Fire proof limited access archival on shore and off shore facility.
  Complete data security, Secured internet with firewall & optimized data storage.
 
  Key Milestone
 
  Completed more than 80 BE studies for domestic as well as international pharmaceutical clients.
  Submitted a pivotal study for EU with no query from regulatory for data submitted to France in query list.
 
Successfully completed Clinical Data Management and Biometrics project for Johnson and Johnson involving 2700 patients.
 
Strategically tied up with Getz Pharma Research, a US based formulation CRO as the only centre for its pilot and pivotal studies.
  Facility Tour
 
       
Front View Entrance Reception Floors
       
Workstation Conference Room Volunteer Waiting Area Registration
       
ECG Pharmacy Clinical Unit Dining Area
Entertainment ICU Bioanalytical Laboratory Laboratory
Balance Room Deep Freezer Sample Separation Area Sample Processing
Sample Analysis Nitrogen Evaporator LC-MS/MS Lab Quality Assurance
 
 
 
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