Site Management Organization (SMO)

KLE Academy of Higher Education &  Research Belagavi

Site Management Organization (SMO)

 

KLE Academy of Higher Education &  Research

Site Management Organization (SMO)

provides clinical trial related services to a contract research organization (CRO), pharmaceutical company, biotechnology company and  medical device company  . Which  has adequate infrastructure and staff to meet the requirements of the clinical trial protocol.

SMO also perpetrate as a service provider for investigators at our  hospital, towards  all spheres of implementation of clinical trials.  Use of a SMO can also help the investigator conce

KLE Academy of Higher Education &  Research

Site Management Organization (SMO)

Standard Operating Procedure

SMO has state of art facilities

  • Independent workstations,
  • ICT enabled Meeting room
  • Chairman and Member secretary office
  • Access control entry to office
  • IP based CCTV coverage
  • Fire safety and some detectors
  • CFR Part 11 compliant IMP Storage facilities
  • Independent network with high speed internet

Registered IMP storage and dispensing Pharmacy

  • SMO houses a licensed research pharmacy for receipt, storage, dispense of IMP, with centralized digital temp logger
  • Registered Pharmacist to provide Blinded or Unblinded services
  • Access control entry to research Pharmacy

A dedicated Archival room with  

  • Rolling Stack Shelving on Rails System with independent locking facilities
  • Access control entry
  • Fire safety and Smoke detectors

In efforts of making paper less office SMO  has subscribed for

  • PATH & CDSA-eEC Software- installed and actively using
  1. Committee

smo-slider

KAHER site has under gone USFDA and CDSCO audits with minimum or nil findings

As a part of professional commitment  , regular workshops are conducted for updates in clinical research, ICH and Good Clinical Practice {GCP} certification, to provide a sound knowledge and training for the clinical research team.

Apart from regular conduct of workshops KAHER conducts full time MSc Clinical  research course to empower the clinical trial profession and augment the lack of trained manpower.

To support all these activities and regulatory requirements KAHER has  CDSCO Registered Institutional Ethics Committee which is accredited by NABH and FERCAP indicating a quality commitment towards the same, Majority of the IEC members  are CITI and NPTEL certified for ICH and GCP guidelines