Site Management Organization (SMO)
Site Management Organization (SMO)
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.
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
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
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.
