CCRE will provide assistance to sponsors as well as PIs in all aspects of clinical trials, right from pre-trial review through study close out, to ensure that the research is being conducted in compliance to GCP guidelines. This will include, but is not limited to:

  • Identifying suitable PI for the trial
  • Sponsor-PI Liaison
  • Pre-site visit co-ordination
  • Eligibility determination
  • EC submission
  • DCGI approval
  • CTRI registration
  • Consent document
  • Preparing SOPs
  • Compliance with sponsor form and IRB guidelines
  • Specimen/ Sample/ Investigational Product coordination
  • Interim data management
  • Audits and Monitoring

The activities highlighted in red will be provided free of cost. Other clinical research activities can be extended to the sponsor on chargeable basis.