After initial contact from the Client (Sponsor)
Signing Confidentiality and Non-Disclosure Agreement
Receipt of Study Synopsis from the Client
QCS Reviews the Synopsis for Study Specific Requirements
Shortlists Study Sites from QCS Database
Scheduling appointments with shortlisted Sites and Investigators
Meet and Discuss the Investigators the Study Synopsis, their willingness to take up the Study, Patient Pool, Referral Activities and other Logistics
Collate and Compile site responses into a Site Feasibility Grid
Grade and Prioritize selected sites
Including study specific Projections, Timelines and Risk Evaluation and Mitigation Strategy
Keeping the client updated and taking its consent
In the meantime, QCS Medical Writers Team completes essential documents/dossier for submission to the EC and Regulatory (if applicable)
EC and Regulatory (if applicable) Submission and Seeking Permission
CTRI and other Portal Registration
Enrolments and Follow-Ups (Data Entry with QC/QA)
Time-to-time Monitoring
Keeping the Client Updated
Communications with the ECs, Regulatory, Investigator and Client
Clinical Study Report
Manuscript/White paper