Workflow

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 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