Pre-Site Study Preperation

• Identification of Investigator.
• Completion of study feasibility questionnaire.
• Preparation & compilation trial master file.
• Provisioning and Training of Clinical Research Coordinator.
• EC Submission.

during site preperation

• Patient recruitment support.
• Maintenance & updating and updating a trial master file, subject files and CRF.
• Patient follow-up.
• EC notification & submission of amendments.
• Patient recruitment support.
• IMP management.
• Logistic management.
• Assisting Interim Monitoring visit.
• Resolution of Queries.

site close out

• Resolution of Queries.
• Patient Follow-up.
• Regulatory Compliance & site quality assurance.
• Archival of study documents.