Pre-Site Study Preparation

• Identification of Investigator.
• Completion of study feasibility questionnaire.
• Preparation & compilation of trial master file.
• Provision and training of clinical research coordinator.
• EC Submission.

during study preparation

• Patient recruitment support.
• Maintaining & 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.

study site close out preparation

• Resolution of queries.
• Patient follow-up.
• Regulatory compliance & site quality assurance.
• Archival of study documents.