Services >> Clinical Operations

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The Clinical Operations group comprises of Clinical Research Associates, Clinical Trial Assistants and Project Managers. The core responsibility of this group is to monitor sites to ensure collection of clinical data that is ICH GCP, Protocol and any other applicable guideline compliant.
Equipped with Masters in Life Sciences and Pharmacy, team members are trained intensively in ICH-GCP guidelines, Roxaane's and other applicable SOPs, and Protocol before being assigned a study.

Roxaane services include

Feasibility assessment

Site Qualification Visits

Submission and Approval from DCGI for trials in India

EC submissions and approvals

Site Initiation Visits

Routine Monitoring Visits

Investigational Product and Materials accountability

Source document verification and tracking and review of completed CRFs

GCP, SOP and Protocol compliance at site

Site Closeout Visits

Effective study conduct and management of sites