Clintech Research helps its clients identify qualified investigators/sites, in diverse therapeutic areas, that are spread across India. We perform feasibility studies for sponsors and conduct our own internal feasibility review for each new project based on patient demographics and site capabilities.

Clintech Research coordinates and manages the studies at the sites, assist sponsors in resolving problems with the site, and oversee site activities. Our site monitors work closely with the data management team. Clintech Research site monitoring services include:

• Site selection and investigator enrollment
• Pre-study document collection and review
• Site initiation and training
• Monitoring of patient enrollment rate
• Source document verification & Site Visit Reports
• Data query management
• Drug accountability
• Site close out

Clintech Research provides local representation in India to our global clients who do not have their offices in the country. To support global clinical trials, we coordinate the following activities in India:

• Regulatory permission from DCGI to start clinical trials in India.
• Protocol & related documents submission to Central Ethics Committee for approval.
• Approval of investigator packets required for the release of investigational product.
• Import/export license approval.
• Regulatory submission for drug approval in India.