Creative Biolabs® offers comprehensive clinical trial monitoring services from feasibility through site closeout to support clinical trials worldwide. Our global clinical research associates (CRAs) are committed to developing strong site relationships while ensuring compliance with data quality, subject safety, and early issue resolution throughout the course of the trial.

Features:

• Comprehensive monitor plans

• Full-service monitor visits: qualification, initiation, interim, routine, and close-out

• Regulator document collection and management: site records, monitor reports, and regulatory document

• In-country expertise for feasibility or regulatory submissions

• Remote monitoring

• Source document verification

• Query management and resolution support

• Site training and support

• Site management support and documentation

• Regular remote electronic data capture (EDC) review

• Product accountability

Monitoring Strategies

Creative Biolabs employs a customized monitoring approach that consists of a compliance-oriented monitoring process and is designed to take into account each particular project and each study site. Every monitoring plan is tailored to the specific study. The project manager works with you to determine the most effective and cost-efficient monitoring plan, including standard on-site monitoring, central monitoring, risk-based monitoring or a hybrid to meet your project objectives. The results generated by Creative Biolabs are delivered in a timely fashion.

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