Clinical Monitoring Services

The key to successful clinical trials is the efficient management and monitoring of clinical sites. 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.

Creative Biolabs has deployed a number of specialized staff to perform all aspects of site management and monitoring throughout our many operational centers. We aim to limit travel, bolster support for project teams and leverage local knowledge of the clinical research and regulatory environments. Our CRAs oversee the progress of your study to ensure that progress is conducted, recorded, and reported in accordance with the established protocol, keeping in mind a variety of considerations such as the objective, complexity, and endpoints of the study.

Clinical Monitoring Services Include:

• 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

Fig.1 Clinical monitoring services.

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. The multi-site comparisons and centralized data collection allow for the identification of outliers, the early identification of risks and the immediate resolution of site issues.

Some of our clinical site management services include:

• Site identification and selection
• Site feasibility assessments
• Communication with sites
• Development of recruitment criteria
• Managing patient recruitment
• Ongoing site monitoring and management
• Regulatory document collection, review, and management
• Assurance of Good Clinical Practice (GCP)
• Study-specific training to site personnel
• Database lock and study close-out

Creative Biolabs has taken a leadership role in the application of clinical monitoring. Our clinical monitoring services are tailored to your needs. All monitoring activities are conducted in accordance with the study protocol, clinical monitoring plan, standard operating procedures, and applicable regional regulations. If you are interested in our services, please contact us for more details.