Site Management and Monitoring

In clinical research, you need a trusted team to deliver end results that will confidently inform your future development decisions. Our clinical research associates (CRAs) are continuously trained in clinical trial monitoring procedures, ICH-GCP, regulatory issues, therapeutic-specific knowledge and company SOPs. From qualification and initiation through to close out, our CRAs are focused on continually ensuring your study is executed at each site with unparalleled quality. Our team of CRAs works collaboratively with each of your sites to deliver high-quality data by applying our procedures and tools in compliance with all applicable local and regional regulations.

Broad Geographic Coverage

Our clinical monitoring and site management services can help you conduct clinical trials around the world while maintaining consistent, high-quality results. Our CRAs are a blend of regionally-based and office-based employees covering the EU and North America.

For additional coverage, we provide services through well-qualified regional partnerships.

Our CRAs are assigned regionally to monitor where they are able to communicate fluently in the local language, with a keen understanding of the culture and regional requirements.

Therapeutic Expertise

We provide a knowledgeable team of experts who understand the intricacies of the therapeutic area and the investigational drug profile. Our CRAs have experience in a wide variety of indications and therapeutic areas, including:

• Viral infections and infectious diseases
• CNS diseases and pain
• Cardiovascular diseases
• Respiratory diseases
• CNS diseases
• Rare diseases
• Oncology
• Dermatology

Clinical Site Management

Our CRAs are the primary point of contact with the clinical sites, and as such, are experts at relationship management. We are committed to a well-balanced CRA workload, reflected in the limited number of protocols and sites each CRA is assigned, as well as the percentage of time spent travelling. This emphasis enables us to provide you with:

• High-quality data
• Comprehensive understanding and in-depth focus on your program
• Good clinical site relationships

Efficient Site Management and Monitoring Tools

All monitoring activities are managed through our state-of-the-art clinical trial management system (CTMS), which is also accessible to sponsors via the internet. The CTMS provides you with 24-7 access to the latest information. We also use this tool internally to monitor key performance indicators at the management level, allowing us to make adjustments in real time.

With over 40 years’ experience in clinical research, we offer you unrivaled expertise in clinical monitoring and site management for clinical trials.

To discuss your clinical monitoring and site management requirements, contact us today.