When you delegate oversight of your investigative sites for regulatory compliance and patient safety, there is nothing as important as your reputation and the success of your research project. Choosing the right experienced Monitoring Team to represent you is of utmost importance.
At Clinlogix, we take this responsibility very seriously. We understand the importance of establishing excellent working relationships with the investigative sites. It is more than just assuring that the conduct of the clinical trial is according to the clinical protocol, applicable regulations, state and local laws, and Good Clinical Practice. Our knowledgeable trained professionals are carefully selected before being assigned to your Monitoring Team. They put in the time to develop and make the commitment to maintain good working relationships with each site.
Our Clinical Monitors or Clinical Research Associates (CRA) receive ongoing training to ensure a comprehensive understanding of their role and are kept up-to-date with the latest information on current and upcoming developments in the industry. Each CRA receives individual, study-specific training to ensure a deep understanding of every protocol and a thorough commitment to follow all standard operating procedures (SOPs). This ongoing, study-specific training ensures that each CRA is an expert on each project.
Clinlogix CRAs are dedicated to an average of two (2) projects at a time; the objective is to provide them with the time to focus on process excellence, fully understand the protocol, the medical background and provide site support which ensures site compliance. The Monitoring Team’s reporting structure is simple and transparent, allowing for appropriate oversight and support to ensure accountability and success of each CRA by following the highest working standards. Project managers and CRAs take the time to discuss site-specific findings and provide guidelines on what and how to follow-up consistently.
Our Clinical Monitoring services include:
- Investigative site evaluation – Pre-qualification, Pre-study visits
- Site Initiation Visits – collecting of necessary documents for submissions, activation of sites – study specific and on completion of monitoring activities
- Development and implementation of the Clinical monitoring plan
- Interim Monitoring visits – recruitment, eligibility, informed consents, validation and verification of collected data, accountability, review of Investigator Site Files
- Review AEs/SAEs reporting procedures
- Close-out visits
- Site Training and support visits
- Remote monitoring