When you delegate oversight of your investigative sites for regulatory compliance and patient safety, there is nothing as important as your reputation and success of your research project as choosing the right experienced Monitoring Team to represent you.
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 and assigned to your Monitoring Team.
Our Clinical Monitors or Clinical Research Associates (CRA) receive ongoing training to ensure a comprehensive understanding of their role and to keep current on industry trends. Separately, each CRA receives study specific training to ensure a deep understanding of each protocol and standard operating procedures (SOPs). This ongoing study-specific training ensures 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, and provide site support ensuring 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.
Our Clinical Monitoring services include:
- Investigative site evaluation – Pre-qualification, Pre-study visits.
- Development and implementation of the Clinical monitoring plan
- Interim Monitoring visits
- Close out visits
- Site Training and support visits
Download our brochure to learn more about how we Innovate and Integrate to Execute your clinical trials.