Clinical Monitoring
ICRC-Weyer provides qualified Clinical Monitoring to assist in achieving protocol and regulatory compliance for a timely delivery of high-quality data. We provide our service to pharmaceutical or biotech companies, universities or individual investigators acting as sponsors in clinical trials. Apart from drug trials, these may include studies for the evaluation of diagnostics, medical devices, and advanced therapies.
Our strong focus on the sponsor’s specific needs and the requirements of the individual study results in our strategy of involving the Monitoring team as early as possible in a trial, to help in all stages from planning and development to conduct and finalisation.
All members of our Monitoring team are intensively cross-trained with the other departments, especially Data Management, Medical Review and Medical Writing.
Monitoring cooperates closely with Medical Writing for the purpose of handling regulatory affairs.
Monitoring Services:
• Pre-study & Initiation visits including reports
• Interim Monitoring & Close out visits including reports
• Source Data Verification
• Trial document handling including Investigator Site File maintenance
• Reporting of safety information
• Training of investigators and study personnel
• Administrative tasks
