CIDAL offers Clinical Monitoring services through our team of experienced Clinical Research Associates (CRAs) fully trained in ICH-GCP guidelines and local regulations. All staff receives ongoing training relating to the basic principles of clinical research, subject protection, as well as key project procedures.
Monitoring activities include pre-study visits to sites, site initiation, interim clinical monitoring and close out visits. CIDAL takes a proactive approach to issue identification and resolution, as well as site management supervision, employing extensive experience in Electronic Data Collection, Case Report File systems and Standard Operating Procedures.
Other important tasks completed in Clinical Monitoring are:
- Verification of site staff adequacy during study
- Verification of adherence to protocol, ICH-GCP and local regulations
- Informed consent process
- Principal investigator management
- Ensuring that site personnel are always informed with pertinent study information
- Recruitment & enrollment status
- Adverse event reporting and management
- Investigator’s file review / availability of essential documents
- SDV according to Sponsors requirements
- Adequacy of source documents
- Accurate and complete study records
- Data quality
- Overall site performance