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| Clinical Trial Monitoring |
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Our Clinical Trials Services team provides clinical monitoring and management of the investigative site and is the main line of communication between the sponsor the investigator clinical site.
On site monitoring - Before, during and at close out of clinical trial.
Focus: To make sure that the clinical site has:
- Good control over the study
- A smooth patient recruitment process
Ensure:
- The rights and well being of human subjects are protected.
- The data are accurate, complete, and supported by source documentation.
- The conduct of the trial is in compliance with the approved protocol, with Good Clinical Practices, and with the applicable regulatory requirements.
Monitors:
Clinical monitoring and site management are conducted by top of the line Clinical Research Associates (CRAs), or monitors, who are knowledgeable of:
- The disease, pathology, protocol, the investigative product.
- Informed consent and written information provided to subjects.
- The sponsor's Standards of Practices, Good Clinical Practices, and the applicable regulatory requirements.
Resources for clinical monitoring and site management are located regionally, based on therapeutic experience and on geographical locations of the investigative sites.
TrialMed has a comprehensive training program provides consistent training in Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs)/International Conference on Harmonization (ICH) Guidelines, and regulatory requirements across regions.
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