All our clinical research personnel are highly experienced and fully conversant with FDA and ICH guidelines for Good Clinical Practices. Our CRAs adhere to following the SOPs provided for each study. Monitoring visits are scheduled routinely six to eight weeks but will be more frequent when the complexity of the trial demands. 100% source document verification is performed at these visits. The CRA will prepare a report to document the activities performed at each visit. These reports are reviewed by the Project Manager and are available for review by the Sponsor.
Our CRAs continue to receive regular training to ensure that they are aware of the latest developments within the healthcare industry. CRAs receive project related training, including therapeutic area and disease-specific tutorials, at the start of each study.
