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Clinical Trial Monitoring

Our CRAs are highly skilled and well-trained to conduct timely execution of clinical trials. Our CRAs are from Medical and Life Sciences background that adds more value to Clinical Operations Department. They have strong communication and organizational skills and maintain good rapport with the investigational sites. Our CRAs are well trained in ICH-GCP, Schedule Y, USFDA and other national and international guidelines.

Our CRA professionals have effectively monitored studies across all phases of product development and ensure ICH/GCP compliance and data integrity at each site visit -- consistently collecting high-quality clinical data on-time.

Our CRAs regularly telephonically follow-up with the investigational sites to update the weekly status is common. Our team has good knowledge in handling the software tools like Electronic Data Capture (EDC), Interactive Voice Response System (IVRS) and Interactive web Response System (IWRS). Our CRA’s conduct onsite monitoring visit throughout the study to ensure:

 

Enrollment status.

Essential document tracking.

Site SAE status (if any).

Review Investigator Site File.

IP accountability.

Review source data and CRFs.

Resolve data queries.

Ensure regulatory compliance.

 

 

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