Quality Assurance

Data accuracy, compliance to ICH-GCP, local and international regulations and strict adherence to procedures at every level of the study are some of the challenges when managing quality control activities.

Review of study files on-site and in-house

Assistance in maintenance of updated files

Informed Consent Form process and documentation review

Quality assessment of source data

Creation of Standard Operating Procedures (SOPs)

Validation of existent SOPs

In-house and on-site training to enhance quality