Clinical Audit And Monitoring

It is of utmost importance to establish auditing processes and quality assurance at the beginning of a clinical study. Quality has to be built in at every step of clinical development process: right from designing of a protocol & case report forms to preparing and submission of reports.

We are known for our:

  • Professional monitoring.

  • ICH – GCP compliant SOPs.

  • High quality data.

  • Detail oriented efficient monitoring.

  • Regular communication and feedback to the sponsor.

  • Experience in all phases ( I thru IV) of development including BA/BE/PK studies.

Our ICH – GCP compliant standard operating procedures include outlines and methods for all visit types including:

  • Pre-investigational site visits (PISV).

  • Site initiation visits (SIV).

  • Site monitoring visits (SMV).

  • Site closure visits (SCV).

Additional specialty services:

  • Development of SOPs and STPs compliant with regulatory and other relevant guidelines through extensive review of literature.

  • Review of existing SOPs to ensure clinical effectiveness.