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.