Clinical Monitoring is an integral part of the quality control of a clinical trial which verifies at a site level the ongoing data integrity and trial conduct to enhance subject protection. Frontier Science has trained monitoring staff with demonstrated site monitoring and/or auditing proficiency, several with complementary data management experience. We conduct monitoring activities in accordance with GCP and reflect current industry risk based guidelines. Monitors carefully prepare, and adhere to FSS procedures to ensure high quality review of data.

Frontier Science can provide the following monitoring services:

  • on-site monitoring independent of the sponsor including the accuracy of the CRF data with source documents, informed consent reviews, data collection checks, resolving data queries; adherence to the protocol and safety reporting.
  • development of a trial-specific monitoring plan

FSS monitors have expertise in regulatory/site file review providing guidance on site file contents also procedures for maintenance and retention to meet sponsor, local legislation and GCP.

FSS monitors provide an effective interaction between the sponsor and sites. FSS monitors develop meaningful monitoring visit reports and collaborate with sites to coordinate and progress timely follow up of actions.