Clinical Monitoring

Align CRO understands that effective clinical monitoring is essential to the accuracy of a study’s data. Effective monitoring is also vital to ensuring protocol compliance and monitoring the ongoing safety of the patients participating in a clinical trial.

Align CRO contracts a clinical trial monitoring team that performs on-site monitoring activities.  Additionally, Align CRO takes a risk based approach through central study monitoring activities based on key risks and thresholds.  Details of the full scope of study monitoring is laid out in the agreed upon Study Management Plan

On-site clinical monitoring activities with Align CRO include, but are not limited to:

• Source to Data (CRFs or eCRFs) verification for accuracy and completeness

• Regulatory retention and consent review

• Drug accountability review

• Continuing study education

Central monitoring activities with Align CRO include, but are not limited to:

• Data analysis to identify trends related to protocol compliance, patient safety, enrollment rate, and other parameters

• Review of performance metrics at the site level and the study level

• Institute corrective actions plans to manage / mitigate identified risks / issue(s)

A summary report of all monitor activities is prepared in a concise format and forwarded to the Sponsor following each on site visit and at regular intervals during the study for central monitoring activities. This process helps ensure that the Sponsor is kept abreast of all study data and activity at the sites, as documented through clinical monitoring.