Monitoring
Our comprehensive monitoring services encompass protocol quality control, site screening, study set-up, user acceptance testing, real-time oversight, and study close-out, ensuring adherence to VICH GCP standards and seamless conduct of veterinary clinical studies.
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Monitoring
Monitors of a veterinary clinical study adhering to VICH GCP play a critical role in ensuring the integrity, quality, and ethical conduct of the study. Having a good monitor on a clinical study is crucial to the success of the study.
Our services include: Provision of a Lead Monitor, Protocol Quality Control, Site Screening & Investigator/Third Party Qualification, Study Set-Up, User Acceptance Testing, Study In-Phase Oversight, Study Close-Out.
Example of Monitoring
Ensuring Precision and Compliance
Whilst some clients prefer The VICH GCP Consultancy to operate according to the Sponsor’s own Standard Operating Procedures, a Study Monitoring Plan is typically developed for projects. This is a document which states the monitoring responsibilities for the study as well as the critical data verification and validation points for monitor checking during the study period. Each monitoring plan is tailored specifically to the project. So, for example, if the Sponsor wanted a more “risk-based monitoring” approach this would be fully described in the monitoring plan and would detail the percentage check for each data set.
Click below to download the example monitoring plan and explanatory notes, including the data verification checks for an example study.
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