Quality planning – the essential requirement for risk-based monitoring

The appropriate quality plan will safeguard the rights and health of human participants and simultaneously guarantee data quality and validity. PPH plus will identify the right quality requirements for your trial and plan monitoring accordingly in order to guarantee the success of your endeavor.

Knowing how to react to identified quality issues enhances control over your trial budget and schedule.

Thus, PPH plus prepares the best suited risk-based monitoring strategy, an adjusted combination of on-site and centralized oversight activities. This strategy is described in a clinical monitoring plan tailored to the risk that each specific trial entails.

In order to capture a multidimensional view of the risk-based approach, PPH plus encourages all customers to consult the RBM analysis document by clicking here.

RBM requires early risk identification



PPH plus achieves quality excellence through:

  • The expert analysis of quality requirements (see RACT plus) and risks derived from the clinical trial protocol
  • Consequent plans (see Risk Management Plan) from their first conception, and
  • The subsequent implementation of a sound strategy for ensuring quality throughout the conduct of your trial

This strategy sets the ground for the most efficient advanced and centralized trial oversight tools such as risk-based monitoring (RBM).

RBM allows you to focus onsite monitoring visits on cases in which concrete risks have been detected instead of unnecessary in-person evaluations conducted at sites routinely.