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The biggest risk to any exercise as complex as a clinical research study is that an unidentified risk will crop up somewhere along the way to prevent a successful outcome. 

A clinical trial is a cornucopia of different stakeholders, agendas, modus operandi and perspectives.  However, mitigating risks can’t be done without identifying them first.  This is what makes managing risk so tricky.  Identifying problem areas before they’ve occurred and envisaging adequate mitigation measures is an imperfect science that only gets easier with experience. 

For this reason, endorsement from regulatory bodies like the USFDA and the EMA, of the concept of Risk-based Monitoring (RBM), and their encouragement to industry to implement it have not been adequate to ensure the successful integration of a risk-based approach into the management of clinical trials.   

At PPCE, our risk experts have over twenty years identifying and mitigating risks in critical industry sectors including healthcare and clinical research. 


Basing the design of a clinical study on the Plan-Do-Check- Act (PDCA) Cycle of Continual Improvement guarantees well-controlled trials with proactive  reporting, decision making and communication and ensures there are no rude surprises along the way.  


  • Identification of KRAs within the Risk Assessment Plan (RAP) 

  • Preparation & Maintenance of the RAP

  • Allocation of a dedicated Risk Monitor

  • Stakeholder Coordination & Communication 

  • Trend Analysis for Key Risk Areas (KRAs)

  • Reporting on Site Progress & Study Health

  • Ongoing Calibration of Site Monitors & Staff

  • Integration of Safety Monitoring Committee and Medical Monitor Inputs 


  • Risk Expertise: Over two decades in the area of Quality and Risk Management gives PPCE the largest pool of dedicated Risk Experts in the Clinical Trial industry.   Designing of the Risk Assessment Plan and its subsequent monitoring is done by healthcare personnel trained in the execution of Risk programs designed to ISO 31000.

  • Risk Monitors:  The Project Risk Monitor is a resource dedicated to the coordination of project stakeholders, monitoring of trends and risk mitigation measures.

  • On Track Studies: Trend Analyses and the proactive reporting of suspect data and  other potential problem areas allow decisions to be made real-time for more successful trial outcomes.   

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