Risk-Based Clinical Development

PRA Health Sciences’ risk-based, comprehensive approach to clinical development and clinical study risk management includes centralized monitoring and advanced analytics as an integral component. It aligns ICH E6 (R2) regulatory guidance with a foundation of ensuring subject safety, Good Clinical Practice (GCP) compliance, and data quality.

Patient-friendly Trials

Patients are at the center of all we do. We design our trials to be as patient-friendly as possible for successful recruitment. Our agile approach allows us to be able to collect patient data from the comfort of their home whenever possible, and use technologies including wearables, mobile apps, telemedicine, and more. We ensure patient safety and that the results of clinical studies are of the highest quality and reliability.

Our patient-centric approach to monitoring means that every patient’s critical patient data is monitored centrally with targeted on-site monitoring for a pre-defined subset of patients.

Cleaner, Faster Data

PRA’s approach creates a customized risk assessment and data-driven strategy, tailored to the study’s unique needs. This risk assessment and data-driven strategy allows us to focus the resources review of critical data and key risks to patient safety and data quality.

Understanding that clinical research data can come from different sources, our state of the art technology platform allows us to review patient data from any data source. This allows our project teams to proactively identify potential issues affecting patient safety or data quality faster than traditional monitoring. The robust analytics applied to all critical patient data provides us the opportunity to identify issues sooner and detect potential trends across sites and patients, allowing earlier intervention than traditional monitoring methods.

Our comprehensive methodology includes centralized monitoring supported by a powerful Clinical Data Risk Platform (CDRP). The CDRP ingests and combines data from multiple sources, leveraging advanced analytics to:

  • Identify data or patient safety issues earlier
  • Prevent issue reoccurrence and improve the data quality overall
  • Allow for a targeted, more effective and efficient use of on-site monitoring

PRA’s Clinical Delivery model is built on a foundation of accelerating clinical deliverables while ensuring patient safety, GCP and regulatory compliance, consistency, and data quality.

Contact us to learn more about our risk-based approach to clinical development

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