CASE STUDY

Global Healthcare Conglomerate Improves Quality Adherence in Clinical Trials Using Pharmacovigilance Analytics

Sep 23, 2016

Business Challenge

Improving process safety during clinical trials for new cardiology drug

A global conglomerate in the healthcare industry, with ongoing clinical trials in 15+ countries, wanted to ensure process safety and real-time monitoring of the trials.

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Situation

Real time monitoring of new drug clinical trial to ensure process safety

The healthcare industry client wanted real time monitoring of clinical trials for its new cardiology drug, in order to maintain clinical safety, closely monitor the use of the product in clinical practice, and predict and prevent potential serious safety risks

Solution/Approach

Pharmacovigilance analytics and CRF generation for hybrid reporting

We used process analytics, monitoring of summary of product characteristics (SmPC) compliance, benefit risk analysis, and adverse events reporting for understanding of protocols adherence and regulatory compliance in all data collection and reporting; along with case report forms (CRFs) generation for use in both EDC and paper based, (i.e. hybrid) reporting.

Impact

Improved trial accountability, prevention of serious safety risks

Through the insights from pharmacovigilance analytics, the client improved the accountability for drug development clinical trials, ensured regulatory compliance through documentation, and was able to conclude the study meeting all the safety objectives.

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