Bola Oyegunwa is the Vice President and Global head of Hybrid/Virtual Trials at Covance. Bola has significant experience in the CRO industry developing innovative clinical trial solutions to streamline study execution. Bolaís previous experience includes Virtual Trial Implementation at IQVIA and Head of Strategy & Chief of Staff to CEO at Cenduit.
Digital Trials of the Future: Quality by Design Best Practices
Patient-centric virtual trial delivery modalities are increasingly becoming an alternative to site-based models. Ensuring quality delivery during the implementation of virtual trial models requires comprehensive assessment of protocol suitability, operational and regulatory risks. Many factors including therapeutic area/indication, patient population, disease burden, safety profile of the investigational compound, primary and secondary endpoints should be assessed to determine protocol suitability prior to implementation of a virtual delivery model. In addition, risk analysis should be performed to proactively detect and prevent quality issues from occurring. Development of effective risk mitigation strategies are essential to safeguarding data quality, patient safety, regulatory compliance and study oversight. Insights generated from protocol suitability and risk assessments should inform protocol optimisation and selection of an optimal delivery modality (hybrid virtual or pure virtual). Automated alerts and notifications, protocol compliance monitoring and centralised patient surveillance plans are important to achieving operational excellence. Covance offers best practices for determining protocol suitability for hybrid virtual trial models, selecting and implementing an optimal delivery strategy, conducting a risk assessment and developing an execution approach that will ensure quality delivery.