Safety and Tolerability Assessments

The Accelsiors safety assessments prioritise participant well-being through continuous real-time safety monitoring, adverse event (AE) reporting, and proactive risk mitigation strategies. Advanced technologies track vital signs, lab results, and adverse events, ensuring immediate detection and management of potential concerns. During the protocol design phase, At Accelsios, we identify potential risks and implement mitigation strategies before trial initiation, during the protocol design phase, which enhances participant safety and reduces trial interruptions. Our adaptive safety monitoring approaches allow for flexibility in managing complex trials, including those with high-risk populations or innovative therapies. 

One of our biggest strengths is the broad network of local experts we so proudly utilise, including cardiologists, neurologists, hepatologists, nephrologists, and other specialists, to provide expert consultation on trial-specific safety concerns. Cross-functional safety review committees, composed of multidisciplinary teams and regulatory consultants, comprehensively evaluate safety data to ensure unbiased and thorough decision-making. Real-time data sharing and collaboration with sponsors, regulatory bodies, and consulting experts enable seamless communication and compliance with international safety standards.  

At Accelsiors we take special pride in the detail. As such, we conduct comprehensive and rigorous Pre-Screening and Health Assessments. Participants are faced with exminations and questions, including health history reviews, physical exams, and diagnostic testing, ensuring only eligible individuals are enrolled to minimise risks and enhance safety. Post-trial, we provide robust follow-up services to monitor participant health, demonstrating our commitment to long-term safety and participant care. This dedication fosters trust and improves retention across trials. 

For dose escalation studies, our team conducts detailed safety reviews after each cohort, incorporating input from specialized consultants to carefully evaluate dose tolerability and minimize risks for future participants. Adaptive safety approaches are implemented for complex trials involving innovative therapies or high-risk populations, maintaining trial progress while ensuring participant safety. Our processes ensure that all safety data align with regulatory expectations and support high-quality outcomes.