First-in-Human (FIH) and Early-Phase Trials
One of the critical milestones in drug development is the transition from preclinical to clinical development. At the Accelsiors Phase I unit, our underpinned expertise is in executing first-in-human (FIH) and early-phase trials without compromising on safety, precision, and efficiency of your trial. The Accelsiors approach bridges tried and tested methodologies, rigorous compliance, and an unwavering commitment to participant safety. This ensures your clinical trial reaches its objectives, meanwhile ensuring you are set for success in later phases.
First-in-Human (FIH) and Early-Phase Trials Services
Safety and compliance are the cornerstones of FIH and early-phase trials. Highly trained Accelsiors clinical teams conduct continuous monitoring and advanced safety assessments to identify potential risks early, ensuring participant well-being and high-quality data integrity. We adhere to local and international regulatory standards, with regulatory experts supporting protocol submissions, ethics board approvals, and ongoing compliance throughout the study.
The Accelsiors expertise in pharmacokinetics (PK) and pharmacodynamics (PD) ensures comprehensive insights into your drug’s behaviour in the human body. This data supports dose optimisation and informs critical decition making. At Accelsiors we also design and execute single ascending dose (SAD) and multiple ascending dose (MAD) studies with exceptional attention to detail. This attention to detail ensures safe dose escalation and valuable therapeutic index data. Additionally, we integrate biomarker analysis into early-phase trials, offering actionable insights into drug efficacy, mechanisms of action, and safety signals to refine development strategies.
Accelsiors innovative trial designs include adaptive approaches, such as cohort expansions, integrated PK/PD modelling, and umbrella or basket studies. These methods optimize resource utilization and increase the likelihood of meaningful outcomes. We also utilize real-time data collection and monitoring tools to provide immediate insights into trial performance, enabling proactive adjustments and ensuring studies stay on track and within budget.
Utilising our strategic location within a public tertiary clinic to ensure rapid access to healthy volunteers and specialised patient populations. Our emphasis on participant comfort, engagement, and flexible scheduling enhances retention rates, minimising trial disruptions. By prioritising participant needs, we improve data reliability and create a positive trial experience for all involved.
At the conclusion of your trial, Accelsiors delivers detailed, regulatory-compliant reports that include key safety, efficacy, and PK/PD findings. These detail heavy reports are designed to support seamless transitions to Phase II studies and regulatory submissions, ensuring your drug development journey continues smoothly.
