Clinical Trial Study Design
We partner with our clients to create robust, customized study protocols that align with their therapeutic objectives and strategic goals. Our integrated approach combines scientific rigor, operational feasibility, and regulatory expertise to lay the foundation for successful execution and actionable results.
Our Approach to Study Design and Protocol Development
Accelsiors clinical trial study design services are unique in delivering tailored, patient-centric, and incredibly adaptive clinical trials which are in line with regulatory and industry standards. The Accelsiors guarantee of excellence is brought to our clients by data-driven methodologies, including Quality by Design (QbD), real-world data integration, and biomarker analysis. These steps ensure meaningful and measurable study outcomes. As such, precise sample size calculations, extensive feasibility assessments, as well as strategic site selection are all means of achieving statistical and operational excellence.
Compliance and Integration of Innovative Methodologies
Compliance, efficiency, and overall smooth progress through your clinical trials are ensured by our expertise in regulatory affairs and risk-based monitoring. Ultimately, we encourage and utilize innovative digital health technologies and sustainability practices, showcasing our modern practices, by which we ensure the best outcomes for your clinical trial. This guarantees a coherent and pleasurable experience to all stakeholders throughout the study.
Key Features of Study Design Services
Accelsiors are here to help develop customised study protocols, specifically tailored to each study based on the therapeutic area and study objectives. Compliance with both industry standards and regulatory guidelines is ensured by our experienced staff. Furthermore, the experience Accelsiors holds ensures an adaptive approach to your study design, which allows for protocol modifications based on interim results, to optimise timeliness and use of resources, all meanwhile ensuring and maintaining a scientific-first approach. Patient centricity is at the very core of our focus, which helps with participant retention, as well as overall engagement to better recruitment rates and minimise drop out risks.
Integrating Quality by Design (QbD) principles helps proactively identify and mitigate risks, thus improving study efficiency and guaranteeing reliable outcomes. At Accelsiors we do comprehensive feasibility checks to evaluate recruitment challenges, logistical and operational aspects, opening up to strategic adjustments early on, to guarantee easy adaptability. Based on our experience, to strategically approach a study means to ensure meaningful and measurable outcomes that will deal with scientific and regulatory requirements very swiftly. All this, while real-world data integration brings forward the most outcome aligned clinical practices and market needs to the trial study designs.
Accelsiors has rigorous statistical techniques which ensure the highest quality of work we produce for your clinical trials. A precise sample size estimation, balancing statistical power, operational feasibility, and cost-efficiency. Keeping all these factors in mind, at Accelsiors we would like to underline how a our approach to a Statistical Analysis Plan (SAP) ensures robust analysis aligned with trial objectives. Additionally, we integrate advanced biomarkers and imaging endpoints where applicable, enabling deeper insights and more precise decision-making.
The Accelsiors Regulatory Affairs unit ensures proactive interactions with authorities, on top of detailed knowledge of global regulatory requirements. Specifically, the early engagement of our regulatory experts ensures more than just being proactive, it also ensures we are in constant connection with the authorities, reducing the risk of any delays and ensuring all study protocols meet the necessary regulatory requirements. Risk-based monitoring (RBM) ensures our focus is on prioritising critical data and processes, which then helps Accelsiors improve study efficiency, all whilst building the study on our pillars of highest quality standards and compliance. Our Accelsiors pillars ensure compliance with global regulators, and exceed the required limits.
For multicentre trials, we assist in selecting high-performing global sites to ensure optimal recruitment and regulatory adherence. We implement innovative data collection strategies, leveraging digital health technologies, wearable devices, and remote monitoring to enhance data accuracy, reduce site burden, and improve participant convenience. Additionally, we incorporate sustainability and environmental considerations into study designs where possible, aligning with ESG (Environmental, Social, and Governance) principles to minimize the environmental impact of clinical research.
