Clinical Development Consultancy

When we partner with Sponsors, we do so to create tailored clinical development plans, which align with therapeutic goals, market demands, and regulatory requirements. That is why we prioritise therapeutic indications by evaluating market potential, clinical feasibility, as well as patient needs. Following all these steps ensures our work is targeted and effective. Regulatory planning is integral to this process, as we provide expert guidance on submission strategies, different pathways, and early engagement with the authorities (FDA, EMA, and other local regulatory authorities) to expedite the approval process by complete regulatory and ethical readiness. Furthermore, we ensure a cost-effective way of optimising trial designs, we streamline workflows and ensure cost avoidance where possible. All this allows Sponsors to maximise their development budgets, whilst we take care of the high quality.  

The expertise we have at Accelsiors ensures that every aspect of clinical trial planning and execution is optimised for efficiency and accuracy. When it comes to early-phase trials, we make sure to employ adaptive methodologies and innovative endpoints, resulting in seamless transitions between trial phases to accelerate timeliness and reduce cost where possible, without compromising on quality. Our streamlined approach to phase transitions ensures continuity, including planning for expanded patient populations, multi/site trials, and a smooth transition to a Phase IIa study, or an integration into a Phase IIb or III study. The inclusion of PK, PD, and biomarker development into trial designs provides valuable insights into therapeutic windows, drug efficacy, and safety to guide data driven decision making and maximise trial success.  

Clinical trial programs remain on track and within budget with our comprehensive feasibility assessment and proactive risk management strategies. We can identify potential risks and develop strategies to mitigate them, by evaluating operational, logistical, and scientific challenges early on. To make sure we understand the market, our competitive landscape analysis offers detailed insights into similar therapies, ongoing trials and market trends. This detailed approach allows both us at Accelsiors and Sponsors to refine positioning and enhance the value proposition of therapeutic candidates. We also facilitate collaboration with key stakeholders, investigators, patient organisations, as well as regulatory authorities, to make sure we create an environment for a collaborative, supportive approach and a well-rounded clinical development ecosystem.  

Accelsiors delivers detailed insights and utilises extensive therapeutic knowledge and expertise to ensure informed decision-making throughout the clinical development process. Comprehensive reviews of trial data, critical analysis to support you in your decision making, and refining development strategies as needed are just a few of our watermarks of the devoted and dedicated, high quality, scientifically driven work we do. With decades of studies and a varied therapeutic experience, including oncology, immunology, neurology, and rare diseases, our experts offer the most innovative, unique and thought defining recommendations to your study. The Accelsiors approach of combining data-driven insights and specialised knowledge by our leading experts ensures that every aspect of your clinical programme is aligned with key milestones and scientific advancements.