Conducting clinical trials is inherently complex and engaging with sites is becoming even more competitive, given limited capacity and increasingly overburdened site staff. Recent unprecedented events, notably the global pandemic as well as geopolitical disruptions in Europe, continue to complicate the situation further. In this environment, local knowledge and global experience in site feasibility studies is essential.
Paliser dedicated local teams can provide you with an in-depth understanding of the current dynamics in your area of study and the regions you are considering for your trial. We assess important questions such as:
1. Where is your trial most likely to achieve the expected outcomes within a realistic timeline, given the indication and specific sub-population being targeted?
2. What is the trial phase, mechanism of action relative to both standard of care and other investigational therapies? Determining these factors and their impact on feasibility is the key focus of our work. We work closely with you to identify the optimal strategy for your study. Our global feasibility team, in close collaboration with local clinical operational leads, provides insight into key country-specific clinical considerations to support critical decision-making in your development program. These include, for example, top-level feasibility and site-level feasibility gained from the detailed feedback of clinical research sites. We help determine important parameters such as:
• Relative recruitment potential
• Most favorable countries
• Patient Recruitment
• Project Management
• Clinical Operations
• Monitoring
With collaboration from our medical and operations teams, we review your study design and protocol and can give you guidance feasibility in any stage of the trial. Pre-study feasibility evaluations can be especially beneficial, particularly if you will be conducting a rare disease trial. We’ll develop customized questionnaires to derive the relevant information.
• The global clinical research environment is rapidly evolving, making it essential to explore a digital strategy for data collection for all protocols. We will review the key elements of your protocol, such as endpoint data collection methods, schedule of events, vendor data requirements, patient burden, engagement, and retention. As part of this evaluation, our team will consider options for decentralized or hybrid design elements and make a recommendation in order to help guide you in making decisions that will boost the delivery of your clinical trial.