Study Planning
Laying the groundwork for success
We at Aurora Clinical Research support study planning across a wide range of research designs and statistical methods, from randomized clinical trials and adaptive platform designs to pragmatic and real-world outcome studies.
Whether you’re preparing a grant submission or building a protocol from the ground up, our team tailors its expertise to the scientific and operational needs of your research.
Areas of Focus
Budgeting
We provide expert advice and consultation on budgeting for your clinical trial grants to ensure accuracy and feasibility. Estimating study costs, including but not limited to site fees, study drug/device supply, lab work, and monitoring.
Protocol development
We offer support in development of your study protocol and can help ensure it meets regulatory requirements.
Grant submission coordination
We can contribute specialized knowledge and help you to manage timelines, deadlines, and prepare supporting documents (i.e. appendices, budget and justification).
Risk assessment and mitigation
We can help you identify potential scientific, operational, and regulatory risks early, and implement strategies to mitigate them and ensure trial continuity and safety.
Planning that Drives Results
From grant funding to protocol development and risk management, here are a few examples of how we put our study planning expertise to work
Have a project in mind?
Leadership in the development, management, and support of diverse grant applications including project, operating, team, and meeting grants. We have a strong track record of success. Our efforts have resulted in over $20 million in awarded funding. We also have experience with leading and securing grants for the National Institutes of Health, Research Manitoba, and various national and local foundations.
Specialized support for platform clinical trial development that includes development of a platform protocol, domain-specific appendices, adaptive design elements, and governance structures. We ensure regulatory compliance and operational feasibility for the platform trial to be scalable, consistent, and efficient.
Dedicated risk assessment support across the full spectrum of clinical trial planning, identifying scientific, operational, and regulatory risks early and developing the mitigation strategies needed to keep your trial on track, your participants safe, and your study audit-ready.