Applying for a clinical trial grant can sometimes feel like turning in a high school English paper. You could turn in the same exact paper on a different day of the month and get very different grades based on factors that seem out of your control (like whether the teacher is having a good day). However, some critical ingredients can help an application stand out to Federal regulators (e.g., FDA and NIH). Organizations who select eClinical technology partners prior to submitting their application can strengthen their case by detailing data flows, risk mitigation measures, and proven best practices. Demonstrating familiarity and competence with identified technology partners shows that the applicant has the knowledge and experience needed for success in their efforts.
What are some best practices regulators look for?
Excite Your Audience – Present the research in a way that will drive curiosity and interest from peer reviewers. The bigger the research’s impact, the more exciting the project will be. Look to quantify in large terms the level of impact the investigative product will have on the broadest number of recipients. Like a tech startup seeking venture funding, tell your audience how you are going to change the world.
Study Planning – Demonstrate your preparedness by talking about the study build, site onboarding, and enrollment strategies. What is your plan and how will this process be monitored? What are the risks and how will those be mitigated? Have you identified any tools that will help you measure and track your progress? Lay out your plan in detail and include discrete sequential steps.
eClinical Technology Partner – Once your audience is excited about the project and understands your preparedness, they will need to be convinced that the right team is in place for successful project execution. Who will you be collaborating with and how are they specifically qualified for this trial? An eClinical technology partner will provide more than the software that houses the clinical data. They are someone who knows how to leverage technology to minimize execution risk throughout the trial, from designing CRFs and facilitating site training to maximizing data quality and removing human error almost entirely.
Prelude Dynamics has been an eClinical technology partner for many Federal grant recipients. We routinely provide language for applicants to include in their applications and have also provided letters of support for clients. In our experience, early collaboration with researchers adds detail, depth, and substance to Federal clinical applications – streamlining the award/approval process.
We are your eClinical Technology Partner! Reach out and let us help you plan your next study!