Guidance Supports Quality Study Design and Outcomes
Clients often call on MRIGlobal when they know what they need but don’t know how to get there. That is why our expertise in designing pre-clinical research studies that meet the goals of our clients is so beneficial. Our Study Directors and researchers partner with our clients to establish research goals, offer guidance on how to approach the research, develop a research study tailored to achieve those goals, and remain accessible throughout the entire process to address any questions.
To design a pre-clinical research study that achieves the goals you are looking for, it is important to ask these six questions of your CRO:
1. Can you help me define the goals of my research study? At MRIGlobal, our many years of expertise and flexibility in research study design enable us to work in partnership with our clients to clearly understand what they’re trying to accomplish and establish goals to meet that need. The goals for one research study likely differ from the next, so it’s important that they’re clearly and uniquely defined.
2. Based on my goals, can you customize the design of my research study? Because we are invested in the client relationship and with their specific goals in mind, we offer guidance on how to best approach the science involved. This cannot always be accomplished using a standard research design. By customizing the research study to suit the client’s goals, we are able to ask more specific questions and attain more specific answers related to the test article. When necessary, we can also integrate multidisciplinary expertise, engaging researchers and even engineers from across our capabilities to ensure a comprehensive solution.
3. What about possible odd issues related to the test article, such as the dosing route? It is critically important that the route of exposure of the test article be considered when designing the research study. This will enable us to perform the research that most closely mimics the intended use of the test article.
4. Are the Study Director and other researchers available should I have questions? MRIGlobal runs small teams that remain consistent throughout the engagement, enabling them to become intimately familiar with our clients’ ever-evolving needs. We provide clients with a single point of contact for the duration of their research project, giving clients ready access to our technical experts. We can even lead the client’s project team, if requested. Too, we provide ongoing support to help navigate FDA approvals through continuous access to our Study Director and other MRIGlobal scientific experts.
5. Can you assist with the development of my IND? The team at MRIGlobal can definitely assist with your IND application. Read more about our expertise in this area at “Developing Investigational New Drug Applications.”
6. When should we start communicating with regulatory? We encourage clear and early communication with regulatory agencies like the FDA, ensuring that the research study design and results will meet their requirements/standards. This can include confirming details to ensure statistical validity or helping to interpret the necessary regulatory guidelines.
It takes an experienced CRO partner to effectively address these questions and ensure a seamless research process. That is why our depth of experience is helpful in not only designing research studies that are accepted by the FDA, but also then performing the research and providing the necessary data to support approval to advance the drug for use in humans and/or testing in human clinical trials.
GETTING STARTED AT MRIGLOBAL
Contact MRIGlobal for further information about our work with chemical and biological threat agents. Through an interdisciplinary approach, we provide scientific and subject matter expertise for development of medical countermeasures research against these threats.
To discuss how we can help your project be successful, contact us today.
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