PROMETRIKA understands that launching a strong clinical program starts with a foundation of pre-IND strategy and planning. We help our sponsors draft a Clinical Development Plan, a key building block that guides many pre-IND activities and provides a roadmap for multiple scenarios depending on regulatory authority input, natural history study outcomes, and other potential factors. Early communication and meetings with regulatory authorities are important to ensure alignment to their feedback. PROMETRIKA’s regulatory strategists can help with all aspects of meeting preparation, conduct and follow-up. Our regulatory strategists can also work with our sponsors to develop the IND and ensure its submission readiness. The Medical Writing team is available to draft the clinical protocol, and PROMETRIKA’s Biostatisticians ensure the protocol is fit-for-purpose with appropriate endpoints, estimands, sample size estimation, and overall statistical study design.
Natural history studies during the pre-IND phase, for rare diseases especially, are critical to better understanding the patient population and its experience with the disease and treatment in the real world. The understanding gained from a natural history study can be used to improve the design of planned clinical studies based on what we learn regarding which sub-populations may most likely benefit, selection of primary and secondary endpoints and timing of their related assessments, and what sites and investigators are best able to implement the planned clinical trial. There are many design aspects with natural history studies that PROMETRIKA helps our sponsors to consider, including whether a retrospective or prospective approach would best fit the project given the disease, population and objectives under study.
- Natural History Study Design and Implementation
- Surrogate Endpoint Development
- Global, Region-Specific Regulatory Authority Meeting Planning
- Review of Regulatory Agency Feedback