Strategic PROGRAM DEVELOPMENT
For over 20 years, PROMETRIKA’s core team of leaders have collaborated to provide our sponsors with innovative, nimble strategies for successful clinical development. Today’s biopharmaceutical research environment requires the expertise of seasoned professionals who are able to envision specialized solutions to atypical challenges in product development planning. As you prepare to enter the clinic, the PROMETRIKA team, led by our regulatory strategists in collaboration with our highly experienced clinical and statistical experts, can assist you with a fit-for-purpose clinical development plan.
Our team has experience with drugs, biologics and devices across a wide range of therapeutic areas in the US and the EU. We can assist you in generating development programs that simultaneously meet the needs of both regions. Our regulatory affairs team can help you determine if the development program may be accelerated through any of the available regulatory pathways in the US and EU (e.g., Fast-Track Designation, Break Through Therapy Designation, PRIME).
Our statisticians conduct the statistical study design and sample size estimation for each study in the development plan and assist your team in determining appropriate decision points in the development path while incorporating flexibility to adapt the plan based on accumulating knowledge. We work with the sponsor’s team to leverage adaptive trial design techniques to create more streamlined and efficient clinical development plans. Our experts can advise on adaptive dose finding, group sequential designs, sample size re-estimation, adaptive enrichment, and adaptive randomization designs.