We can build innovative optimal study designs in collaboration with regulatory and clinical teams to best suits the scientific and medical environment and ensure regulatory or post-submission requirements are met. In particular, our team has a breadth of experience in adaptive and sequential designs and can run simulations to evaluate and optimize design options.
Learn more about Complex Innovative Trial Designs (CIDs) Our expert consultants can act as voting members and independent statisticians in a number of external study committees like DMCs or DSMBs. They bring their statistical expertise in supporting DMCs/DSMBs with implementation and review of data analyses to assist with recommendations and decision-making process while ensuring integrity of the trial. We can offer a comprehensive package to support planning and logistics of blinded and unblinded teams that fits your needs.
Our experience in interacting with regulators, including FDA and EMA, across all types of meetings allows us to provide strategic insights in your interactions. We can support you in preparing briefing documents, by attending meetings to represent statistics or in defending statistical methodologies and answering questions related to statistics.
We can support your team in implementing and interpreting complex statistical methodologies by writing sections of protocols or analysis plans or help with the programming and review of analyses.
We can bring statistical expertise in the review of a product under consideration before a transaction. We provide an independent evaluation focusing on assessing the robustness of the data and probability of success and giving insights into clinical development plan and future needs considering interaction with authorities and impact on time to market.
