Our services
Trial Design and Endpoint Strategy
Design and endpoint decisions determine whether a trial can support the claim you want. Verida advises on trial design, including adaptive approaches, and on estimand framing under ICH E9(R1) to clarify how intercurrent events such as treatment discontinuation, dropout, or rescue medication use will be handled. We support sample size and power calculations, and the selection or development of novel, patient-centered endpoints that regulators and clinicians find credible.
FDA Regulatory Strategy
How you present results to FDA shapes whether the agency reaches the conclusion you're aiming for. Verida develops the regulatory strategy that carries a consistent, defensible narrative through every touchpoint, from briefing packages and meeting materials to the statistical and clinical sections of INDs, NDAs, BLAs, and PMAs. We represent sponsors directly in meetings with FDA, supporting the scientific story and the sponsor's position in response to reviewers' questions.
Statistical Analysis
We help identify the right study design, including adaptive designs when appropriate, and use simulation to stress-test how that design will perform before a single patient is enrolled. From there we develop the statistical analysis plan, execute the analyses, and interpret the results in a way that holds up to regulatory and scientific scrutiny. We bring particular depth in missing data methods and intercurrent event handling, to ensure that conclusions about the treatment effect are are robust.
Data Monitoring & Independent Review
Ongoing trials need independent oversight independent to protect patient safety and preserve trial integrity. Verida provides unblinded statistical support for data monitoring committees (DMCs) and data and safety monitoring boards (DSMBs), including interim efficacy and safety analyses that inform recommendations to continue, modify, or stop a trial. We also conduct independent statistical review of trial protocols and designs, work that has spanned more than 50 international clinical trials for the Gates Foundation, assessing whether trials are designed to yield informative answers to their scientific questions.