Biostatistics is an essential component of every clinical study, and our team of highly skilled biostatisticians is here to guide you from preclinical and early phase studies to regulatory submissions and postmarketing activities for drugs, biologics, and devices.
Innovation + Adaption
Our team is experienced in handling innovative designs, including adaptive methods, Bayesian techniques, basket trials, simulations, seamless trials, umbrella trials, and RWE, and is available for agency meeting representation. We pride ourselves on providing accurate and timely analysis and reporting, adhering to study specifications and plans.
Our statistical programmers work closely with our statisticians to ensure the highest quality analysis and reporting, with extensive CDISC experience across a range of therapeutic areas, including oncology, CNS, and cardiovascular indications. Our team is scalable to meet the needs of your study, whether small or large, urgent or still in the planning phases.
At Veranex, we ensure that our biometrics operations are compliant and up to date across all applicable regulations, including 21CFR, ICH GCP, U.S./FDA, U.K./NICE SI, EU CTR, and more.
Our statistical and programming services include study design expertise for protocol development, protocol development and review, including statistical sections, sample size and power calculations, and randomization methodology, as well as blinded/unblinded data review and analysis support. We also offer statistical and programming support for data monitoring committees (DMC, DSMB), statistical analysis plan (SAP) and mock shell development, PK/PD analyses and modeling, and analysis of cardiac safety data (pilot and thorough QTc studies).
Additionally, we provide development of data set (SDTMs, ADaMs, ADS) and TLF SAS programming and validation based on a statistical analysis plan (SAP), review and interpretation of tables, listings, and figures for statistical study report and/or as input to a CSR, exploratory analyses for publications, abstracts, and marketing including meta analyses, support with regulatory reporting for DSUR, PSUR, and 120-day safety updates, CDISC conversion of legacy data, and BIMO listings and other regulatory reports.
We provide our clients with the highest quality biostatistical consulting and services to ensure the success of your clinical study.