Biostatistics is at the core of every clinical study, from design and protocol development to analysis and reporting. Our highly skilled team of biostatisticians provides biostatistical consulting and services for preclinical and early phase studies to regulatory submissions and postmarketing activities for drugs, biologics, and devices. We are experienced in handling innovative designs, including adaptive methods, Bayesian techniques, basket trials, simulations, seamless trials, umbrella trials, and RWE. Our experienced consultants are available for agency meeting representation.
Statistical programmers at Veranex work closely with our statisticians to ensure analysis and reporting is accurate and adheres to study specifications and plans. Programmers have extensive CDISC experience with a range of therapeutic experience, including oncology, CNS, and cardiovascular indications. We select and/or recruit the right-sized statistical programming team (from our staff of 250+ programmers) to meet study needs and to deliver study deliverables on time. Whether study needs are small or large, urgent or still in the planning phases, Veranex can provide an experienced team to do the job on a cost-effective basis.
We ensure 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.
Statistical and Programming Services:
- Provide study design expertise for protocol development
- Protocol development and review, including statistical sections, sample size and power calculations, and randomization methodology
- Randomization plan development review and implementation, with IVRS and IWRS support
- Blinded/unblinded data review and analysis support
- Statistical and programming support for data monitoring committees (DMC, DSMB)
- Statistical analysis plan (SAP) and mock shell development
- PK/PD analyses and modeling
- Analysis of cardiac safety data (pilot and thorough QTc studies)
- 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
- BIMO listings and other regulatory reports