Pentara offers tables, listings, and figures with a focus on automation, compliance, and quality to meet regulatory standards. We offer specialized and novel analyses for clients across all phases of research. Pentara's TFL templates have been accepted in regulatory submissions of NDAs. We specialize in optimizing the analysis of efficacy outcomes based on historical datasets, simulations, and literature reviews. We have expertise in MMRM, Cox proportional hazards, nonparametric analyses, and multivariate analyses.
Pentara has developed and championed novel approaches to modeling efficacy outcomes in tables, listings, and figures. We are leaders in the field and have presented their work at various clinical and statistical meetings. We specialize in global statistical tests (GSTs) for clinical trials with multiple outcomes, patient level GSTs, combining outcomes using summary statistics, and parametric and non-parametric GSTs. Pentara also uses a time component test (TCT) to assess disease modification and composite scores such as ADCOMS and APCC. These approaches are aimed at improving the assessment of disease-modifying therapies and knowing whether secondary endpoints are supportive, confirmatory or contradictory of the primary endpoint results.
Pentara provides comprehensive support for planning, executing, and approving clinical trials and exploratory research. This includes support for DSMB and interim analyses. For DSMB, Pentara can produce blinded and unblinded safety TFLs based on the DMC Charter and the SAP, and can prepare the full DSMB presentation if requested. Pentara statisticians can attend the DSMB meeting, with a blinded statistician attending the open session and an unblinded statistician attending the open and closed sessions. Pentara also can provide an independent statistical committee member for DSMB participation. For interim analysis, Pentara can run unblinded efficacy output based on the interim analysis described in the SAP.