"We'll deal with the odd values when we unblind."
"The biomarker moved. The clinical endpoint hasn't, yet."
Our TLF templates have been accepted in NDA submissions. We generate the outputs regulators expect, in the format they expect, removing one of the most common sources of deficiency letters.
We deliver regulatory-compliant tables, listings, and figures through automated, quality-focused processes, and provide specialized statistical analyses across all research phases, optimizing efficacy outcomes using advanced methods like MMRM and Cox proportional hazards.
Pentara leads in novel efficacy outcome modeling, showcased at clinical and statistical meetings. We specialize in Global Statistical Tests (GSTs) for multi-outcome trials, including patient-level and combined outcome analyses, and employ Time Component Tests (TCTs) and composite scores to sharpen disease-modifying therapy assessment.
Comprehensive clinical trial support from planning to approval, including DSMB and interim analyses. For DSMBs we generate blinded and unblinded TLFs, prepare presentations, and provide blinded or unblinded statisticians, or independent committee members. For interim analyses we produce unblinded efficacy output.
Pentara recognizes the benefits of having high standards for our industry. Pentara requires all programmers to be SAS certified; even our summer interns must be SAS certified before they can work here.
Those standards are why our TLF templates have been accepted in NDAs, and why our output moves through review without rework.
100%
SAS-certified programmers
NDA
Accepted TLF templates
All
Research phases supported
200+
Publications
ADCOMS
Detecting decline in prodromal and mild Alzheimer's disease, where single scales barely move over 18 months.
Publication → (opens in a new tab)iADRS
One score for cognition and function, so an effect on both does not split into two underpowered tests.
Publication → (opens in a new tab)APCC
Tracking cognitive change in people who do not yet have symptoms, for prevention trials.
Publication → (opens in a new tab)GST
Testing a treatment across many endpoints at once when no single endpoint can be powered on its own.
Publication → (opens in a new tab)TCT
Expressing an effect as time saved, so "slowed decline" means something to a patient and to a reviewer.
Publication → (opens in a new tab)The category
Measuring change in slow, heterogeneous, hard-to-measure disease. That's the problem these exist to solve, and it's the only thing we've done for twenty-five years.
Browse the publicationsLeast expensive point to bring us in · Blinded accumulation
Influence and tipping-point testing while the data is still blinded. Later, you find the problem the day after unblinding.
From DSMB support to novel efficacy modeling, we'll scope the work with you.
