C-BB3Vclinical biostatistics, study design, integrity analytics
0-100 chain-logic scale · 15 dimensions · scored on public evidence
Extract reliable evidence from clinical trial data and support medical research in Alzheimer's disease and other neurodegenerative diseases.
Clinical trial biostatistics, study design, programming, data management, medical writing, and regulatory support.
Pentara states it provides these services and has co-authored more than 200 publications.
Support study design, analysis, clinical programming, data management, medical writing, and regulatory work for clinical trials, with emphasis on Alzheimer's disease and other neurodegenerative diseases.
Biostatistics, statistical consulting, historical data, simulations, literature reviews, clinical programming, data management, and regulatory support.
Pentara lists active service lines and states its team has co-authored over 200 publications.
Improve statistical analysis and interpretation of Alzheimer's and progressive disease clinical trials.
Research on robust regression versus MMRM and Hodges-Lehman estimators, interim analysis strategy, and time-scale target parameters with two-step estimation.
2026 Statistics in Medicine publication applied time-scale target parameters in a Phase 2/3 Alzheimer's trial; 2025 and 2024 publications addressed interim analyses and analytic challenges in early Alzheimer's disease.
The 2024 analytic challenges paper found robust regression had smaller standard errors and more power than MMRM and Hodges-Lehman in simulated early Alzheimer's trial data patterned after recent trials.
Investigate reasons why treatments identified as effective in an Alzheimer's disease meta-analysis failed in clinical studies.
Meta-analysis and failure investigation of Alzheimer's disease studies.
2025 publication listed on Pentara's publications page.
Investigate reasons why treatments identified as effective in meta-analysis of Alzheimer's disease studies may fail in later development or trials.
Meta-analysis and failure analysis of Alzheimer's disease treatment studies.
2025 publication listed: "Learning from Failure-Investigating Reasons for Failure of Effective Treatments Identified in a Meta-analysis of Alzheimer's Disease Studies."
Evaluate when and why interim analyses should be avoided in Alzheimer's disease and related clinical trials.
Statistical methods research on interim analysis design and decision-making.
2025 publication listed: "Rethinking Interim Analyses: When and Why to Avoid Them."
Investigate reasons why treatments identified as effective in Alzheimer's disease meta-analysis may have failed in later development or trials.
Meta-analysis and failure-mode investigation of Alzheimer's disease studies.
2025 publication listed by Pentara on learning from failure in Alzheimer's disease studies.
Analyze whether biomarker-based Alzheimer's trial inclusion criteria may create differential access across racial and ethnic groups.
Analysis of the Bio-Hermes study focused on biomarker-based inclusion criteria.
2025 publication listed on Pentara's publications page.
Assess whether biomarker-based Alzheimer's trial inclusion criteria may differentially affect access across racial and ethnic groups.
Analysis of the Bio-Hermes study focused on biomarker-based inclusion criteria and trial access.
2025 publication listed: "Has Alzheimer's Been Defined as a White Person's Disease?"
Assess whether biomarker-based inclusion criteria may differentially affect access to Alzheimer's clinical trials across racial and ethnic groups.
Analysis of the Bio-Hermes study focused on Alzheimer's biomarker inclusion criteria.
2025 publication listed by Pentara on biomarker-based inclusion criteria and trial access.
Detect fraud or data integrity problems in clinical trials using anomaly detection and monitoring.
Data anomaly detection and monitoring tools applied to clinical trial datasets.
Pentara's site analysis describes fraud detection using data anomaly detection and monitoring tools.
Detect potential fraud or data integrity issues in clinical trial datasets.
Fraud detection as part of Pentara's clinical trial support offering.
Listed among Pentara's clinical trial support capabilities.
Improve statistical analysis of early Alzheimer's disease trials affected by skewed outcomes and imbalance in rapid progressors.
Simulation comparing mixed-effects models for repeated measures, robust regression, and Hodges-Lehman estimation.
2024 medRxiv publication.
Robust regression yielded smaller standard errors and more power than MMRM and Hodges-Lehman in simulated datasets patterned after Alzheimer's trials, while maintaining Type I error control.
Assess hippocampal atrophy on MRI as a surrogate marker for clinical benefit and neurodegeneration in early symptomatic Alzheimer's disease.
Synthesis of evidence from observational and interventional trials.
2025 publication listed on Pentara's publications page.
Evaluate hippocampal atrophy on MRI as a surrogate marker for clinical benefit and neurodegeneration in early symptomatic Alzheimer's disease.
Synthesis of evidence from observational and interventional Alzheimer's disease trials.
2025 publication listed by Pentara on hippocampal atrophy as a surrogate marker.
Support use of plasma pTau as a predictive early endpoint in Alzheimer's trials, including ProMIS Neurosciences' PMN310 Phase 1b PRECISE-AD trial.
Peer-reviewed publication and clinical data analysis services supporting ProMIS Neurosciences.
BioSpace record states Pentara provided clinical data analysis services to ProMIS for a publication supporting the PMN310 Phase 1b PRECISE-AD trial.
Evaluate RNS60 as an adjunct therapy for acute ischemic stroke patients undergoing endovascular thrombectomy.
Post hoc analysis of a randomized, blinded, placebo-controlled, parallel-group RESCUE trial in participants enrolled less than 12 hours since last known well.
Filtered publication record for RNS60 RESCUE post hoc analysis.
Assess analytic approaches for skewed data and rapid progressor imbalance in early Alzheimer's disease clinical trials.
Simulation studies comparing mixed-effects model for repeated measures, robust regression, and Hodges-Lehman estimator.
2024 medRxiv publication: "Analytic Challenges in Clinical Trials of Early Alzheimer’s Disease."
In simulated data patterned after Alzheimer's trials, robust regression produced smaller standard errors and greater power than MMRM and Hodges-Lehman, and was less affected by imbalance in rapid progressors.
Incorporate patient perspectives into a composite score for measuring disease progression in spinocerebellar ataxia.
Reweighting SCACOMS items using partial least squares-derived weights and patient feedback from semi-structured interviews.
2026 Neurology and Therapy publication.
Patient-informed weighting increased patient centricity but reduced sensitivity to detect change versus the PLS-derived SCACOMS.
Assess simufilam in mild-to-moderate Alzheimer's disease using Phase 3 randomized clinical trials.
RETHINK randomized simufilam 100 mg versus placebo for 52 weeks; REFOCUS evaluated simufilam 50 mg and 100 mg versus placebo for 76 weeks with clinical, plasma biomarker, CSF, and imaging endpoints.
2026 publication reported results from the Phase 3 RETHINK and REFOCUS trials.
Both trials failed to meet co-primary, secondary, or exploratory biomarker endpoints. REFOCUS was terminated early. Simufilam was reported safe and well tolerated.
Evaluate simufilam in mild-to-moderate Alzheimer's disease.
Phase 3 randomized clinical trials.
2026 publication listed: "Phase 3 randomized clinical trials of simufilam in mild-to-moderate Alzheimer's disease."
Analyze Phase 3 randomized clinical trials of simufilam in mild-to-moderate Alzheimer's disease.
Randomized Phase 3 clinical trial analysis in mild-to-moderate Alzheimer's disease.
2026 publication listed: "Phase 3 randomized clinical trials of simufilam in mild-to-moderate Alzheimer's disease."
Improve measurement of disease progression in spinocerebellar ataxia by incorporating patient perspectives into a composite clinical score.
Reweighting SCACOMS items using patient feedback and partial least squares-derived item weights, then comparing responsiveness using 1-year mean-to-standard-deviation ratios.
Publication reported patient-informed SCACOMS weighting analysis.
The PLS-derived SCACOMS had the highest responsiveness; patient-informed weighting increased patient centricity while reducing responsiveness compared with the statistically optimized version.
Incorporate patient perspectives into a composite score for measuring disease progression in spinocerebellar ataxia.
Reweighting SCACOMS items using patient feedback and partial least squares-derived item weights; comparing one-year mean-to-standard-deviation ratios.
2026 Neurology and Therapy publication on incorporating patient perspectives into SCACOMS.
PLS-derived SCACOMS had the highest responsiveness; patient-weighted versions increased patient centricity but reduced sensitivity to detect change.
Define minimum and preferred characteristics for therapies intended to delay or prevent symptomatic Alzheimer's disease.
International expert stakeholder process convened by the Global CEO Initiative on Alzheimer's Disease to develop target product profiles.
2026 Nature Medicine publication indexed in PubMed.
The target product profiles outline intended use, target populations, safety expectations, and efficacy benchmarks for preventative Alzheimer's therapies.
Define minimum and preferred characteristics for therapies intended to delay or prevent symptomatic Alzheimer's disease.
International expert group development of target product profiles covering intended use, target populations, safety expectations, and efficacy benchmarks.
2026 Nature Medicine publication on target product profiles for treatments to delay or prevent symptomatic Alzheimer's disease.
The target product profiles provide a framework to guide therapeutic development, regulatory evaluation, and patient-centered assessment of emerging preventive Alzheimer's therapies.