Software Development Plan

Online and Local Apps for Dose Escalation Designs.

Upcoming: Perform A+B, Rolling-Six, CCD, TPI, mTPI, mTPI2 / Keyboard, BOIN, TEQR, I3+3 and WW designs.

Online and Local Apps for Proof of Concept Designs.

Upcoming: Perform Simons' Two Stage and Bayesian Continuous Monitor designs.

Online and Local Apps for Group Sequential Designs.

Upcoming: Perform 1) equally spaced upper boundary including Pocock, Haybittle-Peto, O'Brein-Fleming, and Wang-Tsiatis; 2) Equally spaced lower boundary including Gould-Pecore, Pampallona-Tsiatis, Emerson-Fleming, Jennison-Turnbull, and Whitehead-Stratton; 3) Flexible boundary with α spending function including Lan-DeMets, Hwang-Shih-DeCani, and Kim-DeMets.

Online and Local Apps for Sample Size Re-estimation Designs.

Upcoming: Perform 1) conditional probability calculation; 2) Weighted P or weighted test statistics including Bauer-Kohne, Lehmacher-Wassmer, Cui-Hung-Wang; 3) Adjusted test statistics including Gao-Ware-Metha; 4) Promising zone including Chen-DeMets-Lan, Metha-Pocock, Liu-Hu, and Jennison-Turnbull; 5) Stepwise interval adjustment (to avoid back-calculation).

Online and Local Apps for Analyses of Rate(s).

Upcoming: Perform 1) Asymptotic (Wald, Agresti-Coull), Likelihood (Wilson, Hybrid Wilson Brown, Likelihood Ratio), Exact (Clopper-Pearson, Wang-Chang, Mid-P, Blaker), and other (Equal-tailed Jeffreys, Bayesian MOVER, Garwood, Logit, Arcsine) methods for single rate; 2) Asymptotic (Wald, Wald CC, Agresti-Caffo, Hauck-Anderson), Likelihood (Mee, Miettinen-Nurminen, Farrington-Manning, Newcombe, Newcombe CC, Laud-Dane or Miettinen-Nurminen-Brown-Li, Gart-Nam), Exact (Fisher, Santner-Snell, Chan-Zhang), and other (Haldane, Jeffreys-Perks, Brown-Li Jeffreys) methods for comparison of two rates; 3) Rate ratio and odds ratio; 4) Exposure-adjusted rate.

Local Apps for Bland-Altman Analysis.

Upcoming: Perform the Bland-Altman Method for consistency assessment.

Upcoming: Self-host app for Electronic Data Capture System.

How to Access: Please contact help desk for instruction.

Local App for Medical Term Coding according to MedDRA.

V0.1_20240527: Perform the Weighted Ratio Matching (Token Sort, Token Set, and Partial Ratio) for medical term auto-coding; Customize MedDRA version.

V0.2_20250302: Add the Public / Organizational / Personal Synonym Library; Add Adaptive Number Re-supply (per demand).

V0.3_20251216: Fix bugs; Add the auto-filling for searching outcome; Add the Non-major SOC.

Upcoming: Comply with the CDSIC Standard for submission readiness.

Local Apps for Non-compartmental Model Analysis.

Upcoming: Perform relevant data handling convention (logarithm, time course specification, BQL); summarize and visualize time-concentration relationship; the Non-compartmental analysis; CDISC compliance.

Local Apps for Population PKPD Analysis.

Upcoming: Perform relevant data handling convention (merge multiple source); the Non Linear Mixed Effect Model; CDISC compliance.

Local Apps for Bioequivalence Analysis.

Upcoming: Perform sample size calculation and power analysis; Mixed Effect model for Bioequivalence assessment; CDISC compliance.

Local Apps for Immunogenicity Cut Points Calculation.

Upcoming: Perform Immunogenicity Cut Points Calculation.

Upcoming: Self-host app for StratifiedIteriative BlockWeb-based Randomization.Response System.

How to Access: Please contact help desk for instruction.

Online App for Clinical Material Consumption Simulation.

V0.1_20251012: Perform Monte Carlo simulation with the Uniform Participant-center Distribution and the Fixed Number Re-supply strategy.

V0.2_20251016: Add a lag time for the Shipment Period; Add Adaptive Number Re-supply (per demand).

V0.3_20251027: Fix bugs for re-supply; Optimize output with the Ratio of Practical/Theoretical Consumption; Add Adaptive Number Re-supply (per stock level).

V0.4_20251126: Add the Blind Mode (mixture with alternative materials) for re-supply.

Upcoming: Add the Unimodel Participant-center Distribution (1-1/k participants cluster in 1/k centers).