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Software Development Plan

Biometrics

ITEM STATUS LOGS
Study Designer
Dose Escalation Simulator
35%

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.

Proof of Concept Simulator
12%

Online and Local Apps for Proof of Concept Designs.


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

Group Sequential Calculator
42%

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.

Sample Size Re-estimation Calculator
26%

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).

Sample Size Calculator
PoC
Error Rate Controller
PoC
Analytic Intelligence
Rates Evaluator
25%

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.

Meta Synthesizer
PoC
Bland-Altman Evaluator
8%

Local Apps for Bland-Altman Analysis.


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

eDISH Analysis
PoC
Data Management
EDC Trialer
43%

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

MedDRA Coder
88%

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.

WHODD Coder
PoC

Clinical Pharmacology

ITEM STATUS LOGS
Pharmacokinetics and Pharmacodynamics
Time Course Visualization
11%

Upcoming: Local app for data handling and visualization.

Non-compartmental Modeler
36%

Upcoming: Local app for Non-compartmental Model.


Compartmental Modeler
1%

Pending


Population PK Modeler
1%

Upcoming: Local app for population PK Model.


PK Simulator
1%

Pending


Bioequivalence Calculator
8%

Upcoming: Local app for power analysis and mixed effect model.


Assay Testing
In-vitro and In-vivo Correlation
1%
Pending
Immunogenicity Cut Point Calculator
1%

Upcoming: Local app for cut points computation.


Others

ITEM STATUS LOGS
Randomization and Material Consumption
IWRS Trialer
37%

Upcoming: Self-host app for Stratified Block Randomization.

Material Consumption Simulator
94%

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).

Submission Readiness
Data Submission Complier
1%PoC
Pending
eCTD Submission Complier
1%PoC
Pending