Software Development Plan
Biometrics
| ITEM | STATUS | LOGS |
|---|---|---|
| Study Designer | ||
| Dose Escalation Simulator | 34% |
Upcoming: Online simulator for A+B, TPI, mTPI, mTPI2/Keyboard, I3+3, and WW Method. |
| Proof of Concept Simulator | 13% |
Upcoming: Online simulator for Simons' Two Stage Design. |
| Group Sequential Calculator | 31% |
Upcoming: Online calculator for equally spaced upper boundary including Pocock, Haybittle-Peto, O'Brein-Fleming, and Wang-Tsiatis; Equally spaced lower boundary including Gould-Pecore, Pampallona-Tsiatis, Emerson-Fleming, Jennison-Turnbull, and Whitehead-Stratton; Flexible boundary including Lan-DeMets, Hwang-Shih-DeCani, and Kim-DeMets. |
| Sample Size Re-estimation Calculator | 29% |
Upcoming: Online calculator for conditional probability; Weighted P or weighted test statistics including Bauer-Kohne, Lehmacher-Wassmer, Cui-Hung-Wang; Adjusted test statistics including Gao-Ware-Metha; Promising zone including Chen-DeMets-Lan, Metha-Pocock, Liu-Hu, and Jennison-Turnbull; Stepwise interval adjustment (to avoid back-calculation). |
| Sample Size Calculator | 1% |
Pending |
| FWER Controller | 1% |
Pending |
| Data Analysis | ||
| Rates Analysis | 1% |
Pending |
| Meta-Analysis | 1% |
Pending |
| Bland-Altman Analysis | 1% |
Pending |
| eDISH Analysis | 1% |
Pending |
| 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 | 1% |
Pending |
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% |
Pending |
| eCTD Submission Complier | 1% |
Pending |