01
Clinical review
Manual subject, demographics, randomisation, inclusion/exclusion and protocol-record review in both editions.
Investigate your BE study before regulators do.
Detect potential data anomalies, independently verify PK and ANOVA results, and resolve data-integrity concerns before regulatory review.
Submission-ready regulatory workflows
Configured for the submission environments shown below.
BEADS is designed to support authority-specific study designs, acceptance criteria, and guided study setup in accordance with regulatory frameworks used by agencies across the world.
Sponsor-ready workflow
One workspace from study setup to investigation report.
Four connected review layers help sponsor teams move from study setup to evidence-based acceptance, query or escalation.
02
Bioanalytical review
Manual review in Standard. Professional adds automated source-data verification and evidence reconciliation.
03
PK and BE statistics
NCA, descriptive statistics, ANOVA, GMR, confidence intervals and BE decisions are included in both editions.
04
Integrity investigation
Run the common 25-test PK/BE integrity suite and document each flag, finding, limitation and follow-up action.
Plans and annual study packs
Choose Standard or the recommended Professional edition.
Both plans include the same PK, BE statistics and 25-test integrity core. Professional is recommended for sponsors requiring automated bioanalytical verification and evidence reconciliation.
Standard
For sponsor teams that will perform clinical and bioanalytical review manually.
Manual clinical review
Manual bioanalytical review
Full PK, BE statistics and data-integrity core
Professional
For sponsor teams that want automated bioanalytical verification while retaining manual clinical review.
Manual clinical review
Automated bioanalytical source-data verification
Full PK, BE statistics and data-integrity core
| Annual study pack | Standard | Professional · Recommended | Sponsor-side access |
|---|---|---|---|
| 5 studies/year | $2,500First year: $2,000 |
$3,000First year: $2,400 |
1 Sponsor Admin
+
1 Additional User
|
| 10 studies/year | $4,500First year: $3,600 |
$5,500First year: $4,400 |
1 Sponsor Admin
+
2 Additional Users
|
| 15 studies/year | $6,000First year: $4,800 |
$7,500First year: $6,000 |
1 Sponsor Admin
+
3 Additional Users
|
| 20 studies/year | $7,000First year: $5,600 |
$9,000First year: $7,200 |
1 Sponsor Admin
+
4 Additional Users
|
| 25 studies/year | $7,500First year: $6,000 |
$10,000First year: $8,000 |
1 Sponsor Admin
+
5 Additional Users
|
Standard and Professional features
See what is shared and what Professional adds.
Use the three plain-language filters below. The Professional column is highlighted because it is the recommended sponsor plan.
Features
Standard
Professional · Recommended
+Study & Investigation WorkspaceCreate and manage sponsor BA/BE studies from setup through final review.
✓
✓
Study & Investigation WorkspaceCreate and manage sponsor BA/BE studies from setup through final review.
Study register with Draft, In Progress and Completed status
✓
✓
Create an investigation using product, CRO/site and sponsor study code
✓
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Select Clinical and Bioanalytical review sections for each study
✓
✓
Guided eight-stage investigation workflow
✓
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Study-level reviewer notes and progress tracking
✓
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Advanced Bioanalytical Raw Data workflow
—
✓
Automatic analysis-readiness and missing-Raw-Data status
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✓
Expanded evidence, finding and CRO follow-up workflow
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✓
+Regulatory Guideline & Study DesignConfigure the applicable authority, design and special BE pathway.
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Regulatory Guideline & Study DesignConfigure the applicable authority, design and special BE pathway.
Regulatory-authority selection from the configured guideline library
✓
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2-period crossover study design
✓
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3-period partial replicate design
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4-period full replicate design
✓
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Parallel-group study design
✓
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High-variability drug option
✓
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Narrow-therapeutic-index option
✓
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Authority-specific BE limits and RSABE/ABEL pathway
✓
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Guided rationale and step validation
✓
✓
+Clinical ReviewManual Clinical review is included in both subscriptions at present.
✓
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Clinical ReviewManual Clinical review is included in both subscriptions at present.
Manual Clinical checklist: Yes, No, Failed, Not Assessed and Not Applicable
✓
✓
Manual subject and demographic review
✓
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Manual randomisation-list review
✓
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Manual inclusion/exclusion and eligibility review
✓
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Manual sampling and dosing schedule review
✓
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Manual protocol-deviation review
✓
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Manual adverse-event review
✓
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Reviewer comments and evidence references
✓
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+Bioanalytical ReviewStandard provides manual review; Professional adds automatic Raw Data analysis.
✓
✓
Bioanalytical ReviewStandard provides manual review; Professional adds automatic Raw Data analysis.
Manual 12-item Bioanalytical checklist
✓
✓
Manual Method Validation record: method, matrix, LLOQ/ULOQ and calibration model
✓
✓
Manual calibration entry with nominal/measured values and curve summary
✓
✓
Manual QC entry with accuracy, precision/CV and run assessment
✓
✓
Manual stability entry by condition, duration/cycles and reported result
✓
✓
Manual ISR entry using original/repeat values and reviewer conclusion
✓
✓
Manual comments, evidence references and Yes/No/Failed decision
✓
✓
Automatic Method Validation report and Raw Data review
—
✓
Automatic Study Sample Analysis Raw Data review
—
✓
Automatic combined-file classification and Raw Data readiness
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✓
Report-to-source reconciliation
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✓
Run-to-sequence and result-to-report reconciliation
—
✓
Original/repeat/final-result reconciliation
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✓
Reanalysis and reinjection reconciliation
—
✓
ISR source-data reconciliation
—
✓
Automatic review of every supplied chromatogram at the supported evidence level
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✓
Method Validation-to-study comparison
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✓
Dynamic request for missing Raw Data
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Evidence-linked CRO observations
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Advanced Method Validation integrity report
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Advanced Study Sample Analysis integrity report
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✓
+Data Import & ValidationImport concentration data and, in Professional, classify Bioanalytical Raw Data.
✓
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Data Import & ValidationImport concentration data and, in Professional, classify Bioanalytical Raw Data.
Concentration-data import for PK/BE analysis
✓
✓
CSV and TSV import
✓
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XLSX import
✓
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SAS XPT import
✓
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Automatic column mapping and data preview
✓
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Schema and basic integrity validation
✓
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User confirmation before analysis
✓
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Separate Method Validation Raw Data upload area
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Separate Study Sample Analysis Raw Data upload area
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Automatic identification of content inside combined files
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Green/amber/red Raw Data readiness status
—
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Rule-specific analysis enablement when mandatory inputs are available
—
✓
+Pharmacokinetic / NCA AnalysisThe same PK/NCA engine is included in both subscriptions.
✓
✓
Pharmacokinetic / NCA AnalysisThe same PK/NCA engine is included in both subscriptions.
Subject-level concentration–time review
✓
✓
Cmax and Tmax
✓
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AUC0–t
✓
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AUC0–∞
✓
✓
Terminal elimination rate constant (λz/Kel)
✓
✓
Terminal half-life
✓
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AUC extrapolation percentage
✓
✓
AUMC and MRT where applicable
✓
✓
BLQ handling
✓
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Terminal-phase selection support
✓
✓
Descriptive statistics and treatment summaries
✓
✓
+ANOVA & Bioequivalence AssessmentThe same ANOVA, TOST and BE engine is included in both subscriptions.
✓
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ANOVA & Bioequivalence AssessmentThe same ANOVA, TOST and BE engine is included in both subscriptions.
Log-transformed Cmax analysis
✓
✓
Log-transformed AUC0–t analysis
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Log-transformed AUC0–∞ analysis
✓
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Mixed-effects ANOVA for crossover designs
✓
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Mixed-effects ANOVA for replicate designs
✓
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Sequence, subject(sequence), period and treatment effects
✓
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Geometric least-squares means
✓
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Test/Reference geometric mean ratio
✓
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90% confidence intervals
✓
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TOST assessment
✓
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Conventional average bioequivalence limits
✓
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RSABE/ABEL pathways for eligible highly variable drugs
✓
✓
Narrow-therapeutic-index limits where configured
✓
✓
ISCV, power and final BE/Not-BE conclusion
✓
✓
+Sample Size & PowerBoth sample-size calculation pathways are included in both subscriptions.
✓
✓
Sample Size & PowerBoth sample-size calculation pathways are included in both subscriptions.
Prospective sample-size calculation using expected GMR and ISCV
✓
✓
Pilot-CI back-calculation of ISCV followed by sample-size estimation
✓
✓
2×2 crossover calculation
✓
✓
Partial replicate calculation
✓
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Full replicate calculation
✓
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Parallel-design calculation
✓
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Average bioequivalence pathway
✓
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Highly variable drug pathway
✓
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Narrow-therapeutic-index pathway
✓
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FDA and EMA configuration
✓
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Target power and dropout allowance
✓
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Save result for study planning
✓
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+Data Integrity InvestigationThe core DABERS-style and 25-test integrity suite is included in both subscriptions.
✓
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Data Integrity InvestigationThe core DABERS-style and 25-test integrity suite is included in both subscriptions.
Core DABERS-style anomaly screening
✓
✓
25-test advanced integrity scorecard
✓
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Individual Pass, Warning and Fail status
✓
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Decision-grade, supportive and screening-only labels
✓
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Cross-test correlation and visual diagnostics
✓
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Finding-by-finding reviewer conclusion and next-step workflow
✓
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1. EDA — ln(Cmax) Bar Analysis
✓
✓
2. Linear Mixed Effects ANOVA
✓
✓
3. Residual Analysis
✓
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4. Runs Test (Non-Parametric)
✓
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5. Sequential CI Analysis
✓
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6. MSE Analysis
✓
✓
7. SaToWiB Profile Similarity
✓
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8. Ranking Analysis
✓
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9. Correlation Analysis (R²)
✓
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10. Normalization & Scaling
✓
✓
11. Group-wise Comparative Analysis
✓
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12. ANOVA — ln(T/R) Variance
✓
✓
13. PCA — Multidimensional Detection
✓
✓
14. K-Means Clustering
✓
✓
15. Wilcoxon Rank Sum
✓
✓
16. Benford’s Law — First Digit
✓
✓
17. Digit Preference — Last Digit
✓
✓
18. Tmax Clustering Detection
✓
✓
19. AUC Extrapolation Fraction
✓
✓
20. Terminal Phase Quality (λz R²)
✓
✓
21. ISCV Consistency Check
✓
✓
22. Split-Half GMR Stability
✓
✓
23. Bootstrapped CI Stability
✓
✓
24. Crossover Balance Check
✓
✓
25. Period Outlier Asymmetry
✓
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Link Bioanalytical Raw Data findings with PK integrity signals
—
✓
Combined sponsor view of PK signals and Bioanalytical evidence gaps
—
✓
+Findings, CRO Observations & Follow-upProfessional adds automatic evidence requests and Bioanalytical findings.
✓
✓
Findings, CRO Observations & Follow-upProfessional adds automatic evidence requests and Bioanalytical findings.
Reviewer justification for integrity and BE results
✓
✓
Manual finding and investigation notes
✓
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Basic integrity findings report
✓
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Manual CRO follow-up workflow
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Automatic finding creation from Advanced Bioanalytical rules
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✓
Select findings for a controlled CRO observation report
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Generate targeted Raw Data requests linked to blocked analyses
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Store the CRO response separately from the original finding
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Sponsor accept, reject, clarify or reopen decision workflow
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✓
+Reports, Archive & AuditProfessional adds Advanced Bioanalytical reports and CRO documents.
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Reports, Archive & AuditProfessional adds Advanced Bioanalytical reports and CRO documents.
BE analysis report
✓
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25-test integrity findings report
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Report archive and version timeline
✓
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Reviewer justification workflow
✓
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Available electronic-signature workflow
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Audit-log visibility for controlled actions
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Advanced Method Validation Integrity Report
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✓
Advanced Study Sample Analysis Integrity Report
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Raw Data readiness and missing-evidence appendix
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CRO Raw Data Request
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CRO Observation Report
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Evidence-linked tables, graphs and final sponsor conclusion
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✓
+Sponsor Administration & AccessCore sponsor administration is common; advanced modules are enabled by package entitlement.
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Sponsor Administration & AccessCore sponsor administration is common; advanced modules are enabled by package entitlement.
Organisation-scoped sponsor access
✓
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User roles and authorised study access
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Subscription visibility
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Seat visibility
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Study-credit visibility
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Documents and support-request access
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Professional Bioanalytical module entitlements
—
✓
Configurable seats, study credits, term, support and price
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✓ Included— Not includedBlue bullet = capability added in Professional
PK, BE and sponsor-workflow comparison
BEADS compared with SAS and Phoenix WinNonlin.
The three platforms serve different primary purposes. BEADS is designed as a guided sponsor-side BE review and data-integrity workflow; SAS is a broad, highly programmable statistical environment; and Phoenix WinNonlin is a specialist PK/PD, NCA and bioequivalence analysis platform.
| Feature | BEADS | SAS | Phoenix WinNonlin |
|---|---|---|---|
| Primary purpose | Integrated sponsor review of clinical, bioanalytical, PK/BE and data-integrity evidence before submission. | General-purpose statistical programming, data management, modelling and reporting across many industries and study types. | Specialist pharmacokinetic, pharmacodynamic, toxicokinetic, NCA and bioequivalence analysis. |
| User workflow | Guided, study-based workflow with agency setup, structured review steps, findings and sponsor reports. | Analyses are created through SAS procedures, code, macros and organisation-specific programs. | Graphical project workflow using worksheets, object mappings, NCA, modelling and bioequivalence objects. |
| Programming | No coding for the configured BE review workflow. | Programming is normally required to prepare data, specify models, automate outputs and maintain validated programs. | No coding is required for standard graphical workflows, although correct object configuration and mappings are required. |
| Expertise required | Guided for sponsor teams; qualified scientific review remains necessary for findings and conclusions. | Requires statistical-programming and model-selection expertise. | Requires PK/NCA and bioequivalence expertise to configure analyses and interpret outputs correctly. |
| Data import and mapping | Excel and CSV import with guided mapping, validation and study-specific organisation. | Supports broad data access and import, but preparation, restructuring and quality checks are generally programmed. | Imports structured worksheets/files and requires column mapping to the selected analysis object. |
| Data organisation | Automatically organises mapped data into the sponsor study workflow and review modules. | Fully flexible, but organisation and reconciliation depend on the user’s programs and standards. | Project- and worksheet-based organisation with analysis objects and mapped variables. |
| Study designs | Guided support for standard crossover, replicate and parallel BE designs, with configured regulatory pathways. | Can analyse major and customised designs when the appropriate statistical model is programmed. | Average BE workflows support nonreplicated crossover, replicated crossover and parallel designs; additional individual/population BE workflows are also available. |
| PK / NCA analysis | Integrated PK calculation and sponsor review within the same BE investigation. | Possible through programmed calculations, procedures or validated organisation-specific workflows. | Core strength: dedicated NCA and PK/PD/TK analysis with integrated data processing, tables and graphics. |
| ANOVA and confidence intervals | Automated, design-aware BE analysis with guided GMR, confidence-interval and conclusion presentation. | Powerful and highly customisable ANOVA, GLM and mixed-model capability when correctly programmed. | Integrated bioequivalence models, confidence intervals and model outputs based on the selected study design and mappings. |
| Power and sample-size assessment | Included in the guided BE workflow for configured designs. | Available through SAS power and sample-size procedures, including equivalence analyses, with user-defined inputs and code. | Provides TOST power output and supports planning workflows; setup and interpretation remain user-controlled. |
| Clinical review | Dedicated sponsor workspace for subject, demographic, randomisation, inclusion/exclusion and related review. | No dedicated out-of-the-box sponsor BE clinical-review workspace; can be built through custom data and reporting programs. | Not primarily designed as a clinical source-data review platform. |
| Bioanalytical review | Manual review in Standard and automated bioanalytical verification in Professional, including MV and study-result consistency checks. | Can analyse bioanalytical data when suitable datasets, rules and programs are created, but the workflow is not purpose-built by default. | Concentration data can feed PK analyses, but full method-validation and study-source integrity review is not its primary purpose. |
| Data-integrity and anomaly screening | Integrated PK integrity scorecard plus method-validation and bioanalytical study-result checks, with affected records and investigation outputs. | Custom anomaly tests can be programmed, but the user must design, validate, maintain and interpret the complete framework. | Provides analytical and diagnostic outputs, but is not positioned as an integrated sponsor-side BE data-integrity investigation suite. |
| Sponsor collaboration and follow-up | Findings, reviewer roles, CRO questions, evidence requests and sponsor conclusions are managed in one platform. | Requires separate workflow, document-management or reporting systems unless custom-developed. | Primarily an analysis environment; sponsor queries and investigation follow-up normally occur outside the application. |
| Reports and traceability | Sponsor-focused reports, findings, review status, study credits, user roles and controlled workflow history. | Highly configurable reporting and reproducible code logs, subject to the organisation’s validation and governance controls. | Analysis outputs, worksheets, tables, charts and project history within the Phoenix project environment. |
| Best suited for | Sponsors seeking one guided environment to review BE evidence, independently verify results and investigate integrity signals. | Organisations needing maximum statistical flexibility and having experienced programmers and validated coding standards. | Scientists needing an established specialist environment for PK/NCA, modelling and conventional BE analysis. |
Capabilities can vary by product version, licence and organisational configuration. BEADS does not replace qualified scientific review, and third-party product capabilities should be confirmed before public commercial use.
Integrity and verification coverage
Review PK patterns, method validation evidence and bioanalytical study results.
Each area is presented separately so sponsors can understand the purpose, review logic and significance of the available checks. Findings are investigation signals and do not independently prove data manipulation.
PK Data Integrity Scorecard — 25 Statistical TestsOutlier, similarity, non-parametric and trend-based screening of PK and BE datasets.25 tests
| # | Test name | Classification | How it supports anomaly detection |
|---|---|---|---|
| 1 | Boxplot / Interquartile Range (IQR) | Outlier Analysis | Flags PK values (e.g., Cmax, AUC) that fall beyond 1.5× the interquartile range. Fabricated or “cleaned” values often sit suspiciously just inside or outside this fence — close enough to look normal, but not quite genuine. |
| 2 | Z-Score (Standardised Residual) | Outlier Analysis | Measures how many standard deviations a value is from the group mean. A large Z-score (>2 or >3) means the value doesn’t fit the normal spread of the rest of the subjects. |
| 3 | Robust Z-Score (Median / MAD) | Outlier Analysis | A tougher version of the Z-score that uses the median instead of the mean, so it isn’t distorted by other outliers already present. Still catches manipulation even when several outliers exist in the same dataset. |
| 4 | Grubbs’ Test (ESD) | Outlier Analysis | A formal statistical test that proves whether the single most extreme point truly does not belong to the dataset — useful when a value appears to have been altered to help a study pass or fail. |
| 5 | Dixon’s Q Test | Outlier Analysis | Compares a suspicious value against its nearest neighbours. Sensitive enough to catch even one altered value in small BE datasets (24–36 subjects), where manipulation is easiest to hide. |
| 6 | Studentized Residual | Outlier Analysis | Standardises the leftover error after fitting a regression line. A value manually adjusted to “fit” a trend shows an abnormally large residual once properly standardised — exposing forced-fit data. |
| 7 | β Slope (Linear Regression) | Similarity Check | Fits a straight-line trend through paired data and checks the slope. Unnatural slope deviations appear when real biological variability has been replaced with “cleaner”, smoothed numbers. |
| 8 | β Slope (Scaling Pattern) | Similarity Check | Checks whether one subject’s values are a near-perfect scaled version of another’s. Perfect or near-perfect linear scaling is a red flag, since real biological data is never that clean. |
| 9 | Average Percentage Difference (APD) | Similarity Check | Calculates the average percentage difference between paired values across subjects or arms. An unusually small or consistent APD suggests values were copy-adjusted rather than independently measured. |
| 10 | f₂ Similarity Factor | Similarity Check | A standard measure of how similar two profiles are. A suspiciously high f₂ (too similar) suggests one profile was derived or copied from another rather than independently measured. |
| 11 | Wilcoxon Rank Sum | Non-parametric Test | Compares the ranking (order) of two groups of values rather than their raw numbers. Manipulated data tends to cluster in rank in ways that don’t reflect true random biological sampling. |
| 12 | Tmax Clustering Detection | Non-parametric Test | Looks at how many subjects share the exact same Tmax (time of peak concentration). Excessive identical Tmax values across “different” subjects suggest numbers were copied or interpolated rather than observed. |
| 13 | EDA — ln(Cmax) Bar Analysis | Trend Analysis | Visually and statistically compares log-transformed Cmax values across subjects. Bars that are too uniform, or that repeat a pattern, indicate templated or copied data. |
| 14 | Runs Test (Non-Parametric) | Trend Analysis | Checks whether increases and decreases in a sequence occur in a truly random order. Detects non-random patterns — e.g., every alternate subject being “adjusted” — that shouldn’t exist in real data. |
| 15 | Sequential CI and GMR Analysis | Trend Analysis | Tracks how the confidence interval and GMR evolve as subjects are added one by one. An unnatural “jump” to pass criteria near the final subjects, instead of gradual convergence, signals manipulation. |
| 16 | PCA — Multidimensional Detection | Trend Analysis | Reduces many PK variables into a few dimensions to visualise how subjects cluster together. Manipulated subjects can show up as a separate cluster even when no single variable looks abnormal alone. |
| 17 | K-Means Clustering | Trend Analysis | Groups subjects automatically based on overall similarity across parameters. Manipulated subjects often form an unnaturally tight or separate cluster instead of blending into organic, overlapping groups. |
| 18 | Group-wise Comparative Analysis | Trend Analysis | Compares statistics across sequence, period, or site sub-groups. A mismatch in group-level statistics suggests manipulation was targeted at a specific subgroup. |
| 19 | ANOVA — ln(T/R) Variance | Trend Analysis | Examines the residual (unexplained) variance from the standard BE ANOVA model. Artificially low, unexplained variance suggests real biological noise was suppressed. |
| 20 | Residual Analysis | Trend Analysis | Studies the pattern left over after fitting the expected statistical model. Fabricated points often leave a non-random pattern in residuals, unlike genuine measurement error. |
| 21 | ISCV Consistency Check | Trend Analysis | Checks whether the intra-subject coefficient of variation (ISCV) is realistic for the drug and analytical method. An implausibly low ISCV suggests smoothing or fabrication, since real variability rarely comes out that tight. |
| 22 | Terminal Phase Quality (λz R²) | Trend Analysis | Checks the goodness-of-fit (R²) of the terminal elimination phase used to calculate λz. A suspiciously perfect R² (0.999+) across many subjects suggests values were smoothed or back-calculated. |
| 23 | Benford’s Law — First Digit | Trend Analysis | Compares the distribution of leading digits in the dataset to the expected natural pattern. Fabricated numbers rarely follow Benford’s expected leading-digit distribution. |
| 24 | Bootstrapped CI Stability | Trend Analysis | Resamples the dataset repeatedly to see how stable the confidence interval remains. An unstable CI on resampling suggests a small number of manipulated points are driving the result. |
| 25 | Period Outlier Asymmetry | Trend Analysis | Checks whether outliers are evenly spread across study periods or concentrated in just one. Outliers clustering heavily in one period only suggest selective adjustment tied to formulation or period. |
Method Validation Review TestsStructured checks of MV design, experiment results, report consistency and applicability to the study.MV review
| # | Review test / area | What BEADS checks | Why it matters |
|---|---|---|---|
| 1 | Protocol-to-report coverage | Compares planned validation experiments and acceptance criteria with the final MV report. | Helps identify omitted experiments, incomplete reporting, or unsupported conclusions. |
| 2 | Calibration range, model and weighting | Reviews the validated range, curve model, weighting, accepted points, and actual study use. | Confirms that the study remains within the validated analytical conditions. |
| 3 | Accuracy and precision | Reconciles within-run and between-run performance with experiment-level results. | Identifies inconsistencies between source results and reported summary statistics. |
| 4 | Selectivity and sensitivity | Reviews blank, zero, LLOQ, interference, and sensitivity evidence. | Supports confidence that the method can distinguish and quantify the analyte reliably. |
| 5 | Recovery and matrix effect | Checks recovery and matrix-effect results across lots, levels, and experimental conditions. | Highlights selective reporting or unsupported generalisation across matrices. |
| 6 | Stability verification | Reconciles bench-top, freeze-thaw, processed-sample, stock, and long-term stability results. | Confirms that reported sample handling and storage are supported by validation evidence. |
| 7 | Repeat and selective-reporting review | Identifies unexplained repeats, excluded experiments, or inclusion of only favourable outcomes. | Supports investigation of incomplete or outcome-directed reporting. |
| 8 | MV-to-study applicability | Compares the validated method with actual study use, laboratory, matrix, equipment, and sample preparation. | Identifies possible partial-validation, cross-validation, or unsupported-use triggers. |
Bioanalytical Study & Project Report Review TestsSource-to-report reconciliation across analytical runs, samples, concentrations and the final PK input dataset.Study report
| # | Review test / area | What BEADS checks | Why it matters |
|---|---|---|---|
| 1 | Sequence and acquisition chronology | Reviews injection order, timestamps, missing or duplicate injections, sequence gaps, and calibration/QC placement. | Identifies chronology concerns and incomplete electronic-history evidence. |
| 2 | Run composition and acceptance | Reconciles each analytical run, accepted or rejected status, QC distribution, and bracketing. | Checks whether the reported run decision is supported by the complete run inventory. |
| 3 | Calibration and QC reconciliation | Compares source calibration and QC values, exclusions, calculations, and final run conclusions. | Highlights unsupported exclusions, altered summaries, or incorrect acceptance decisions. |
| 4 | Internal-standard and retention-time behaviour | Reviews IS response, retention-time drift, assignment patterns, and repeated chromatographic behaviour. | Helps detect unusual analytical patterns requiring chromatogram or audit-trail review. |
| 5 | Carryover assessment | Checks high-to-blank positions, predose findings, and carryover-decay patterns. | Supports evaluation of whether reported concentrations may be influenced by preceding injections. |
| 6 | Duplicate or reused data screening | Screens areas, ratios, concentrations, retention times, and numerical or file fingerprints for unexplained similarity. | Identifies record pairs that require source-file and preparation-record investigation. |
| 7 | Concentration-result reconciliation | Compares source results, report tables, transfer files, and the final PK input record by record. | Detects omitted records, mapping errors, or downstream changes in concentration data. |
| 8 | Repeat, reanalysis, reinjection and ISR | Reviews the original-to-final chronology, reasons, decision rules, and selected final values. | Helps identify unexplained repeats, directional result selection, or inconsistent ISR handling. |
Software module gallery
Scroll through the review workflow.
Use the arrows or horizontal scroll. Select any image to open it at full size without leaving the website.
Software module
Sponsor study dashboard
Study status, active investigations, and analysis modules in one sponsor workspace.
Software module
Create a new investigation
Set product, CRO/site, sponsor code, and the review modules required for the study.
Software module
Regulatory guideline setup
Choose the submission environment and carry the applicable study-design and BE pathway through the workflow.
Software module
Study design selection
Configure crossover, replicate, parallel, HVD, and NTI study options.
Software module
PK and BE result review
Review GMRs, confidence intervals, acceptance limits, and the final BE conclusion.
Software module
Advanced integrity scorecard
Review flags, confidence levels, next steps, and evidence-linked investigation findings.
Software module
Clinical review workspace
Review subject data, demographics, randomisation, and inclusion/exclusion information.
Software module
Bioanalytical review workspace
Review method validation, calibration, QC, stability, ISR, and source-data evidence.
Sponsor login and portal
Experience a clear view of how sponsors will access, manage and monitor their BEADS account.
The Sponsor Admin controls the organisation workspace and can invite role-based users within the purchased package.
Dashboard
Organisation, role, subscription status, study credits, users, invitations, and documents at a glance.
Confidentiality and data security
Sponsor study data remains private to the sponsor organisation.
Confidential by design
No sponsor can see another sponsor's studies. BEADS personnel have no routine access to sponsor study data. Any exceptional support access must be explicitly authorised by the Sponsor Admin, limited to the approved purpose and time, and recorded in the audit history.
Isolated sponsor workspaces
Organisation-level tenant separation prevents cross-sponsor visibility of studies, users, findings, documents and reports.
Sponsor-controlled roles
The Sponsor Admin controls invitations and assigns Analyst, Reviewer, Study Manager or Read Only access according to responsibilities.
Least-privilege support access
Support staff do not browse sponsor data. Exceptional access requires sponsor approval, a defined support reason and logged activity.
Encryption and secure transfer
Production deployment is expected to use encryption in transit and at rest, secure upload channels and controlled download/report permissions.
Audit trail and accountability
User actions, study usage, findings, reviews, report versions and authorised access events are retained for traceability.
Retention and deletion control
Retention, backup, archive and secure deletion periods are governed by the subscription agreement and sponsor-approved data-processing terms.
Common questions
Frequently asked questions about plans, access and integrity review.
Clear answers for sponsors evaluating BEADS and preparing for a trial or subscription discussion.
What is the difference between Standard and Professional?+
Both editions include the same PK analysis, BE statistics, ANOVA and 25-test integrity scorecard. Standard uses manual clinical and manual bioanalytical review. Professional keeps clinical review manual and adds automated bioanalytical source-data verification and evidence reconciliation.
How does the 20% first-year discount work?+
The launch offer reduces the selected annual subscription price by 20% for the first subscription year. The standard annual price is displayed alongside the discounted first-year amount.
How many sponsor users are included?+
Every package includes one Sponsor Admin. The 5-study package adds 1 user; 10 studies adds 2 users; 15 studies adds 3 users; 20 studies adds 4 users; and 25 studies adds 5 users.
Which roles can be assigned to additional users?+
The Sponsor Admin can invite additional users and assign them as Analyst, Reviewer, Study Manager or Read Only, subject to the number of users included in the selected package.
Does an integrity flag prove data manipulation?+
No. A flag identifies an unusual value, pattern, inconsistency or source-data concern that requires scientific and documentary investigation. The sponsor should review the affected records and obtain appropriate evidence or explanation from the CRO.
What data can be reviewed in BEADS?+
BEADS is designed to review clinical information, bioanalytical method-validation evidence, bioanalytical study results, concentration-time data, PK calculations, ANOVA and bioequivalence conclusions. The exact assessment depends on the source files supplied.
Is sponsor study data kept separate and confidential?+
The platform is designed around separate sponsor workspaces and role-based access. Users from one sponsor organisation should not be able to access another sponsor’s studies. Final security commitments will be governed by the production architecture and subscription/data-processing agreements.
What happens after I request a trial?+
The BEADS team will review the submitted details and contact the sponsor to understand the expected study volume, review requirements and preferred edition. As the platform is in final testing, the initial interaction may include a guided preview before trial access is activated.
Can BEADS replace scientific review by the sponsor?+
No. BEADS supports structured review, independent calculations and anomaly identification. Final interpretation, CRO queries and submission decisions remain the responsibility of qualified sponsor personnel.
Early-access and subscription interest
Register your interest while BEADS completes final testing.
BEADS is in the final stage of testing. The fully functional and tested software will be launched after completion of verification. Meanwhile, interested sponsors are invited to review the current interface and share their preferred edition and annual study pack.
Selected package
Professional · 5 studies/year · 1 Sponsor Admin + 1 additional user · $2,400 first-year launch price ($3,000 standard annual price)
- Professional is recommended for automated bioanalytical verification.
- Clinical review remains manual in both plans at present.
- Additional users can be Analyst, Reviewer, Study Manager or Read Only.
