→ Regulatory Affairs
Clinical sections of the dossier
Module 5 clinical sections reflect the underlying study work, so the dossier and the science it describes do not drift apart.
The studies that make the generic case
For a generic to file, the bioequivalence case has to hold up under scrutiny. Most operations do that science once and then re-transcribe it three more times: into the protocol, into the CSR, into the dossier. Krevyos lets the work flow through.
- Domain owner
- Head of Clinical · Biostatistics Lead · CRO Oversight
- Study scope
- Fasted · Fed · Multi-dose · Steady-state · Sprinkle · BCS-based biowaiver
- Standards covered
- ICH E6(R2) GCP · ICH E9 · ICH E3 · EMA BE guideline · FDA OGD product-specific guidance
Capabilities
Protocol design per ICH E9
Bioequivalence protocols designed against the relevant authority's product-specific guidance with the statistical design and acceptance criteria connected to the analytical method and reference product they depend on, so a protocol amendment surfaces every downstream artifact it affects rather than triggering a parallel project to find them.
- Protocol design
- ICH E9
Site management per ICH E6(R2) GCP
Investigator sites managed against GCP: qualification, training, monitoring visits, and corrective actions held as a continuous record per site, not a project folder that closes with the study.
- Site management
- ICH E6(R2) GCP
Statistical analysis and bioequivalence bounds
Statistical analysis plans, primary and secondary endpoints, and bioequivalence bounds linked to the protocol and authority guidance they answer to so a deviation from the plan is a tracked event, not a footnote.
- Statistical analysis
- Bioequivalence bounds
CSR generation per ICH E3
Clinical Study Reports generated from the study record: protocol, statistical analysis, results, and conclusions: rather than written from a spreadsheet.
- CSR generation
- ICH E3
Adverse event capture per ICH E2A
Adverse events captured during BE studies feed the same safety picture as post-marketing data so the product's safety profile is continuous rather than reconstructed at each phase.
- Adverse event capture
- ICH E2A
Touchpoints
→ Pharmacovigilance
Pre-marketing safety from BE studies
Adverse events from bioequivalence studies feed the same safety picture as post-marketing data, so a product's safety profile is continuous rather than reconstructed at each phase.
← Product Design
Reference product and formulation
The reference product strategy and the formulation under test are versioned, connected records so a formulation change surfaces the BE work it might require.
← Analytical Development
Bioanalytical method validation
Bioanalytical methods used in BE studies are held alongside the analytical record: validation, sample stability, and matrix effects are tracked, not just summarized.
Outcomes
- −45%(indicative)
Time from CSR sign-off to dossier integration
The CSR is the work, not a transcription of it. Module 5 inherits the same records the report was generated from.
Re-transcription between study and dossier
Protocols, statistical analyses, and results live in the same data layer as the dossier they support: no parallel maintenance, no drift.
- +2×(indicative)
BE studies running in parallel per team
The clinical team's bandwidth scales with the operation rather than the volume of paperwork around it.
- 100%(indicative)
Audit-grade GCP trail across every study
Every protocol amendment, monitoring finding, and statistical decision carries its provenance: inspection-ready as a steady state.
Figures marked indicative are directional benchmarks against comparable generics operations; per-customer numbers replace them in working sessions.
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