Key software capabilities required at each phase · Click a target vendor to highlight their capabilities
| Phase | Key Capabilities | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 1 · DiscoveryYrs 1–4 | Computational chemistry / CADD | Target identification & validation | HTS data management | Chemical registration | SAR data capture | Cheminformatics | Assay data management | ||
| 2 · Lead OptimizationYrs 2–5 | ADMET prediction | PBPK modeling | PK/PD informatics | SAR analysis | Multi-parameter optimization | Synthetic chemistry ELN | Species scaling | ||
| 3 · PreclinicalYrs 4–6 | GLP study protocol management | In-life data capture | In vivo safety & efficacy data | SEND submission generation | IND-enabling package assembly | Bioanalytical data management | |||
| 4 · CTS Scale-UpYrs 5–13 | Process development ELN | Batch record management | Formulation development | Analytical method qualification | GMP documentation | Change control | Clinical supply planning | ||
| 5 · Phase IYrs 6–8 | EDC | CTMS | FIH safety monitoring | PK data management | Dose escalation modeling | MTD determination | Intensive AE capture | IND safety reporting | |
| 6 · Phase IIYrs 8–11 | EDC at trial scale | Adaptive trial design | Biomarker informatics | Patient stratification | eCOA / ePRO | RTSM | POC endpoints | Exposure-response modeling | |
| 7 · Phase IIIYrs 10–14 | Large-scale EDC | Pharmacovigilance | CDISC SDTM / ADaM | Statistical analysis packages | Randomization at scale | Global site management | Decentralized trial support | Safety database build | |
| 8 · Commercial Scale-UpYrs 13–16 | Manufacturing execution (MES) | Electronic batch records | Process validation (PPQ) | Tech transfer documentation | Commercial QMS | Serialization / track-and-trace | Multi-site change control | ||
| 9 · RegulatoryYrs 13–15 | IND compilation & management | Regulatory information management (RIM) | eCTD authoring & publishing | CDISC submission validation | Health authority correspondence | Label management | Post-marketing commitments | Medical writing support | |
| 10 · Commercial & RWEYr 15+ | PV signal detection | PSUR / PBRER authoring | RWE study design | RWD sourcing & curation | HEOR economic modeling | Budget impact analysis | HTA submissions | Payer value dossiers | |
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