M&A Target - Software Capability by Pharma Phase Heatmap

Key software capabilities required at each phase · Click a target vendor to highlight their capabilities

M&A Targets Click to highlight · Click again to deselect · Multiple vendors can be active simultaneously
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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