Immunology

Composite indices, immunogenicity integration, and estimand-aligned analyses for autoimmune and inflammatory indications.

Integrated Immunology Strategies

We design analyses that capture disease dynamics, immunogenicity, and patient-reported outcomes while maintaining robust estimands and traceability.

Endpoints & Indices

Composite indices (e.g., DAS28, SLEDAI) with component-level derivations and thresholds.
Flare definitions and time-to-flare; steroid-sparing endpoints and tapering strategies.
ClinRO/PRO integration; MCID-responder analyses and hierarchical endpoint control.

Immunogenicity, PK/PD & Labs

ADA/NAb data ingestion with assay metadata and sensitivity rules.
PK/PD alignment and exposure–response evaluation.
Lab data reconciliation, grade calculations, and shift tables within CDISC standards.

Estimands, Missing Data & Sensitivity

Estimand definitions per ICH E9(R1) and intercurrent event handling.
MMRM/mixed-effects, MI, delta-adjusted and tipping-point sensitivity analyses.
Subgroup strategies with multiplicity control and transparent reporting.

Deliverables & Regulatory Support

ADaM datasets aligned to indices and flares; reviewer guides and define.xml.
TLFs supporting primary/secondary endpoints, immunogenicity, and safety.
Protocol, SAP, CSR contributions and responses to authority queries.

Strengthen Your Immunology Evidence

Align indices, ADA strategies, and analyses that withstand regulatory scrutiny with Magnus CRO.

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