Infectious Disease

Microbiology-integrated endpoints, PK/PD-supported designs, and submission-ready outputs for antiviral and antibacterial trials.

Clinical & Microbiology Alignment for ID Studies

We connect clinical outcomes with laboratory measures and PK/PD, enabling robust decision-making and regulatory-grade evidence across infectious disease programs.

Endpoints & Assessments

Clinical cure, microbiological eradication, composite endpoints, and hierarchical testing strategies.
Pathogen-specific analyses and susceptibility categorizations with MIC/zone diameter mapping.
Virology endpoints: viral load kinetics, time-to-negativity, and resistance profiling where relevant.
Protocol-aligned visit windows and adjudication for complex clinical outcomes.

PK/PD & Data Integration

Population PK/PD model inputs and exposure–response evaluations tied to clinical endpoints.
Central microbiology data pipelines; reconciliation across LIMS, EDC, and analysis datasets.
Stratification by pathogen class, resistance markers, and baseline burden.
Adaptive dosing or enrichment based on interim PK/PD findings where applicable.

Design, Safety, and Monitoring

Superiority, non-inferiority, and platform designs with robust assumptions and sensitivity analyses.
Interim monitoring, DMC support, and alpha-spending frameworks.
Safety endpoints, AE coding (MedDRA), and exposure-adjusted incidence rates.
Risk-based monitoring with ID-specific KPIs.

Deliverables & Submission Readiness

CDISC-compliant SDTM/ADaM for microbiology and virology domains; traceability from source to TLF.
CSR TLFs: responder curves, shift tables, time-to-event outcomes.
Reviewer guides, define.xml, and responses to authority queries.

Advance Your ID Trials

Coordinate clinical, micro, and PK/PD evidence with Magnus CRO for robust, defensible submissions.

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